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On January 16, 2025, SAMHSA, under the Department of Health and Human Services (HHS), published the &ldquo;<a title="Read the full updated guidelines as published by the US HHS" href="https://www.federalregister.gov/documents/2025/01/16/2025-00425/mandatory-guidelines-for-federal-workplace-drug-testing-programs-authorized-testing-panels" target="_blank" rel="noopener">Mandatory Guidelines for Federal Workplace Drug Testing Programs &ndash; Authorized Testing Panels</a>&rdquo; via the Federal Register /Vol. 90, No. 10/Thursday, January 16, 2025/Rules and Regulations 
These revisions will take effect for any samples received by the laboratory on July 7, 2025, regardless of the collection date. These changes apply only to federal agency workplace drug testing programs. They DO NOT apply to drug testing programs regulated by the DOT, the U.S. Coast Guard (USCG), or the Nuclear Regulatory Commission (NRC). 
What's Changing for You
<ol class="branded" style="list-style: auto; padding-inline-start: 40px;">
<li>Fentanyl has been added to the testing panel.</li>
</ol>
<table style="border: 1px solid #167ebb; margin: 1rem auto 1rem auto;">
<thead style="background-color: rgba(22,126,187,.2);">
<tr>
<th>&nbsp;</th>
<th style="border: 1px solid #167ebb; padding: 5px 10px;">Screening cutoff</th>
<th style="border: 1px solid #167ebb; padding: 5px 10px;">Confirmation cutoff</th>
</tr>
</thead>
<tbody>
<tr>
<td style="border: 1px solid #167ebb; padding: 5px 10px;">Fentanyl</td>
<td style="border: 1px solid #167ebb; padding: 5px 10px;">1 ng/ml</td>
<td style="border: 1px solid #167ebb; padding: 5px 10px;">1 ng/ml</td>
</tr>
<tr>
<td style="border: 1px solid #167ebb; padding: 5px 10px;">Norfentanyl</td>
<td style="border: 1px solid #167ebb; padding: 5px 10px;">&nbsp;</td>
<td style="border: 1px solid #167ebb; padding: 5px 10px;">1 ng/ml</td>
</tr>
</tbody>
</table>
<ol class="branded" style="list-style: auto; padding-inline-start: 40px;" start="2">
<li>Abbreviations for THC and its metabolites have been updated. HHS previously used the abbreviation THC for &Delta;-9-tetrahydrocannabinol and THCA for &Delta;-9-tetrahydrocannabinol-9-carboxylic acid.</li>
</ol>
<table style="border: 1px solid #167ebb; margin: 1rem auto 1rem auto;">
<thead style="background-color: rgba(22,126,187,.2);">
<tr>
<th style="border: 1px solid #167ebb; padding: 5px 10px;">Old Nomenclature</th>
<th style="border: 1px solid #167ebb; padding: 5px 10px;">New Nomenclature</th>
</tr>
</thead>
<tbody>
<tr>
<td style="border: 1px solid #167ebb; padding: 5px 10px;">THC</td>
<td style="border: 1px solid #167ebb; padding: 5px 10px;">&Delta;9THC</td>
</tr>
<tr>
<td style="border: 1px solid #167ebb; padding: 5px 10px;">THCA</td>
<td style="border: 1px solid #167ebb; padding: 5px 10px;">&Delta;9THCC</td>
</tr>
</tbody>
</table>
The current panels remain in effect until July 6, 2025. Again, the US DOT and US NRC testing programs remain unaffected at this time.
In addition, the US DOT has not yet adopted the 10/12/23 HHS UrMG revision regarding a 4000 ng/mL morphine confirmatory cutoff.
If you have any questions, please contact Omega Laboratories at <a title="Call Omega Laboratories" href="tel:1-289-919-3188" target="_blank" rel="noopener">+1-289-919-3188</a> or email <a title="Email Omega Laboratories customer service" href="mailto:customerservice@omegalabs.net" target="_blank" rel="noopener">customerservice@omegalabs.net</a>.

On January 16, 2025, SAMHSA, under the Department of Health and Human Services (HHS), published the “Mandatory Guidelines for Federal Workplace Drug Testing Programs – Authorized Testing Panels” via the Federal Register /Vol. 90, No. 10/Thursday, January 16, 2025/Rules and Regulations

Important notice for Canadian clients: Changes to US HHS Drugs of Abuse testing panel

MOGADORE, Ohio, March 18, 2025 /PRNewswire/ -- <a title="Download a PDF of this press release" href="http://res.cloudinary.com/dnginndga/image/upload/v1742303561/omega-prod/Omega Laboratories Completes Method Validation With Cannabix Technologies Inc 03_2025_Final-39e1d503-ae89-43ad-a41d-526fc1c81f93.pdf" target="_blank" rel="noopener">Download as PDF</a> -- Omega Laboratories, a leading drug testing laboratory renowned for its comprehensive services, proudly announces the development and validation of a marijuana breath test. This validation includes a test method for the simultaneous quantification of &Delta;-9-tetrahydrocannabinol (THC), &Delta;-8-THC, cannabidiol (CBD), and cannabinol (CBN) in breath aerosols collected using Cannabix Technologies&rsquo; Breath Collection Unit (BCU). This establishes Omega and Cannabix as the premier technology for collecting and testing breath for recent marijuana usage. This method validation marks a significant milestone in the pursuit of innovative solutions for drug testing and safety assurance.
Cannabix Technologies Inc. and Omega have collaborated to optimize the design of the Cannabix BCU and compact Breath Cartridge technology. &nbsp;The BCU includes a start-up unit air flow self-check, the ability to collect an ambient air sample to rule out external contamination from the immediate surrounding area, a split sample configured Breath Cartridge to simultaneously collect an A and B sample, and a collection system that will stop drawing in air should the donor stop breathing into the device. This prevents the device from pulling in ambient air from the surrounding area and a donor from trying to cheat the collection. The Cannabix BCU is at the forefront of advanced breath collection tools to collect breath accurately and non-invasively.
Omega Laboratories is currently in the process of incorporating breath testing into its suite of services. With credible and extensive research backing Cannabix's technology, including validation studies demonstrating its efficacy, Omega Laboratories is confident in the reliability and accuracy of the THC breath test system. In partnership with Cannabix, Omega has completed a full validation study that will be published to further demonstrate the effectiveness of the breath testing system in real-world testing scenarios.&nbsp; This will ensure unparalleled accuracy and reliability for clients.
"At Cannabix Technologies, we are thrilled with the method validation results from Omega Laboratories, a company that upholds a tradition of excellence in drug testing, backed by their extensive accreditations and certifications,", stated, Rav Mlait, CEO of Cannabix Technologies Inc. "This partnership success further solidifies our commitment to providing trusted and highly accredited solutions, offering unparalleled expertise and reliability to future clients."
The integration of Cannabix's THC BCU technology with Omega Laboratories' testing protocols will enable rapid and precise detec&shy;&shy;tion of THC levels in breath samples. This innovative approach not only streamlines the testing process but also ensures reliable results for clients across various industries, including law enforcement, workplace safety, and healthcare.
Furthermore, as part of this collaboration, all breath samples analyzed by Omega Laboratories undergo a testing process using mass spectrometry (mass spec), a gold standard in analytical chemistry to confirm which analytes are present. This meticulous approach reinforces Omega's commitment to maintaining the highest forensic standards of quality and integrity.
With the rise in cannabis legalization, employers face new challenges in detecting recent use of marijuana. Traditional cannabis testing methods, such as oral fluid, urine, and hair tests, can detect cannabis use for extended periods, ranging from days to months. The premier solution for recent use detection will be utilizing the Cannabix BCU to collect breath then sending the sample to Omega for analysis. Omega will then detect if there was recent THC usage (minutes to several hours).
"Our partnership with Cannabix Technologies underscores our commitment to staying at the forefront of advancements in drug testing technology," said Bill Corl, CEO of Omega Laboratories. "By incorporating their groundbreaking THC breath collection technology, we are poised to enhance the accuracy, efficiency, and accessibility of cannabis testing."
For additional information on these solutions, please contact Omega at <a title="Call Omega Laboratories for additional information on breath testing solutions and more" href="tel:1-800-665-5569">1-800-665-5569</a> or <a title="Email Omega Laboratories for additional information on breath testing solutions and more" href="mailto:sales@omegalabs.net">sales@omegalabs.net</a>.

