Medtox Scientfic (AMEX:TOX)
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MEDTOX Scientific, Inc. (AMEX:TOX), announced today that
it has received 510(k) clearance from the U.S. Food and Drug
Administration (FDA) to market its Sure-Screen(R) drugs-of-abuse
point-of-collection test (POCT) device.
Sure-Screen(R) is a POCT device intended to provide significantly
lower detection levels for eight commonly abused drugs. Current tests
provide detection levels that have been established by the Substance
Abuse and Mental Health Services Administration (SAMHSA), a Federal
agency that regulates certain workplace drug testing required under
Federal law. Those detection levels have been broadly adopted by both
laboratories and device makers for all drug screening. The SAMHSA
established detection levels are generally intended to deter drug
abuse and minimize litigation related to employment drug screening,
but not necessarily to detect all usage.
The Company believes there is a demand for the much lower
detection levels in certain markets that are interested in "zero
tolerance." Specific markets to which Sure-Screen(R) will be targeted
are, probation, parole, drug rehabilitation, hospital emergency
departments, physician office clinics, laboratories, and corporate
clients interested in lower detection levels for pre-employment
testing. In all of these markets there is value added in reducing the
detection level for abused drugs, and therefore increasing the number
of those detected abusing drugs.
Clinical data supports that Sure-Screen(R) will provide lower
detection levels on eight drugs (marijuana, opiates, cocaine,
amphetamines, methadone, benzodiazepines, methamphetamines, and
MDMA-Ecstasy) by an average of approximately 50% each.
Sure-Screen(R) creates a significant competitive advantage, as the
Company is currently unaware of any existing FDA cleared POCT devices
with this broad panel and low detection levels. MEDTOX Scientifics
unique structure in owning an ISO certified medical device
manufacturer and a federally certified drug testing laboratory creates
additional competitive advantages in two ways. First, Sure-Screen(R)
is a preliminary on-site screen that may require further laboratory
confirmation. MEDTOX Laboratories can provide that confirmation in a
seamless manner. Second, there are a limited number of laboratories
that are either willing or capable of confirming the low drug levels
that will be detected by Sure-Screen(R).
MEDTOX Scientific, Inc., headquartered in St. Paul, Minn., is a
provider of high quality specialized laboratory testing services and
on-site/point-of-collection (POC) devices. The company also supports
customers with complete logistics, data and program management
services. MEDTOX is a leader in providing esoteric laboratory testing
services to hospitals and laboratories nationwide. This includes both
central laboratory and bio-analytical testing for pharmaceutical
clinical trials. MEDTOX develops and manufactures diagnostic devices
for quick and economical on-site/point-of-collection analysis for
drugs-of-abuse, therapeutic drugs and biological and agricultural
toxins and provides employment drug screening and occupational health
testing. For more information see www.medtox.com.