The US Food and Drug Administration (FDA) has decided to waive CLIA to American Bio Medica Corporation’s Rapid TOX product line. The waiver covers all fourteen drugs that the said company is testing for. It also encompassed two other cut-off levels that are intended for the company’s Opiate and Cocaine tests.
The FDA usually decides to grant CLIA waivers on certain tests that are easy to use and that which entails little risk for error due to their accuracy. These types of tests are in high demand these days among occupational health and criminal justice sectors.
ABMC Chief Executive Office Stan Cipkowski expressed his pleasure on this good news in an interview. ?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.
Rapid TOX is ABMC’s own line of urine based point of collection products. The waiver is a step for the company towards tapping into the hospital market with new products and more innovative testing devices. ?
American Bio Medica Corporation is popular for its line of cost-effective immunoassay diagnostic test kits and efficient point of collection tests for addictive and abused drugs. It has a worldwide distribution network composed of government institutions, clinics, schools and controlled facilities. Most of its drug screen products including the Rapid Drug Screen and Rapid TOX work by testing the presence and absence of drugs in urine samples. OralStat and Rapid STAT, on the other hand are designed to test the presence of these substances in oral fluids.
More cost-effective drug testing devices will help medical facilities, schools and government institutions in stopping drug abuse and providing ample help for those who are already found to be hooked on these substances. With more of ABMC’s cheaper products available in the market, hospitals and other facilities now have a wider array of options to choose from.
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