The Americal Bio Medica Corporation (ABMC) has recently made public the CLIA waived status of their Rapid TOX® product line, which includes point-of-collection drug tests for 14 drugs as well as two cut-off levels for opiate and cocaine tests.
Drug tests are often conducted by or under supervision of Food and Drug Administration. The FDA, however can give out Clinical Laboratory Improvements Amendments or CLIA waivers to for commercial tests. A CLIA waiver grants a recipient test with the privileged to be used without regulatory oversight. These waivers are usually awarded to test found by the FDA to be simple enough to be used by the public and those accurate enough that there is only little room for errors. Most waived tests are used widely used in hospitals, doctor’s clinics as well as in the occupational health field and in criminal justice applications.
The chief executive officer of ABMC, Stan Cipkowski , expresses his delight for receiving the CLIA waivers from the FDA, which according to him they have already been waiting for some time. He further notes that they expect this recent granting of CLIA waivers to have a positive impact on their relationship with their laboratory alliance. “Up until now, 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 explains.
Furthermore, the CEO reveals that the CLIA waiver have allowed his company to complete negotiations with a number of distributors supplying physicians and hospitals. The waivers are also set to to help the company penetrate new markets and open more doors for their products. “I expect to see an immediate impact on sales beginning in the fourth quarter of this year and ramping up throughout 2009,” Cipkowski divulged.
The ABMC is a biotechnology company involved in developing, manufacturing, and marketing immunoassay diagnostic kits such as the point of collection tests for drug abuse given the CLIA waiver. ABMC drug tests ranges from urine tests, oral fluids tests, and portable test devices.
The FDA , on the other hand, is a branch of the federal government with mandate to enforce laws on the manufacture, testing, and the use of drugs, food, and medical devices. Aside from, drug tests, the agency also grants CLIA waivers to non-automated urinalysis, fecal occult blood, urine pregnancy test, and ovulation tests among others.
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