FDA clearance

Applied BioCode said that it now has access to higher volume laboratories that use the Roche MagNa Pure 96 System for sample extraction.

The assay is for detecting varicella-zoster virus in cerebrospinal fluid and can be used with the firm's Liaison MDx instrument.

The Aptima BV test detects bacterial vaginosis and the Aptima CV/TV detects and differentiates candida infections from trichomonas.

The Hologic Aptima Combo 2 and the Cepheid Xpert CT/NG assays have now been cleared for use in throat and rectum samples.

The QiaStat-Dx system will now be commercially available in the US along with a panel that detects more than 20 respiratory viral and bacterial pathogens.

The test detects Group A Strep in throat swab samples using the firm's rapid molecular diagnostics instrument called Revogene.

The FDA said it is the first test  authorized to test for M. genitalium, a slow-growing bacteria that is difficult to detect with traditional laboratory methods.

The clearance enables 23andMe to report on the two most common variations in the MUTYH gene influencing MAP, which increases risk of CRC development.

The molecular test detects and differentiates Bordetella pertussis and Bordetella parapertussis from fresh and frozen nasopharyngeal swab samples.