Omega Laboratories Receives FDA 510(k) Clearance for Marijuana Metabolite
(THCA) Drugs of Abuse Test Utilizing Hair and Publishes Lowest Limit of
MOGADORE, Ohio, Dec. 11, 2012
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 &
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 safety-sensitive positions under "company authority." These companies
often do so because of the inherent flaws in the current urine-based Federal
"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
About Omega Laboratories - Omega Laboratories, Inc. is a state-of-the-art
facility providing laboratory-based hair and oral fluid testing for drugs of
abuse to over 6,000 clients worldwide. 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.
CONTACT: Mark Freemal, +1-800-665-5569
SOURCE Omega Laboratories, Inc.
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