FDA Grants CLIA Waiver To ABMC For Its Drug Test

Main Category: Alcohol / Addiction / Illegal Drugs
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 31 Aug 2008 - 0:00 PDT

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American Bio Medica Corporation (NASDAQ:ABMC) announced that the US Food and Drug Administration (FDA) has granted CLIA waived status to the Company's Rapid TOX® point of collection drug test product line. The waiver applies to all 14 drugs that the Company currently tests for in addition to two different cut-off levels for its Opiate and Cocaine tests. CLIA waived tests are recognized by FDA to be so simple to use and so accurate that there is little risk of error. CLIA waived tests are the most widely used tests in the clinical market (hospitals and physicians), and are in-demand for occupational health and criminal justice applications.

ABMC Chief Executive Office Stan Cipkowski stated, "We have been waiting some time for this decision from the FDA and we are pleased to finally receive our CLIA waiver. The granting of the CLIA waiver is expected to greatly impact our relationship with our laboratory alliance as up until this point, the lab alliance has been obtaining CLIA waived devices from another supplier. Now that our Rapid TOX device is CLIA waived, they will be obtaining all of their urine based point of collection devices from ABMC."

Cipkowski added, "CLIA waiver also allows us to complete our negotiations with several distributors who service the physician and hospital market. We are anxious to be able to penetrate new markets with our products and this waiver opens the first door for us. I expect to see an immediate impact on sales beginning in the fourth quarter of this year and ramping up throughout 2009." Cipkowski continued, "In spite of the problems and expenses related to this in 2007, our Chief Science Officer Martin Gould and Director of Quality Assurance and Regulatory Affairs Richard Reilly have completed this first waiver well under budget in 2008. We expect future waiver applications to be more cost effective and expedient due to their efforts."

For more information on ABMC or its drug testing products, please visit http://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®, Rapid TEC®, RDS® InCup®, Rapid TOX and Rapid TOX Cup® products test for the presence or absence of drugs of abuse in urine, while OralStat® and Rapid STAT™ tests for the presence or absence of drugs of abuse in oral fluids. ABMC's Rapid Reader® is a compact, portable device that, when connected to any computer, interprets the results of an ABMC drug screen, and sends the results to a data management system, enabling the test administrator to easily manage their drug testing program.

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, and 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, 2007, 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.

American Bio Medica Corporation