I have talked with executives at both of these
companies. It is interesting to note that this relatively new could have an impact on the
politics of "drug" testing. These tests determine current
"intoxication" not whether the subject has used a substance in the last days,
weeks or months. This is the perfect technology to be used in "for cause"
testing. If employees have an accident, they could be tested immediately to determine if
they have recently used a forbidden substance. Certainly, this would also be the relevant
question even in the case of random testing.
This technology offers a challenge to those who claim that on the job
"drug" use it the target of their concern.
On the other hand, it will undoubtedly be used and abused by the police in testing
drivers for current marijuana use. While there is no question that there are levels of
marijuana intoxication that are incompatible with driving, the question of what that level
may be is a detail that is likely to be of little interest to the police.
It is interesting to not that this is developing just as President Clinton is proposing
a reduction in the federally acceptable level of bloodstream alcohol in drivers from .10
to .08 percent.
And now a Danish snowboarder is facing charges of driving under the influence of
cannabis and a passenger is charged with just being under the influence of cannabis.
See
Danish Olympic Snowboarder Faces Felony
Charges for Possession of 2 Grams in Nevada.
Canadian Charged with Being Under the Influence of Marijuana
February 26, 1998
Company Press Release
SOURCE: Epitope, Inc.
Epitope Announces FDA Clearance of Oral Fluid Assay For Cannabanoids (Marijuana)
BEAVERTON, Ore.,
Feb. 26
PRNewswire -- Epitope, Inc. (Nasdaq: EPTO - news) today announced that its research
partner, STC Technologies, Inc., located in Bethlehem, Pennsylvania, has received FDA
clearance for the STC Cannabanoids Micro-Plate EIA (enzyme immunoassay) for use in the
qualitative determination of cannabanoids in oral fluid collected with the OraSure® Oral
Specimen Collection Device manufactured by Epitope, Inc. This assay is intended to detect
the use of marijuana. "STC and Epitope continue to develop the full panel of products
to allow drugs-of-abuse testing in oral fluids to become a near term reality that will
benefit a variety of areas where remote collection and testing are needed," said Sam
Niedballa, Ph.D., executive vice president, research and development of STC. This
clearance related to cannabanoids is in addition to recently announced clearances for use
of OraSure to test for cocaine and methamphetamine using other STC EIAs.
Under an agreement with Epitope, STC Technologies, Inc., has developed OraSure
based-tests for cotinine, a metabolite of nicotine, and a group of drugs commonly called
the NIDA-5. The NIDA-5 includes cocaine, methamphetamine, cannabanoids (THC), opiates, and
phencyclidine (PCP). "With each clearance we are a step closer to providing those
organizations who test for drugs a convenient, cost effective, and less embarrassing
alternative to current practices while enhancing control over chain-of-custody," said
John Morgan, president and chief executive officer of Epitope.
The clearance of the oral fluid tests for cocaine, methamphetamine, and cannabanoids
are the first for the group of drugs that constitute the NIDA-5. As the final members of
the NIDA-5 are cleared, Epitope intends to market combined drugs-of-abuse panels that will
be tailored to specific market needs using a single OraSure specimen in both the United
States and internationally. Epitope holds exclusive distribution rights for the STC
OraSure-based assays outside of the United States.
In 1996, the worldwide market for laboratory-based drugs of abuse
screens was approximately $530 million, involving 35 million test panels. Over 60% of
worldwide test volume and sales revenue comes from the United States.
Use of the OraSure collection device for drug testing offers many advantages over urine
collection. OraSure specimen collection offers an economic advantage since it can be
performed in any setting, thus avoiding the need for specially prepared collection sites
necessary to prevent the adulteration of urine.
OraSure collection also provides for better chain-of-custody than urine because the
collector, without embarrassment to the subject, can observe the collection. An additional
benefit of OraSure testing is that the test result can be conclusively linked to the test
subject using DNA testing performed on the same sample used for drug screening. This
provides an accurate method for responding to legal challenges that positive drug tests
are invalid due to sample mix-up at the laboratory.
Epitope believes that drug testing performed on OraSure samples will be well received
in all segments where drug testing is currently performed. Due to the advantages listed
above, OraSure-based drug testing seems especially well suited for three testing segments
- government mandated drug testing, such as testing of transportation workers (D.O.T.),
defense contractors (D.O.D.), and other governmental contractors;
- forensic testing, including applications in the criminal justice system, law
enforcement, the courts, and probation/parole programs, and
- industrial testing for employment and drug free workplace
programs.
STC Technologies, Inc. is a privately held company that develops and markets
proprietary clinical diagnostic tests and medical devices for use in clinical labs,
physicians’ offices, and worksite testing. Since its founding in 1987, STC has twice
been named to Inc. magazine’s list of the 500 fastest growing, privately held
companies in America.
Epitope, Inc. is an Oregon based corporation that develops and markets medical
diagnostic products. Its current focus is on products that use oral fluid in the detection
of HIV infection, with emphasis in the life insurance and public health market.
SOURCE: Epitope, Inc.
Supported