Omega Laboratories, a leading drug testing laboratory renowned for its comprehensive services, proudly announces the development and validation of a marijuana breath test. This validation includes a test method for the simultaneous quantification of Δ-9-tetrahydrocannabinol (THC), Δ-8-THC, cannabidiol (CBD), and cannabinol (CBN) in breath aerosols collected using Cannabix Technologies’ Breath Collection Unit (BCU). This establishes Omega and Cannabix as the premier technology for collecting and testing breath for recent marijuana usage. This method validation marks a significant milestone in the pursuit of innovative solutions for drug testing and safety assurance.

Omega Laboratories Completes Method Validation with Cannabix Technologies Inc. for Marijuana Breath Detection

MOGADORE, Ohio,&nbsp;October 17, 2023&nbsp;/PRNewswire/ -- Omega Laboratories, Inc. (Omega), a leading provider of comprehensive drug testing solutions, announces that its state-of-the-art laboratory in Ontario, Canada has received Substance Abuse and Mental Health Services Administration (SAMHSA) accreditation from the National Laboratory Certification Program (NLCP). This prestigious accreditation solidifies Omega&rsquo;s commitment to quality, accuracy, and integrity in drug testing while providing another example of how Omega continues to evolve in order to better serve our clients.
SAMHSA&rsquo;s rigorous evaluation process ensures that only a select group of accredited laboratories, meeting or exceeding the industry's highest requirements, can be accredited to this esteemed program. There are currently less than 20 laboratories in North America holding SAMHSA accreditation. This exclusive status underscores Omega Laboratories' exceptional commitment to excellence and positions Omega among the most distinguished in the field.
&ldquo;We are proud to receive SAMHSA accreditation for our Ontario laboratory,&rdquo; said Jerry Crosby, President of Omega Laboratories. &ldquo;This achievement further demonstrates our expertise in forensic toxicology and underscores our commitment to providing quality service and reliable turnaround times.&rdquo;
The SAMHSA accreditation positions Omega as a trusted partner for businesses, organizations, and institutions in need of comprehensive drug testing services. Omega has over 22 years of experience with advanced specimens such as oral fluid and hair. Oral fluid has recently been accepted and hair is pending acceptance for SAMHSA testing. &nbsp;Having this credential for urine testing will now enable Omega to add hair and oral fluid quickly to its SAMHSA test menu.
The importance of the SAMHSA accreditation extends beyond the validation of Omega&rsquo;s proficiency and compliance. It also brings Omega&rsquo;s excellent client service, industry-leading turnaround time and technology solutions to the federally regulated drug testing market. With this accreditation, Omega is well-positioned to cater to a wider range of clientele, including government agencies, law enforcement organizations, and workplace programs. SAMHSA is required to test for key safety-sensitive candidates such as those employed under the Department of Transportation (FMCSA, FAA, FRA), energy (PHMSA, NRC) and armed services (DoD, DHS/USCG). This type of testing contributes to public safety in communities by keeping roadways and other forms of transportation safe.
For additional information on these solutions, please contact Omega at 1-800-665-5569 or&nbsp;sales@omegalabs.net.

Omega Laboratories has achieved SAMHSA accreditation, ensuring the highest standards in drug testing services. Learn more about this milestone.

Omega Laboratories Achieves SAMHSA Accreditation

MOGADORE, Ohio, May 16, 2024 /PRNewswire/ -- Omega Laboratories, a leading drug testing laboratory renowned for its comprehensive services, proudly announces its strategic partnership with Cannabix Technologies Inc., a pioneer in cannabis breathalyzer technology. This partnership establishes Omega as the exclusive provider of laboratory services. This collaboration marks a significant milestone in the pursuit of innovative solutions for drug testing and safety assurance.
Cannabix Technologies Inc. is at the forefront of developing advanced breath analysis tools to detect THC levels accurately and non-invasively. Leveraging their expertise and cutting-edge technology, Omega Laboratories aims to revolutionize the landscape of drug testing by integrating Cannabix's THC breathalyzer into its suite of services. With credible and extensive research backing Cannabix's technology, including validation studies demonstrating its efficacy, Omega Laboratories is confident in the reliability and accuracy of the THC breathalyzer. In partnership with Cannabix, Omega will be performing a full validation study to further demonstrate the effectiveness of the breathalyzer technology in real-world testing scenarios, ensuring unparalleled accuracy and reliability for clients.
"At Cannabix Technologies, we are thrilled to partner with Omega Laboratories, a company that upholds a tradition of excellence in drug testing, backed by their extensive accreditations and certifications,", stated, Rav Mlait, CEO of Cannabix Technologies Inc. "This partnership further solidifies our commitment to providing trusted and highly accredited solutions, offering unparalleled expertise and reliability to our clients."
The integration of Cannabix's THC breathalyzer technology into Omega Laboratories' testing protocols will enable rapid and precise detec&shy;&shy;tion of THC levels in breath samples. This innovative approach not only streamlines the testing process but also ensures reliable results for clients across various industries, including law enforcement, workplace safety, and healthcare.
Furthermore, as part of this collaboration, all breathalyzer samples analyzed by Omega Laboratories will undergo rigorous testing using mass spectrometry (mass spec), a gold standard in analytical chemistry. This meticulous approach reinforces Omega's commitment to delivering accurate and reliable results, maintaining the highest standards of quality and integrity.
With the rise in cannabis legalization, employers face new challenges. Traditional cannabis testing methods, such as oral fluid, urine, and hair tests, can detect cannabis use for extended periods, ranging from days to months. However, utilizing the Cannabix breathalyzer to test breath for cannabis isolates THC detection to just a few hours after use.
"Our partnership with Cannabix Technologies underscores our commitment to staying at the forefront of advancements in drug testing technology," said Bill Corl, CEO of Omega Laboratories. "By incorporating their groundbreaking THC breathalyzer technology, we are poised to enhance the accuracy, efficiency, and accessibility of cannabis testing."
With this strategic partnership, Omega Laboratories and Cannabix Technologies are poised to drive innovation and set new standards in cannabis testing, ensuring safer communities and workplaces.
For additional information on these solutions, please contact Omega at 1-800-665-5569 or&nbsp;sales@omegalabs.net.
&nbsp;
Cannabix News Updates:
July 11, 2024 - <a href="https://cannabixtechnologies.com/investors/news-releases/cannabix-technologies-and-omega-laboratories-inc-provide-positive-developments-on-marijuana-breathalyzer-testing/">Cannabix Technologies and Omega Laboratories Inc. Provide Positive Developments on Marijuana Breathalyzer&nbsp;Testing</a>

