The firm said that it is delaying clinical trials prior to its FDA submission of Verigene 2 for several reasons, including reducing cassette failure rates.
The fourth test for which the firm has received regulatory clearance this year takes aim at a common microbial cause of healthcare-associated infections.
The firm will encounter stiff competition, particularly from BioMérieux and Luminex, but there are untapped opportunities for adoption, according to industry analysts.
The real-time PCR, sample-to-answer assay provides surveillance of whooping cough, a contagious respiratory disease, in clinically symptomatic patients.
