News in Brief
Techlab receives clearance for campylobacteriosis diagnosis tests
Campylobacter Quik Chek is a rapid diagnostic test that detects C. jejuni and C. coli in less than 30 minutes.
Campylobacter Chek test is a 96-well plate format for labs testing large numbers of specimens and can be used with or without automation.
The tests offer detection of Campylobacter-specific antigen in human fecal specimens.
Campylobacter causes an estimated 1.3 million illnesses each year in the US, according to the Centers for Disease Control and Prevention (CDC).
The developer of rapid non-invasive diagnostic tests said they are more accurate than culture and have the highest positive predictive values (PPV) among 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%. 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.
Techlab is headquartered in Blacksburg, Virginia and manufactures its diagnostic tests at a facility in Radford, Virginia.
Pharos Capital Group acquired a controlling position in TechLab in late 2016.
Pharos bought the stake from Alere Inc. and TechLab’s founders Dr Tracy Wilkins and Dr David Lyerly who remained with the company and maintained a minority investment.
