FOR IMMEDIATE RELEASE: American Bio Medica Assay the First On-Site Device Cleared for Detecting Misuse of Prescription Painkiller OxyContin KINDERHOOK, N.Y. -- March 25, 2024 -- American Bio Medica Corporation (NASDAQ: ABMC) today announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for Rapid One OXY, an on-site point of care assay capable of detecting oxycodone. Oxycodone is a synthetic opiate found in commonly abused prescription painkillers, including OxyContin®. The FDA clearance allows ABMC to make the drug test available to clinical markets throughout the United States. Rapid One OXY is the first and only test of its kind capable of revealing whether or not oxycodone abuse has taken place, providing results within minutes after a patient urine sample is obtained. The Rapid One OXY test is unique in that it is designed specifically for detecting oxycodone, detecting it at a very low level, and does not detect other opiates at this level. No other generalized opiate test on the market can provide these features. ABMC chairman and chief executive officer Gerald Moore believes Rapid One OXY will make an immediate impact in combating what he calls "an alarming and rapidly growing drug abuse epidemic in America." "This on-site testing device will undoubtedly play a role in determining the scale and impact of Oxy abuse in communities throughout the country," said Moore. "This is the first scientific resource specifically available to provide definitive on-site information on whether or not oxy is a factor in suspected abuse and overdose cases. "ABMC created this product as a response to requests we received from physicians and law enforcement officials. This FDA clearance validates its reliability and performance, and we see significant market potential for Rapid One OXY." OxyContin has been linked to a recent spate of overdose deaths throughout the United States. The Drug Enforcement Administration has directly blamed OxyContin for at least 117 deaths in 31 states, and suspects the drug has played a role in at least another 179 fatalities. Often called "Billy-Bob heroin" or "hillbilly heroin," Oxy is particularly popular in rural areas, though DEA Administrator Asa Hutchinson recently warned that the problem is widening, and that the country has not yet reached the peak of the Oxy issue. Abusers of the drug often chew tablets, crush tablets into powder for snorting, or dissolve crushed powder for intravenous injection to create a powerful, heroin-like high. Oxy abuse has also been linked to a series of break-in and prescription fraud crimes. Its misuse threatens the availability of several legitimate and important pain management medications, OxyContin included. Rapid One OXY is the second major FDA product clearance ABMC has received in the past four months. In December 2001, the company's Rapid One Ecstasy assay also received 510(k) clearance from the FDA. About American Bio Medica Corporation American Bio Medica Corporation develops, manufactures and markets inexpensive, accurate, on-site drugs-of-abuse diagnostic kits, sprays and support services worldwide. The company's global distributors target the workplace, physicians, corrections, clinical, and educational markets. ABMC's Rapid Drug Screen® and OralStat6(TM) test for the presence of absence of drugs of abuse in urine and saliva, respectively, while its Drug Detector(TM) identifies minute traces of illegal drugs on surfaces. 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. Forward-looking statements in this release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements involve risk and uncertainties, including without limitation, continued acceptance of the Company's products, increased levels of competition for the Company, new products and technological changes, intellectual property rights and other risks detailed from time to time in the Company's periodic reports filed with the Securities and Exchange Commission. (a) OxyContin is a registered trademark of Purdue Pharma
Contact: American Bio Medica Corporation Stan Cipkowski, 800/227-1243 Fax: 518/758-8171 Web: www.americanbiomedica.com Email: stan@americanbiomedica.com |