FDA grants 510 (k) Clearance to market TECHLAB’S CAMPYLOBACTER QUIK CHEK and CAMPYLOBACTER CHEK Tests

Developer and manufacturer of rapid non-invasive diagnostic tests for gastrointestinal diseases, TECHLAB sought U.S FDA’s clearance for the CAMPYLOBACTER QUIK CHEK and the CAMPYLOBACTER CHEK tests.  Both are implied to aid diagnosis and treatment of campylobacteriosis, one of the most common causes of diarrheal illness in the United States. The CAMPYLOBACTER QUIK CHEK test is a rapid diagnostic test that detects Campylobacter jejuni and Campylobacter coli in less than 30 minutes. The CAMPYLOBACTER CHEK™ test is a 96-well plate format for laboratories testing large numbers of specimens, and can be used with or without automation. Campylobacter is a foodborne pathogen and is estimated to affect more than 1.3 million people annually in the United States.

Dr. Joel Herbein, VP of Scientific Affairs at TECHLAB said “Most Campylobacter testing is still performed by culture because the diagnostic immunoassays on the market have a PPV value of less than 50 percent.  But culture requires up to 72 hours to give a result and is technically challenging due to the microaerophilic growth requirements of the bacteria.”