Thermo Fisher Scientific's new opioid treatment gains 501(k) clearance

Friday, August 11, 2017

Source: American Pharmacy News

Thermo Fisher Scientific recently received U.S. Food and Drug Administation 510(k) clearance for the company’s new immunoassay for the specific detection of buprenorphine and its three major metabolites. 

The immunoassay also received registration in Canada, Australia and New Zealand, as well as CE Mark and registration in various countries in the European Union.

The company delivered information about the product at the 2017 American Association of Clinical Chemistry (AACC) Annual Scientific Meeting & Clinical Lab Expo in San Diego, California. Thermo Fisher noted that Buprenorphine can be a more practical and often more effective alternative to methadone in treating opioid addiction.

"The CEDIA Buprenorphine II Assay is the only assay on the market that detects all three major metabolites," John Kody, vice president and general manager of clinical diagnostics at Thermo Fisher Scientific, said in a statement. "The ability to detect each of these metabolites is important because it minimizes the potential for false-negative results."

Thermo Fisher, a global leader in accelerating life sciences research with more than 55,000 employees around the globe and revenues of $18 billion, helps its customers solve complex analytical challenges and improve patient diagnostics.

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