>>>>NEWS! Amex: TOX
MEDTOX Scientific Receives FDA Pre-Market Clearance For Profile(R)-II Device
ST. PAUL, Minn., July 31 /PRNewswire/ -- MEDTOX Scientific, Inc. (Amex: TOX - news) announced today that its subsidiary MEDTOX Diagnostics, Inc. received U.S. Food and Drug Administration (''FDA'') 510(k) pre-market clearance for its newest and most innovative on-site drugs of abuse testing product -- PROFILE(R)-II. The PROFILE(R)-II
device enables the client to test for the five most commonly requested drugs of abuse, cannabinoids (marijuana), cocaine, opiates, amphetamines and PCP, on a single device with a single sample in one step.
''PROFILE(R)-II will be sold as both a stand-alone product and more significantly as part of a comprehensive testing system, the PROFILE(R) Test System, utilizing the stringent standards followed by MEDTOX's federally certified drug testing laboratory. The newly developed PROFILE(R) Test System includes the PROFILE(R)-II device, trained and certified collectors/testers, a chain of custody form for each donor, split specimen collection kits, automatic laboratory (GCMS) confirmation on non-negative on-site screening
results, and centralized data management for clients' test results. This system will provide clients with the most comprehensive, legally and forensically defensible on-site screening
system available in the market place. Response from clients and focus groups continues to be extremely positive. The company expects to begin shipping the PROFILE(R)-II by September 1, 1998,'' said Richard J. Braun, MEDTOX chief executive officer.
''Currently no other company can complement a federally certified laboratory and all of its resources with its own patented and FDA cleared on-site device packaged in a high quality comprehensive system. PROFILE(R)-II and the PROFILE(R) Test System will provide added value to the market place for a price comparable to current laboratory testing. While pricing will be competitive for the customer, the Company expects to achieve gross margins more in line with medical device manufacturers, as opposed to gross
margins realized from laboratory services. The Company believes it can be a market leader in making the transition from laboratory employment drug testing to on-site screening for drugs of abuse.
''The receipt of pre-market clearance from the FDA in just 39 days from submission indicates the ability of the Company to both develop and gain FDA clearance in a timely and
cost efficient manner. We have already begun development of an expanded drugs of abuse test panel for the emergency room market. This will be a one-step device in the same
format and technology as PROFILE(R)-II. It will include certain tests that are not currently included in competitors' test panels. Our 15 years of laboratory experience with
emergency room toxicology testing provides us with significant data, knowledge and credibility to define and develop on-site devices for this market.''
MEDTOX Scientific, Inc., is headquartered in St. Paul. Through its MEDTOX Laboratories subsidiary, it is the leader in providing esoteric toxicology services to hospitals and
laboratories nationwide. This subsidiary also provides employment drug testing and occupational health testing, including biological monitoring for exposure to industrial chemicals,
heavy metals and solvents. Its MEDTOX Diagnostics subsidiary develops and manufactures diagnostic devices for quick and economical on-site analysis for drugs of abuse,
therapeutic drugs and agricultural toxins. Additionally, its diagnostics subsidiary provides contract manufacturing utilizing its patented technology and proprietary manufacturing
processes.
Note: Forward-looking statements contained in this press release are made under the Private Securities Reform Act of 1995. Actual results may differ. Certain factors that may
cause such results to differ are identified on page three of the Company's 1997 annual report on Form 10-K and incorporated herein by reference.
SOURCE: MEDTOX Scientific, Inc. |
