The biggest losers following the release of the preliminary PAMA rates may be Quest and LabCorp, analysts said today.
Luminex alleges that Curiox's objective has been to cobble together an unvalidated "Frankenstein-ish" system that fails at producing accurate test results.
The firm said that prior to entering clinical trials, it also needs to reduce failure rates of a cassette that is part of the Verigene 2 test.
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's real-time PCR assay for rapid detection and differentiation of novovirus genogroup I and II runs on the Aries sample-to-answer system.
The firm will encounter stiff competition, particularly from BioMérieux and Luminex, but there are untapped opportunities for adoption, according to industry analysts.