Omega Labs partners with Cannabix Technologies to enhance drug testing capabilities, offering advanced solutions for accurate detection of cannabis use.

Omega Laboratories Partners with Cannabix Technologies Inc. for Marijuana Breath Detection

MOGADORE, Ohio,&nbsp;May 30, 2023&nbsp;/PRNewswire/ -- Omega Laboratories ("Omega"), a leading provider of laboratory testing solutions, is proud to announce that its toxicology laboratory in Ontario, Canada, has been awarded ISO 17025 accreditation. This significant achievement highlights Omega Laboratories&rsquo; commitment to maintaining the highest standards of quality and precision in its operations.
ISO/IEC 17025 is an internationally recognized standard for the competence of testing and calibration laboratories. The accreditation demonstrates the Omega Laboratories&rsquo; Ontario laboratory meets stringent guidelines and standards set by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). The rigorous assessment process ensures that Omega Laboratories has the technical competence and management system in place to consistently deliver accurate and reliable test results.
By achieving ISO accreditation, Omega Laboratories opens the door to new opportunities and reaffirms its commitment to its existing clients. The accreditation also brings Omega in line with the Canadian Model
for Providing Safe Workplace Guidelines, a best practice guide from the Construction Owners Association
of Alberta and Energy Safety Canada. It provides clients with the assurance that their samples will be handled and analyzed by a laboratory that adheres to one of the highest industry standards.
&ldquo;The ISO 17025 accreditation is another significant milestone for Omega Laboratories,&rdquo; said Jerry Crosby, President. &ldquo;We are extremely proud of our team&rsquo;s hard work and dedication and look forward to providing future announcements as Omega continues to expand operations and services to meet our clients&rsquo; needs not only in Canada, but globally as well.
To obtain ISO 17025 accreditation, Omega Laboratories underwent a comprehensive evaluation process, which included an assessment of its quality management system, technical competence, and proficiency in conducting specific tests. The laboratory had to demonstrate compliance with a wide range of criteria, including instrument calibration, quality control staff competency, and the traceability of measurements.
For additional information on these solutions, please contact Omega at 1-800-665-5569 or&nbsp;sales@omegalabs.net

Omega Laboratories Achieves ISO 17025 Accreditation at Ontario, Canada Laboratory

MOGADORE, Ohio, December 22, 2022 /PRNewswire/ -- Omega Laboratories ("Omega"), a leading provider of laboratory testing solutions, is proud to announce the launch of Urine Drugs of Abuse testing services in its state-of-the-art laboratory in Ontario, Canada. The laboratory will begin offering Urine Drug Testing on January 3, 2023, to complement its molecular testing.
Omega has led the Canadian molecular testing market in turnaround times by consistently reporting results within an average of five to six hours while maintaining a high level of quality. The company has been serving Canada for two years since the opening of laboratories in British Columbia (BC) and Ontario at the height of the COVID-19 pandemic. Omega continues to provide the much-needed turnaround time requirement for PCR testing in BC for travel to China and the film production industry.
The expansion of toxicology services in Canada will offer clients an alternative to the limited testing options available in Canada.&nbsp; The operations are backed by Omega's twenty-two years of high-quality standards and fast turnaround time of results from its US operation. The laboratory is in the final process of adding toxicology to its existing ISO/IEC 15189 accreditation, which provides both proof of quality and expertise to regulatory authorities worldwide.&nbsp;&nbsp;
Omega Canada will be offering drug testing panels specifically tailored to the needs of the market while also offering significantly decreased turnaround times due to its locations in Canada. "We are excited to continue to expand our test menu in Canada," said Jerry Crosby, President, Omega Laboratories. "The Ontario laboratory will allow Omega to facilitate quality urine drug testing solutions not only for Canada, but for its global clients as well. The laboratory is powered by the same standard processes, quality of service and technology solutions that Omega is known for around the world."
These global technology solutions include the Online Custody &amp; Control Form (oCCF). The oCCF makes it easy to track and manage both instant and laboratory-based test results and to share data across different regions in real time. These products are already in use by multi-national organizations that need to meet stringent regional data privacy and accreditation standards. The oCCF is available in over six languages and can be data integrated with other systems.
For additional information on these solutions, please contact Omega at 1-800-665-5569 or&nbsp;sales@omegalabs.net
<div class="mx-2 px-4 py-4 text-center mb-4 justify-center location-card">
<div class="text-center font-bold">Omega - British Columbia</div>
<div class="">42 Fawcett Road, Unit 110</div>
<div class="">Coquitlam,&nbsp;BC&nbsp;V3K 6X9&nbsp;Canada</div>
<div class="">Telephone:&nbsp;+1.604.554.1228</div>
<div class="">Email:&nbsp;customerservice@omegalabs.net</div>
</div>
<div class="mx-2 px-4 py-4 text-center mb-4 justify-center location-card">
<div class="text-center font-bold">&nbsp;</div>
<div class="text-center font-bold">Omega - Ontario</div>
<div class="">2150 Dunwin Drive, Unit 1 &amp; 2</div>
<div class="">Mississauga,&nbsp;ON&nbsp;L5L 5M8&nbsp;Canada</div>
<div class="">Telephone:&nbsp;+1.289.919.3188</div>
<div class="">Email:&nbsp;customerservice@omegalabs.net</div>
</div>

Omega Laboratories is proud to announce the launch of Urine Drugs of Abuse testing services in its state-of-the-art laboratory in Ontario, Canada.

