Close Menu

FDA clearance

The Frederick, Maryland-based firm has received regulatory clearance for a multiplexed array-based assay after more than 15 years in development.

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.

Direct-to-consumer genetic testing firm 23andMe has a newly cleared colorectal cancer risk test.

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.

Pages

The Wall Street Journal looks into FamilyTreeDNA's handling of genetic genealogy searches by law enforcement.

In a point-counterpoint in the Boston Globe, researchers discuss the potential of gene editing to prevent Lyme disease, but also the pitfalls of doing so.

MIT's Technology Review reports that researchers hope to develop a CRISPR-based pain therapy.

In Science this week: atlas of malaria parasites' gene expression across their life cycles, and more.