KINDERHOOK, N.Y.--(BUSINESS WIRE)--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 TOX Cup, a patent pending drug screen in an all-inclusive cup platform. The clearance allows ABMC to provide the Rapid TOX Cup to customers in clinical markets.
ABMC Chief Executive Officer Stan Cipkowski stated, “The Rapid TOX Cup has already been well received in the criminal justice market as it provides accurate results in an easy-to-use format, all at a lower cost to the customer. This clearance opens up additional markets to ABMC and also allows us to market the product to those customers that want a FDA-cleared product.”
Available in multiple combinations according to the customer’s needs, the Rapid TOX Cup is an accurate, easy-to-use drug screen. The Rapid TOX Cup doesn’t require any manipulation of the device; the donor simply voids into the cup. Its wide mouth and larger cup allow for easier specimen collection. A temperature strip is affixed to the cup to ensure specimen integrity, with the option to add a specimen validity test strip. Results obtained with the Rapid TOX Cup can also be photocopied for record-keeping purposes. Its fully integrated design permits collection, testing and shipment for confirmation in one device.
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®, 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. regulatory approvals 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, 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.
Contacts
American Bio Medica Corporation Stan Cipkowski, 800-227-1243, Ext. 106 Chief Executive Officer or BPC Financial Marketing John Baldissera, 800-368-1217