Omega Laboratories, Inc. Announces Launch of Urine Drugs of Abuse Testing in Ontario, Canada

Omega Laboratories is honored to have participated in a meeting organized by the Institute for Safe Traffic Technologies&nbsp; and the Brazilian mission hosted at the United Nations in New York to discuss the rapidly growing success of hair drug testing in Brazil. This meeting, which included the presentation of both Brazilian and US statistics, demonstrated the impressive capabilities of hair testing for drugs of abuse, especially in the transportation industry.&nbsp; This event was attended by a large number of transportation and drug testing industry experts, including Brazil&rsquo;s former President Fernando Henrique Cardoso&cedil; Director of the National Department of Transit (DENATRAN) Maur&iacute;cio Alves. Two years ago, Brazil implemented a law that required professional drivers pass a hair drug test before receiving or renewing their commercial licenses. According to the Brazilian Federal Highway Police, this change &ldquo;contributed to a 38% drop in the number of fatal accidents involving trucks on Brazilian federal highways in just the first six months of the requirement.&rdquo; Furthermore, the data shows that the implementation of this program has also dissuaded a large number of drug users from applying for C, D and E class licenses.&nbsp; &nbsp;The former President of Brasil addressed the importance of hair testing, stating "We must continue to move forward in this process of modernization. What we are seeing is the implementation of a policy based on technological advances that ensure the public's health and safety." Omega Laboratories is honored that their Brazilian testing data&nbsp; was discussed during the presentations and is confident that this continued success for hair testing will lead companies, industries, and countries to recognize and choose hair testing as the superior drug testing method.&nbsp;

Omega Laboratories is honored to have participated in a meeting organized by the Institute for Safe Traffic Technologies  and the Brazilian mission hosted at the United Nations in New York to discuss the rapidly growing success of hair drug testing in Brazil.

Omega Laboratories Attends United Nations Meeting on Hair Drug Testing

MOGADORE, Ohio, May 15, 2018 /PRNewswire/ -- Omega Laboratories is proud to introduce the Omega Hair 17-panel drug test, the most comprehensive hair test ever offered. This new offering tests for 45 different substances, helping safety-sensitive employers to proactively address the growing epidemic of hard drug use around the globe. This exciting new panel, which will be available starting on June 4th, 2018, will offer the detection of a much wider class of drugs of abuse, including Benzodiazepines, Barbiturates, Fentanyl, Tramadol and Ketamine.
Omega's new Hair 17-panel is the largest hair test on the market to utilize proven ELISA screening technology, developed from the same process for which Omega has been granted a number of 510(k) clearances from the U.S. Food and Drug Administration (FDA). This means that employers, government agencies and other entities can now expand their drug testing programs while still benefitting from the assurance provided by Omega's industry-leading credentials.&nbsp;
This new panel offers testing for a total of 45 different substances, including 8 commonly abused variants of Benzodiazepines. The test has been specifically designed to address the current growing trends in workplace drug abuse, including the rise of Fentanyl and prescription opiate abuse as well as the introduction of Ketamine from outside of&nbsp;the United States.
"Hair testing is a lifestyle test, showing an approximate 90-day window of usage," said&nbsp;Bill Corl, Omega's CEO. "This makes hair testing the perfect tool to identify if someone is at risk of becoming another statistic in this growing epidemic."
This new panel uses a proprietary screening method which allows Omega to screen for 17+ drug classes using only 12.5 mg of hair. This new method helps Omega to maintain their reputation as the most innovative forensic hair testing laboratory. Like all of Omega's proven hair testing, confirmations are performed using Mass Spectrometry methods, such as GC/MS/MS, and LC/MS/MS technology.
"This is not the first time Omega has chosen to innovate ahead of our competitors," said&nbsp;John Vitullo, Omega's Chairman. "We understand that the needs of the global drug testing markets are continually changing and we are here to lead that advancement."
The drugs included in the screen are Amphetamines, Methamphetamines, Cocaine, Marijuana, Opiates, Synthetic Opiates, Fentanyl, PCP, Benzodiazepines, Barbiturates, Methadone, Propoxyphene, Meperidine, Tramadol, Ketamine, Buprenorphine and Zolpidem. For additional information and cutoff levels, please contact Omega at 1-800-655-5569 or&nbsp;<a href="mailto:sales@omegalabs.net" target="_blank" rel="nofollow noopener">sales@omegalabs.net</a>.

Omega Laboratories is proud to introduce the Omega Hair 17-panel drug test, the most comprehensive hair test ever offered. This new offering tests for 45 different substances, helping safety-sensitive employers to proactively address the growing epidemic of hard drug use around the globe.

Omega Laboratories Announces Groundbreaking 17-panel Hair Drug Test to Help Organizations Tackle Drug Epidemic

MOGADORE, Ohio,&nbsp;Oct. 4, 2022&nbsp;/PRNewswire/ -- Omega Laboratories ("Omega"), a leading provider of laboratory testing solutions, announced the acquisition of Acumium, a leading technology and software development firm. This partnership further enhances Omega's ability to provide the highest level of risk mitigation while also providing more timely results for faster clinical, court and employment decisions.

Acumium is a&nbsp;Madison, WI&nbsp;based information technology firm with over 21 years of experience specializing in software development, data privacy &amp; protection, cloud computing, and managed IT services. Acumium's primary goal is to develop and tailor technology solutions that solve problems.
Omega Technology Solutions' suite of tools currently includes the oCCF (Online Custody &amp; Control Form), data integration capabilities, secure reporting services, Medical Review Officer Module, and LIMS (Laboratory Information Management Systems). These products are already in use by multinational organizations that need to meet stringent regional data and accreditation standards.
Omega has long been the leader in quality laboratory testing solutions with fast turnaround times. Omega has worked with Acumium for over 15 years to create applications that facilitate accuracy, data security and data privacy from the initial collection request through laboratory processing to result reporting and statistical analysis. These applications have become a core part of Omega's full laboratory solutions. Omega acquired Acumium to merge the industry's best laboratory team with the most advanced technology solutions team. Omega can now continue to refine these systems, which will improve every step of the testing process for our clients. Some of these solutions are already being used by other firms through license or under a Software as a Service (SaaS) agreements. The Acumium Team will easily be able to support and promote the long-standing Omega solutions with their long-standing software solutions portfolio.
"The oCCF system is an example of a successful collaboration between Omega and Acumium in recent years," said&nbsp;Bill Corl, Omega's CEO. "This system is available in multiple languages, can be utilized on a tablet or a desktop, and manages both laboratory-based testing and point of collection testing."
For additional information on these solutions, please contact Omega at 1-800-655-5569 or&nbsp;<a href="mailto:sales@omegalabs.net" target="_blank" rel="nofollow noopener">sales@omegalabs.net</a>.

Omega Laboratories ("Omega"), a leading provider of laboratory testing solutions, announced the acquisition of Acumium, a leading technology and software development firm. This partnership further enhances Omega's ability to provide the highest level of risk mitigation while also providing more timely results for faster clinical, court and employment decisions.

