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FDA Grants 510-k- Clearance To ABMC's Propoxyphene Test.

Business Editors


Clearance Expands Company's Resources for Detecting Prescription Painkiller Abuse, Opens New Market Opportunities

American Bio Medica Corporation (NASDAQ: ABMC) today announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for a drug testing technology to detect propoxyphene, a common prescription painkiller that has been linked with a growing trend of illicit abuse.

Propoxyphene, which is also know by the trade name Darvon(R), is a narcotic analgesic used to treat mild to moderate pain; however, it has also been associated with a number of overdose accidents and deaths in the United States.

ABMC will make the propoxyphene test available in its Rapid One(R) single drug test format, as well as incorporating it into 10-drug Rapid Drug Screen(R) panels. This FDA clearance is a significant business benchmark for the company, according to ABMC chairman and chief executive officer Gerald A. Moore, because detection of propoxyphene is a requirement in many long-standing union contracts throughout the world, and ABMC's ability to provide an FDA-cleared propoxyphene device will allow it to compete for this business.

"It is always a major benchmark to achieve FDA clearance for a new product, and this is a significant accomplishment by ABMC's R&D team," said Moore. "But it also signals a new opportunity for our marketing efforts, and we look forward to growing our business and strengthening our position as the leading drug testing manufacturer with technologies specifically devoted to the detection of prescription painkiller abuse."

ABMC is currently the only company with FDA clearance to manufacture and market drug tests specifically for the detection of Oxycodone (OXY), another commonly abused prescription painkiller. The company is able to include OXY and propoxyphene tests on custom-configured drug testing panels that meet specific needs of clients.

For more information on ABMC drug testing products, please visit

About American Bio Medica Corporation

American Bio Medica Corporation is a biotechnology company that develops, manufactures and markets accurate, cost-effective immunoassay diagnostic test kits, including some of the world's most effective on-site drugs of abuse tests. The company and its worldwide distribution network target the workplace, government, corrections, clinical and educational markets. ABMC's Rapid Drug Screen, Rapid One, Rapid Tec(R) and Rapid Tec Cup(TM) test for the presence or absence of drugs of abuse in urine, while OralStat(R) tests for the presence or absence of drugs of abuse in saliva. ABMC was named among the 2002 Deloitte & Touche Technology Fast 500, a listing of the fastest-growing technology companies in North America.

This release may contain forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ, and such differences could be material. Such risks and uncertainties include, but are not limited to, the following: continued acceptance of the Company's products, increased levels of competition in our industry, the acceptance of new products, inherent risks associated with product development and intellectual property rights, the Company's dependence on key personnel, third party sales and suppliers. There can be no assurance that the Company will be successful in addressing such risks and uncertainties. Investors are strongly encouraged to review the section entitled "Risk Factors" in the Company's annual report on Form 10-KSB for the fiscal year ended December 31, 2002, and quarterly reports on Form 10-QSB on file with the Securities and Exchange Commission for a discussion of risks and uncertainties that could affect operating results and the market price of the Company's common shares.

Darvon is a registered trademark of Eli Lilly and Company
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Publication:Business Wire
Geographic Code:1USA
Date:May 29, 2003
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