chlamydia

Novel Microdevices is developing a portable, sample-to-answer instrument that is designed to perform molecular testing on untreated patient samples.

The 30-minute test can be used on samples from males and females in settings operating under a CLIA certificate of waiver.

The FDA cleared the point-of-care Binx io platform for the detection of chlamydia and gonorrhea in male urine specimens.

The GenFlex is a sample-to-result molecular diagnostic platform that includes sample collection, processing, amplification, and detection, the company said.

The Ithaca, New York-based firm has submitted its molecular diagnostic instrument along with a test to detect chlamydia, gonorrhea, and trichomonas.

The company said that the decline in revenues reflected lower industry-wide reimbursement rates under PAMA.