American Bio Medica Receives FDA Clearance & is Granted Patent.
American Bio Medica Corporation (NASDAQ:ABMC) announced today that the US Food and Drug Administration (FDA) has granted the Company 510(k) clearance on its Rapid TEC4 point of collection drug screen. This is the third clearance that the Company has received related to the Rapid TEC product line. The Rapid TEC products contain one individual drug-testing strip that includes the chemistry to detect more than one class of drug. These three clearances allow ABMC to provide its clinical customers with various configurations of 2 to 14 classes of drugs of abuse.
The Company also announced that is has been granted another patent from the Canadian Intellectual Property Office. Patent Number 2,219,529, related to the Company's Rapid Drug Screen product, covers a device for the collection, testing and shipment of body fluid samples. This is the third patent granted this year to ABMC by the Canadian Intellectual Property Office. With this grant, ABMC's intellectual property portfolio for its drug of abuse testing line increases to 8 United States patents and 15 foreign patents, in addition to a number of pending patent applications both within the US and internationally.
For more information on ABMC or its drug testing products, please visit www.abmc.com.
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 point of collection tests for drugs of abuse. The Company and its worldwide distribution network target the workplace, government, corrections, clinical and educational markets. ABMC's Rapid Drug Screen, Rapid One(R), Rapid TEC and RDS(R) InCup(TM) products 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 oral fluids. ABMC has been 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 and the Company assumes no duty to update any forward-looking statements based upon actual results. 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, 2003, 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.