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FDA Grants Clearance to Startox On-Site Drug Test.


Business and Health Editors

ETOBICOKE, Ontario--(BUSINESS WIRE)--June 13, 2002

Developed by Starplex Scientific with American Bio Medica

Corporation, Integrated Collection and Testing Device

Yields Results in Five Minutes

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.

About Starplex Scientific

Starplex Scientific is headquartered in Etobicoke, Ontario, Canada. The company specializes in developing innovative, premium quality plastic disposables; providing reliable specimen transportation for many facets of the health care industry. Starplex Scientific has evolved into a prominent supplier to the medical industry, serving the needs of literally thousands of hospitals, laboratories, and health care facilities, with sales and distribution coverage in every state and province in North America.

About American Bio Medica Corporation

American Bio Medica Corporation develops, manufactures and markets inexpensive, accurate, onsite drugs-of-abuse diagnostic kits and support services worldwide. The Company and its worldwide distribution network target the workplace, government, corrections, clinical and educational markets. ABMC's Rapid Drug Screen(R), Rapid One(TM) and Rapid Tec(TM) test for the presence or absence of drugs of abuse in urine, while its OralStat6(TM) tests for the presence or absence of drugs of abuse in saliva. ABMC was recently listed among the top ten biotechnology companies on the Deloitte & Touche 2001 Technology Fast 500, a ranking of the fastest growing 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 transition period ended December 31, 2001, 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.
COPYRIGHT 2002 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2002, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Comment:FDA Grants Clearance to Startox On-Site Drug Test.
Publication:Business Wire
Geographic Code:1USA
Date:Jun 13, 2002
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