FDA Clears American Bio Medica's New 9 Panel Rapid Drug Screen
Wednesday January 27, 9:07 am Eastern Time
Company Press Release
FDA Clears American Bio Medica's New 9 Panel Rapid Drug Screen
ABMC's Latest On-site Test Designed for Hospital and
Physician Markets
HUDSON, N.Y.--(BW HealthWire)--Jan. 27, 1999--American Bio Medica
Corporation (NASDAQ:ABMC - news) today announced that the U.S. Food
and Drug Administration (FDA) has cleared the Company's 9 panel Rapid
Drug Screen(tm) variation for sale to clinical markets.
The Company reported that the new 9 panel test will be marketed to clinical
sectors worldwide by Abbott Laboratories (NYSE:ABT - news), a
world-leading supplier of in vitro diagnostic systems and tests with sales in
more than 130 countries.
''This represents our fourth 510 (k) clearance from the FDA,'' stated
American Bio Medica Vice President of Operations Doug Casterlin. ''The
FDA's clearance of the 9 panel Rapid Drug Screen, including tricyclic
antidepressants, demonstrates ABMC's ability to meet the industry's most
demanding scientific challenges.''
According to Company President and CEO Stan Cipkowski, ''This latest
FDA clearance confirms our ability to rapidly bring to market our expanding
line of products which are customized to meet the specific needs of sizable
substance abuse testing sectors.
''We continue to monitor the drugs of abuse testing industry very closely
in order to maintain our competitive edge by responding to emerging market
demands,'' Cipkowski added. ''In doing so we expect to further advance our
market presence and continue to enlarge our distribution network by adding
key sales channels, thus contributing to both our top and bottom line
growth.''
The 9 panel Rapid Drug Screen tests for the presence or absence of THC,
cocaine, opiates, PCP, amphetamines, benzodiazepines, methamphetamines,
barbiturates, and tricyclic antidepressants.
The ABMC Rapid Drug Screen family of products is the most secure and
flexible total on-site drugs of abuse testing system on the market. Unrivaled
for ease of use, the ABMC test generates results in five minutes and is
proven to correlate 100% with the standard laboratory screening test.
American Bio Medica Corporation develops, manufactures, and markets
inexpensive, accurate, on-site drugs of abuse diagnostic kits and support
services worldwide. The Company's global distributors target the
workplace, clinical, rehabilitation, physicians, corrections, and educational
markets. ABMC's Rapid Drug Screen is proven to correlate 100% with the
standard laboratory screening test.
Forward-looking statements in this release are made pursuant to the ''safe
harbor'' provisions of the Private Securities Litigation Reform Act of 1995.
Investors are cautioned that such forward-looking statements involve risk
and uncertainties, including without limitation, continued acceptance of the
Company's products, increased levels of competition for the Company, new
products and technological changes, the Company's dependence on
third-party suppliers, intellectual property rights, and other risks detailed
from time to time in the Company's periodic reports filed with the Securities
and Exchange Commission. |