Omega Laboratories Acquires Acumium to form Omega Technology Solutions

CLEVELAND, Ohio, USA,&nbsp;Aug. 4, 2014&nbsp;/PRNewswire/ --&nbsp;Omega Laboratories, Inc. unveiled their newly completed laboratory expansion today, a project undertaken in response to the increasing global demand for testing drugs of abuse in hair.&nbsp;With an investment of&nbsp;5 million USD, Omega's US-based headquarters now consists of over 44,000 square feet which quadruples Omega's daily testing capacity. The new addition has been outfitted with state of the art mass spectrometry equipment and staffed by Omega's highly experienced personnel.
Omega attributes its impressive growth to many factors, including having the fastest testing turnaround time in the industry, consistently reporting results within 24-72 hours while maintaining a high level of accuracy. The turnaround time is a result of proprietary testing methods, part of the intellectual property and operating efficiencies developed by Omega over the last 14 years. This includes a specimen wash process which has been approved by multiple accrediting agencies as an effective means for removing external contamination. Omega is one of only three hair testing laboratories worldwide to have obtained FDA 510(k) clearances.
Omega has also earned a respected position within the global scientific community by providing consistent fact-based assistance and supporting the standardization for hair testing globally. The United Nations Office on Drugs and Crime recently sought Omega's expertise in reviewing the latest&nbsp;Guidelines for Testing Drugs under International Control in Hair, Sweat and Oral Fluid. This respected position has been earned, as Omega has spent years participating in meetings with government agencies, political advisors, and decision-making committees, including over forty meetings with members of the United States Congress. Because of these efforts, Omega has become the preferred expert in regulatory affairs.
Omega's hair and oral fluid testing offer numerous benefits over urine testing for clients worldwide, including identifying more drug users, tests that are harder to evade, and samples which are easier to collect and ship.
About Omega Laboratories, Inc. - Omega is a state-of-the-art laboratory providing hair and oral fluid testing for drugs of abuse to over 6,000 clients worldwide. Omega is accredited to ISO/IEC 17025 standards through Forensic Quality Services (FQS), holds a College of American Pathologists (CAP) Accreditation for Forensic Drug Testing, and 510(k) clearances from the FDA. Omega's reputation for performing accurate, timely and cost effective testing, coupled with a reputation for outstanding client service, has positioned Omega as the leader in hair drug testing.

Omega Laboratories, Inc. unveiled their newly completed laboratory expansion today, a project undertaken in response to the increasing global demand for testing drugs of abuse in hair. With an investment of 5 million USD, Omega's US-based headquarters now consists of over 44,000 square feet which quadruples Omega's daily testing capacity.

Omega Laboratories Quadruples Hair Drug Testing Capabilities

MOGADORE, Ohio, June 13, 2012 /PRNewswire/ -- Omega Laboratories, Inc. recognizes and applauds yesterday's announcement that the remaining laboratory of those accredited by the College of American Pathologists (CAP) for forensic hair drug testing has decided to utilize Enzyme Immunoassay technology. This announcement comes after a decade of disagreement and confusion regarding differing methodologies and proprietary techniques. This change could signal that the hair testing industry has finally come to a consensus on the superiority of Enzyme Immunoassay technology as a screening method for drugs of abuse.
This announcement represents a unity of methodology within the hair testing industry, as all three major workplace hair testing laboratories now use EIA as their screening method of choice. Omega anticipates that this harmonization on screening methodologies will aid in the acceptance of hair testing by the Substance Abuse and Mental Health Services Administration (SAMHSA) and their Drug Testing Advisory Board (DTAB).
Omega Laboratories has chosen to use Enzyme Immunoassay (EIA) technology since its inception in 2000, citing superior accuracy, reliability, and low impact upon the environment. Omega's use of EIA for 12 years has contributed to its position as a leader in the hair testing industry, allowing Omega to be an active and successful participant in worldwide proficiency testing programs. In addition, it has aided Omega in securing prestigious international accreditations and Food and Drug Administration (FDA) clearances for the company's screening assays.
Enzyme Immunoassay (EIA) is a quick and cost effective biochemistry assay used to identify the presence of substances within specimens. When used for drugs of abuse screening, this technology allows laboratories to efficiently and accurately detect drugs of abuse in hair specimens, which can then be confirmed through GC/MS and LC/MS technology. Since the 1992 publication of a World Health Organization study, which highlights the benefits of EIA technology, EIA has become the prevailing method of choice worldwide.
A common predecessor of EIA is Radioimmunoassay (RIA), which uses radioactive signal to detect substances within a sample. Some members of the hair testing for drugs of abuse industry have continued to market the use of RIA technology, despite widespread knowledge that this practice creates radioactive waste, which raises environmental concerns.
"It is exciting to hear that another laboratory has joined Omega in using Enzyme Immunoassay technology," said Dr. John Vitullo, CEO of Omega Laboratories. "We have used this technology at Omega for over 12 years with great success and we know that the adoption of EIA by our competitors will not only be better for the environment, but will also help to establish equivalence and convergence in hair testing results across different laboratories."
In addition to numerous international accreditations, Omega Laboratories has utilized EIA to receive FDA screening assay clearances for its Cocaine, Methamphetamine, PCP, and Opiates panels, and is the only hair testing laboratory to have documented clearance for Codeine, Oxycodone and Hydrocodone testing.

Omega Laboratories, Inc. recognizes and applauds yesterday's announcement that the remaining laboratory of those accredited by the College of American Pathologists (CAP) for forensic hair drug testing has decided to utilize Enzyme Immunoassay technology. This announcement comes after a decade of disagreement and confusion regarding differing methodologies and proprietary techniques. This change could signal that the hair testing industry has finally come to a consensus on the superiority of Enzyme Immunoassay technology as a screening method for drugs of abuse.

Omega Laboratories Applauds the Adoption of Enzyme Immunoassay (EIA) by Major Hair Testing Laboratories

SALT LAKE CITY, April 26, 2011 /PRNewswire/ -- C.R. England, a Salt Lake City-based global transportation provider, and Omega Laboratories, Inc. a state-of-the art drug testing facility, have announced an innovative drug screening partnership that will test the hair samples of driver applicants. This program will enhance England's preemployment drug screening process with the end result of putting safer drivers on the road.
"The industry-wide impact of being able to conduct a pre-employment drug test that reviews a longer screening history is a tremendous improvement over the current Federally mandated requirements," said Dustin England, Vice President of Safety and Compliance for C.R. England. "With hair testing, we are able to detect months of time rather than the handful of days checked with standard urine tests. We found our hair testing positive rate was over three times higher than the required DOT urine test alone."
During the trial, both urine and hair samples were collected. After a year of research, the management team at C.R. England became convinced that hair testing was a superior methodology for pre-employment drug screening and offered a much more effective screening process than urine testing. England will continue to conduct standard urine drug testing for all applicants as required by the DOT.
Results of the trial program clearly show its effectiveness. Out of 2,000 candidates, over 150 tested positive that would have otherwise passed the current Federally-mandated testing. In total, over 11 percent tested positive with hair resting, versus 2.8 percent testing positive with DOT urine testing.
In addition to being a leader in the refrigerated trucking industry, C.R. England operates four driving schools across the United States. "By operating our own schools, we can provide the best training for our future professional truck drivers and their safety," England says. "By hair testing we can better control the quality of successful applicants. Knowing we can keep more potentially dangerous drivers off the roads is a great feeling," continues England. "That is why we are now firm believers in the benefits of hair testing for the transportation industry."
About C.R. England, Inc.: Founded in 1920 with corporate headquarters in Salt Lake City, C.R. England, Inc. is one of North America's largest transportation companies and the world's largest temperature-controlled carrier. C.R. England services include National, Mexico and Regional Truckload service in addition to Dedicated and Intermodal services. Additional services include Leasing, Brokerage, LTL/Parcel, Supply Chain Engineering, Special Project Engineering, Warehousing, and Global Sourcing, which includes offices in Southern California and China. For more information, visit <a title="Learn more about C.R. England" href="https://www.crengland.com/" target="_blank" rel="noopener">www.crengland.com</a>.

