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FDA Grants Clearance to Startox On-Site Drug Test

June 14, 2002

Starplex Scientific Inc. and American Bio Medica Corporation (Nasdaq:ABMC) today announced that Starplex has received 510(k) clearance from the United States Food and Drug Administration (FDA) for Startox(TM), an on-site point of care assay capable of detecting illicit drug abuse within five minutes.

Startox is a completely self-contained sample collection and analysis device designed to minimize specimen handling. The test detects the presence of cocaine, opiates, THC, PCP, and amphetamines simultaneously. Both Starplex and ABMC view Startox as a breakthrough in cup-based on-site drug testing, because the test utilizes a patented leak-resistant design and delivers performance reliability comparable to laboratory standards.

Employing a sample cup designed by Starplex, and patented membrane strips developed by ABMC, Startox is used to collect a urine sample and then sealed, after which a clearly-viewed panel indicates positive or negative results within minutes. In the case of a positive result, the sealed device safeguards chain of custody concerns until laboratory confirmation takes place.

"FDA clearance of Startox is an important milestone in the development of a whole new line of Starplex products, and the beginning of what we hope will be a long and prosperous cooperation between Starplex and ABMC," said Fred Panini, president of Starplex Scientific. "We are already investigating other configurations of this design for the drugs of abuse market, and we ultimately hope to partner with ABMC on broader applications for on-site diagnostics."

"This product should make an immediate impact in the drugs of abuse testing market in the United States and throughout the world," noted Gerald Moore, chairman and chief executive officer of ABMC. "And we are also eager to explore the possibilities of our unique partnership with Starplex in the various arenas of on-site diagnostics."

Starplex will officially launch Startox at the 54th Annual Meeting of the American Association for Clinical Chemistry (AACC) in Orlando, Florida, July 28-August 1.

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