PRESS RELEASE: TECHLAB® Receives FDA 510(k) Clearance to Market CAMPYLOBACTER QUIK CHEK™ and CAMPYLOBACTER CHEK™ Tests
BLACKSBURG, Va. – January 23, 2018 – TECHLAB®, Inc., a leading developer and manufacturer of rapid non-invasive diagnostic tests for gastrointestinal diseases, today announced that it received U.S. Food and Drug Administration (FDA) clearance for the CAMPYLOBACTER QUIK CHEK™ and the CAMPYLOBACTER CHEK™ tests. Both are intended to aid diagnosis 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. The CAMPYLOBACTER CHEK™ and CAMPYLOBACTER QUIK CHEK™ tests have accuracies that surpass culture and have the highest positive predictive values (PPV) among currently available Campylobacter immunoassays.
“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,” said Dr. Joel Herbein, VP of Scientific Affairs at TECHLAB. “The Campylobacter products we have developed have a high PPV, can be performed on the benchtop in 30 minutes for the rapid to about an hour for the 96-well plate format, and offer clinicians more confidence in their testing results.”
Campylobacter is a foodborne pathogen and is estimated to affect more than 1.3 million people annually in the United States.1 The CAMPYLOBACTER QUIK CHEK™ and CAMPYLOBACTER CHEK™ tests offer quick and reliable detection of Campylobacter-specific antigen in human fecal specimens.2
TECHLAB, Inc. (www.techlab.com) has been a leading developer and manufacturer of intestinal diagnostics products in the United States for 27 years. The Company has a market leading portfolio of diagnostic tests for enteric diseases caused by C. difficile, Shiga toxin producing E. coli, and protozoan parasites. TECHLAB also manufactures diagnostic tests for intestinal inflammation and performs diagnostics and life science contract manufacturing and services. TECHLAB is headquartered in Blacksburg, Va. and manufactures its diagnostic tests in the United States at its state-of-the-art manufacturing facility in Radford, Va.
1. Centers for Disease Control (2017, Oct. 2). Campylobacter (Campylobacteriosis). https://www.cdc.gov/campylobacter/faq.html.
2. CAMPYLOBACTER QUIK CHEK and CAMPYLOBACTER CHEK Package Inserts.