C.R. England, a Salt Lake City-based global transportation provider, and Omega Laboratories, Inc. a state-of-the art drug testing facility, have announced an innovative drug screening partnership that will test the hair samples of driver applicants. This program will enhance England's preemployment drug screening process with the end result of putting safer drivers on the road.

C.R. England Improves Safety With Innovative Approach to Applicant Screening

MOGADORE, Ohio, July 23, 2013 /PRNewswire/ -- Omega Laboratories, Inc. is pleased to announce that it is assisting the Drug Testing Advisory Board (DTAB) with the evaluation of hair specimens for use in the Federal Workplace Drug Testing Program. Recent concerns and data have emerged which challenge the effectiveness of traditional urine-based testing. As a result, the DTAB assembled authorities from across the drugs of abuse testing industry, including Omega's Laboratory Director Dr. David Engelhart, at its July meeting in order to thoroughly explore the testing of hair specimens as a valuable and long-needed addition to the Federal Workplace Drug Testing Program.
During the July 15th DTAB meeting in Rockville, Maryland, members were given presentations by highly-recognized authorities in the drug testing industry, including the laboratory directors from the three largest United States based workplace hair testing laboratories. Dr. David Engelhart of Omega Laboratories confirmed the proven scientific reproducibility of hair testing, stating that "proficiency testing has shown consistent results of the hair testing screening processes across multiple laboratories worldwide."
Public comments at this meeting mirrored those from other DTAB meetings over the last several years, which strongly favored the addition of hair as a specimen for testing. Five-years of dual testing data from the trucking industry, which included over 200,000 DOT driver candidates from more than 25 different motor carriers, demonstrates that urine testing by itself is no longer effective for pre-employment screening. Industry experts in attendance noted the availability of existing qualifications for testing laboratories, including accreditation by the College of American Pathologists (CAP) and the internationally accepted ISO/IEC 17025 standard, as well as the thorough review and clearances already granted by the Food and Drug Administration (FDA), another agency within Health and Human Services (HHS). The fact that the three main workplace hair testing laboratories have achieved equivalent levels of accreditation and participate in a robust international proficiency testing program should lead to swift and simple acceptance.
Since 1988, organizations that are required to perform Federal Workplace Drug Testing have been limited to the use of urine specimens. Many motor carriers have chosen to go above and beyond the federal requirements and have added hair testing to ensure that they are screening out potentially dangerous employees. This comes at a cost, as these companies are still required to pay for the currently mandated urine testing as well. Hair specimen testing provides a significantly longer detection window, is very difficult to adulterate, and eliminates collection issues associated with urine. As a result, hair testing has consistently identified over three times as many illegal substance users as urine testing in regulated industry pre-employment trial programs. Regulated industries in other countries, including airlines and government agencies, have already had improved success with both hair and laboratory-based oral fluid testing.
The DTAB is an advisory committee for the Substance Abuse and Mental Health Services Administration (SAMHSA), who established the board to "improve the quality of systems for drug testing." The decision to evaluate hair testing comes only eighteen months after the DTAB fast-tracked the review of laboratory-based oral fluid testing which also offers many advantages over traditional testing methods.
"We feel that the acceptance of both hair and laboratory-based oral fluid testing by SAMHSA will be a key factor in maintaining the United States drug testing program's position as the true 'gold standard,'" states Bill Corl, CEO of Omega Laboratories.
About Omega Laboratories, Inc. - Omega Laboratories, Inc. is a state-of-the-art facility providing laboratory-based hair and oral fluid testing for drugs of abuse to over 5,000 clients worldwide. Omega currently holds CAP Forensic Drug Testing accreditation, is accredited to ISO/IEC 17025 standards, and has obtained screening clearances from the FDA. Omega's reputation for performing accurate, timely and cost effective testing, coupled with an unmatched reputation for client service, has positioned Omega as the leader in the alternative specimen drug testing industry.

Omega Laboratories, Inc. is pleased to announce that it is assisting the Drug Testing Advisory Board (DTAB) with the evaluation of hair specimens for use in the Federal Workplace Drug Testing Program. Recent concerns and data have emerged which challenge the effectiveness of traditional urine-based testing. As a result, the DTAB assembled authorities from across the drugs of abuse testing industry, including Omega's Laboratory Director Dr. David Engelhart, at its July meeting in order to thoroughly explore the testing of hair specimens as a valuable and long-needed addition to the Federal Workplace Drug Testing Program. 

Omega Laboratories Presents Data on Hair Specimens for Federal Workplace Drug Testing Program

PACIFIC, Wash.,&nbsp;Sept. 20, 2011&nbsp;/PRNewswire/ -- Gordon Trucking, one of the nation's most reliable truckload carriers, has begun drug screening all applicants via hair samples with the goal of reducing new driver accidents within the first crucial months of employment. &nbsp;Gordon joins a growing list of carriers that perform hair testing under company authority to supplement the minimum DOT mandated urine testing requirements. &nbsp;
"Research has shown most accidents occur within the first 90-120 days of employment," states&nbsp;Scott Manthey, Vice President of Safety and Compliance for Gordon Trucking. &nbsp;"Once a driver makes it through that initial period the risk of an accident drops dramatically. &nbsp;We feel that a urine test combined with the longer timeframe of a hair test offers one the best possible screening tools. We have concluded that this aids in selecting some of the safest and most professional drivers on the road."
The program started in&nbsp;July 2011&nbsp;with Omega Laboratories, Inc. and has already shown beneficial results. &nbsp;Of the 170 drivers already screened, hair testing has detected 10 positive candidates that would have otherwise been hired. &nbsp;"Beyond the candidates who have tested positive," adds Manthey, "we also routinely have candidates dismiss themselves from orientation classes once they confirm a hair test will be conducted." &nbsp;
Safety-conscious carriers like Gordon Trucking not only follow minimum federal requirements, but often choose to utilize new advances in technology. &nbsp;Once such innovations are proven to be effective, they are often incorporated into future federal policy. &nbsp;Hair testing is just one example of motor carriers raising the bar on safety. &nbsp;Other examples of optional policies under company authority currently include drug testing for extended opiates, use of Electronic On-Board Data Recorders, and sleep apnea screening.
"After considerable research, Gordon Trucking concluded that it was our responsibility to raise the bar for driver screening ," states Manthey. &nbsp;
"While the spread of dual DOT urine and hair testing programs is encouraging, additional reforms need to be implemented as well. &nbsp;The proposals for a 'Drug Test Clearinghouse' should be expanded to include any drug or alcohol screen that has been medically reviewed, not just those tests mandated by the DOT," asserts Manthey. &nbsp;"Additional training should also be stipulated for all Medical Review Officers and physicians involved in the screening process."
"Professional, responsible drivers are a carrier's best asset," summarizes Manthey. &nbsp;"Removing controlled substance abusers from the commercial motor vehicle is a critical part of improving the safety of America's highways. "
About Gordon Trucking Inc.:&nbsp;&nbsp;With over&nbsp;2500 employees and 1900 trucks, Gordon Trucking is the 22nd largest truckload carrier in&nbsp;North America&nbsp;and the 64th largest for-hire carrier overall. &nbsp;Gordon Trucking offers local, regional and trans-continental truckload services within&nbsp;the United States&nbsp;and to and from&nbsp;Canada&nbsp;including temperature control and regional heavy haul service. &nbsp;For more information, visit&nbsp;<a title="Learn more about Gordon Trucking Inc" href="http://www.gordontrucking.com/" target="_blank" rel="noopener">www.gordontrucking.com</a>.

