FDA grants CLIA waiver to American Bio Medica for drug test

American Bio Medica Corporation has announced today 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."