STDs

Hologic received clearance for a change to a probe reagent in the Aptima Combo 2 assay to detect variants of Chlamydia trachomatis that have emerged recently.

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

The company said clinical services revenues and diagnostic testing volumes rose during the quarter, but that PAMA continued to negatively affect reimbursements.

The assay detects 10 STIs and is performed on the molecular point-of-care Vivalytic platform, which was codeveloped by German company Bosch.

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

The new Series B investment was made by Northpond Ventures, with previously invested $20 million in the Australian diagnostics company.

Within diagnostics, the firm posted molecular diagnostics revenues of $178.5 million, up 9 percent from $164.3 million in fiscal Q1 2019.

The firms have agreed to develop infectious disease and women's heath testing assays using SpeeDx's proprietary technology.

The firm will use funds from the round, led by the Midlands Engine Investment Fund, to develop its optical point-of-care diagnostic testing platform.