Gordon Trucking, one of the nation’s most reliable truckload carriers, has begun drug screening all applicants via hair samples with the goal of reducing new driver accidents within the first crucial months of employment.  Gordon joins a growing list of carriers that perform hair testing under company authority to supplement the minimum DOT mandated urine testing requirements.  

Gordon Trucking Implements Hair Testing With Goal of Reducing New Driver Accidents

MOGADORE, Ohio, September 21, 2010 /PRNewswire/ -- Omega Laboratories, Inc. today announced that it has received accreditation for forensic drug testing of hair from the Commission on Laboratory Accreditation of the College of American Pathologists (CAP). During the CAP accreditation process, inspectors carefully review the laboratory&rsquo;s records and quality control procedures for the preceding two years, as well as the laboratory&rsquo;s equipment, facilities, safety program and record. CAP inspectors also examine laboratory staff qualifications and the overall management of the laboratory. This stringent inspection program is designed to ensure the highest standard of care for all laboratory clients. Omega Laboratories is only one of two laboratories in the world to receive this prestigious accreditation for drug testing in hair.
&ldquo;In the past Omega has received accreditation from CAP for urine testing, but we have shifted our focus to utilize our expertise in hair testing,&rdquo; said Dr. John Vitullo, CEO of Omega Laboratories. &ldquo;We were pleased to see CAP has responded to the increasing demand for hair testing and added it to its accreditation program. This accreditation is one more way Omega maintains its position as an industry leader.&rdquo;
&ldquo;We are especially proud of the CAP accreditation,&rdquo; continues Dr. Vitullo, &ldquo;because it specifically covers all facets of the hair testing laboratory procedure, including screening, extraction and confirmation.&rdquo; This detailed examination of the testing process also included a complete review of Omega&rsquo;s hair wash procedure for removing external contaminants.
The addition of CAP accreditation further positions Omega Laboratories as a worldwide leader in hair testing for drugs of abuse. Omega&rsquo;s qualifications include:
<ul>
<li>ISO/IEC 17025 Laboratory Accreditation &ndash; Currently the only drugs of abuse laboratory in the United States with this accreditation.</li>
<li>ISO/IEC 17025 Forensic Quality Services (FQS) &ndash; Special designation for forensic/court testing.</li>
<li>FDA Clearance &ndash; Proven capability to obtain voluntary clearance of screening assays.</li>
<li>Certification by other industry groups such as CLIA and New York State Department of Health.</li>
<li>Proficiency Testing &ndash; Participation in Society of Hair Testing (SOFT), German Society of Toxicological and Forensic Chemistry (GTFCh) hair testing proficiency programs.</li>
</ul>
About CAP - The College of American Pathologists is a medical society that serves more than 17,000 physician members and the laboratory community throughout the world. It is the world's largest association composed exclusively of Board-certified pathologists and is widely considered the leader in laboratory quality assurance. The College is an advocate for high-quality and cost-effective patient care. More information about the College can be found at www.cap.org.

Omega Laboratories, Inc. today announced that it has received accreditation for forensic drug testing of hair from the Commission on Laboratory Accreditation of the College of American Pathologists (CAP).

Omega Laboratories Awarded CAP Accreditation for Drug Testing of Hair

MOGADORE, Ohio, February 21, 2023 /PRNewswire/ -- Omega Laboratories ("Omega"), a leading provider of laboratory testing solutions, is proud to announce a new partnership with Life Diagnostics to open state-of-the-art drugs of abuse testing laboratory in the United Arab Emirates (UAE). The new laboratory will bring drugs of abuse testing to the MENA region.
&nbsp;
The laboratory will incorporate Omega&rsquo;s years of toxicology experience and its IT solutions, with the leading industry expertise of Life Diagnostics &ldquo;Life Dx.&rdquo;, UAE&rsquo;s fastest-growing diagnostics services provider. The partnership will benefit government authorities, healthcare providers, and private companies within the region by offering high-quality testing, a fast turnaround time for results, and exceptional customer service that Life Dx. has become known for in the UAE.
Life Dx. offers an extensive collection network in the region and Omega brings technical expertise to the partnership, with advanced online reporting and online multi-language custody and control form systems.
&ldquo;Omega is honored to be partnering with one of the highest quality, fastest growing diagnostic services organizations in the Region,&rdquo; said Jerry Crosby, President of Omega Laboratories, Inc. &ldquo;This partnership enables Omega to offer its clients the ability to have quality testing done in the region, saving time and cost in testing and reporting&rdquo;.&rdquo;
&nbsp;&ldquo;Life Dx. is proud to offer drugs of abuse testing through Omega Labs in our new Toxicology center in UAE,&rdquo; said Hosam Found, CEO of Life Dx. &ldquo;We believe in providing the most cost-effective and unique diagnostic services to patients and healthcare providers in the region.&rdquo;
&nbsp;This cooperative laboratory has been specifically designed to provide faster delivery options for clients in the UAE while maintaining the consistent quality that Omega and Life Dx. have become known for.

Life Diagnostics Partners with Omega Laboratories to Open a New Laboratory in UAE

Mogadore, Ohio, December 20, 2011 / PRNewswire/ -- Omega Laboratories, Inc. announced that it has become the first and only laboratory to receive 510(k) clearance from the Food and Drug Administration (FDA) for its Extended Opiates Test that detects the use of Oxycodone and Hydrocodone through human hair analysis. The clearance also included the test for Codeine, Morphine and Heroin.
The ability to test for Oxycodone (eg. OxyContin&reg; and Percocet&reg;)* and Hydrocodone (eg. Vicodin&reg; and Lortab&reg;)* has become increasingly important to organizations as prescription drug abuse continues to rise, and has been recognized as a serious and growing health problem. A recent report by the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) found that use of prescription pain relievers without a doctor's prescription, or for nonmedical use, is the second most common form of illicit drug use in the United States.
As stated at a meeting of the U.S. Department of Health and Human Service&rsquo;s Drug Testing Advisory Board (DTAB) in January of this year, the DTAB views this type of clearance as a key component in the future adoption of hair testing to Federal Workplace Drug Testing Programs. In addition, many companies regulated by Federal Guidelines, like the U.S. Department of Transportation&rsquo;s 49 CFR Part 40, have come to rely on Extended Opiates testing in hair samples because they realize prescription opiate abuse is a critical workplace safety issue. Regulated companies that have safety-sensitive positions, such as motor carriers, pipeline/energy, nuclear power and railroads, are able to conduct expanded drug testing programs under company authority and often do so because of the inherent flaws in the current urine based testing program.
&ldquo;At Omega we are focused on providing the highest-quality and most reliable testing procedure available,&rdquo; said Dr. John Vitullo, CEO of Omega Laboratories. &ldquo;This clearance means that we offer our clients an unsurpassed level of expertise and proficiency in our hair testing for drugs of abuse process. This clearance is one more way Omega maintains its position as the industry leader in testing expertise and customer service.&rdquo;
Omega&rsquo;s 510(k) FDA submission contained over 13,000 pages and included extensive studies involving precision, agreement, stability, recovery, effects of contamination, and the effects of different hair cosmetic treatments including multiple coloring products, straighteners/relaxers, and shampoos marketed to evade a drug test. Hair color, curvature and ethnic origin of the samples were also analyzed to ensure that a diverse population was represented in the studies. A shipping study was performed showing there were no effects to the hair samples from extreme temperature and humidity changes, unlike the problems that have plagued the transport of urine samples.
&ldquo;In addition to being the only hair testing laboratory with clearance for an Oxycodone and Hydrocodone test, Omega was the first hair testing laboratory in the United States accredited to the ISO/IEC 17025 standard,&rdquo; said Dr. Vitullo. &ldquo;Accrediting agencies have referred to ISO/IEC 17025 as the gold standard of laboratory accreditation, and we feel strongly that it is the most comprehensive quality process available to our industry.&rdquo;
According to the January 2009 FDA Guidance Document entitled Submission of Laboratory Packages by Accredited Laboratories, &ldquo;ISO/IEC 17025 is the most widely used laboratory standard for federal testing laboratories, including FDA&rsquo;s own laboratories, and ISO/IEC 17025 is internationally recognized and accepted world-wide."&nbsp;

Omega Laboratories, Inc. announced that it has become the first and only laboratory to receive 510(k) clearance from the Food and Drug Administration (FDA) for its Extended Opiates Test that detects the use of Oxycodone and Hydrocodone through human hair analysis. The clearance also included the test for Codeine, Morphine and Heroin.

Omega Laboratories Becomes the First Laboratory to Receive 510(k) Clearance for Oxycodone and Hydrocodone Drugs of Abuse Test for Hair

MOGADORE, Ohio, Dec. 11, 2012 /PRNewswire/ -- Omega Laboratories, Inc. announced that it has received 510(k) clearance from the Food and Drug Administration (FDA) for its Marijuana Metabolite Test, which detects the use of marijuana through human hair analysis. Omega Laboratories is one of the largest laboratories in the world performing hair testing for drugs of abuse and one of only three hair testing laboratories to have proven their capability to obtain FDA 510(k) clearances for the technology.
Omega has collaborated with Agilent Technologies to develop a highly-precise marijuana metabolite confirmation assay for the Agilent Technologies GC/MS/MS. This has enabled Omega to test at a Limit of Detection (LOD) level of 0.005 picograms per milligram of hair for the FDA submission. Additional research conducted by Omega Laboratories and Agilent Technologies has been presented at the Society of Forensic Toxicology (SOFT). This data confirms Omega's ability to reach an LOD as low as 0.002 picograms per milligram of hair for testing marijuana metabolite. "Over the last few years this collaboration with Omega has tested our GC/MS/MS product line in their production environment and we are very happy to report that the equipment maintained and continues to maintain the required precision," remarked Thomas Gluodenis, Forensics &amp; Toxicology Business Manager for Agilent Technologies.
The ability to test for Marijuana Metabolite has become increasingly important to organizations as drug abuse continues to increase and concerns grow about this serious and growing health problem. A recent report by the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) identified marijuana as the most commonly abused form of illicit drug in the United States.
As stated at a meeting of the U.S. Department of Health and Human Service's Drug Testing Advisory Board (DTAB) in January 2011, the DTAB views this type of FDA clearance as a key component in the future adoption of hair testing for Federal Workplace Drug Testing Programs. In addition, many companies regulated by Federal Guidelines (such as the U.S. Department of Transportation's 49 CFR Part 40) have come to rely on hair testing for drugs of abuse because drug abuse has become a critical workplace safety issue. Regulated companies in industries such as trucking, oil and gas, nuclear power, and railroads, are now able to conduct expanded drug testing programs for safetysensitive positions under "company authority." These companies often do so because of the inherent flaws in the current urine-based Federal testing program.
"Omega prides itself on challenging the boundaries of what a hair testing laboratory can accomplish," said Bill Corl, CEO of Omega Laboratories. "Rather than confuse the market by patenting portions of these procedures, Omega has chosen to work with companies like Agilent Technologies to promote higher standards for the detection of drugs of abuse."
The Omega 510(k) submissions were evaluated by the FDA at a much more stringent level than those submissions cleared over a decade ago. Omega's 510(k) submissions averaged over 7,000 pages in length, and included extensive studies involving precision, agreement, stability, recovery, and possible effects of contamination. Omega also researched the possible effects of different hair cosmetic treatments including multiple coloring products, straighteners/relaxers, and shampoos specifically marketed to evade a drug test. Hair color, curvature, body location (head or body), and ethnic origin of the samples were analyzed to ensure that a diverse population was represented in the studies.
In addition to having clearance for Marijuana Metabolite testing, Omega has FDA clearance for Cocaine, Methamphetamine, PCP, Opiates and is currently the only hair testing laboratory to have FDA clearance for Codeine, Oxycodone, and Hydrocodone testing.

Omega has received 510(k) clearance from the Food and Drug Administration (FDA) for its Marijuana Metabolite Test, which detects the use of marijuana through human hair analysis. The Omega 510(k) submissions were evaluated by the FDA at a much more stringent level than those submissions cleared over a decade ago.

Omega Laboratories Receives FDA 510(k) Clearance for Marijuana Metabolite (THCA) Drugs of Abuse Test Utilizing Hair and Publishes Lowest Limit of Detection

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