Diagnostics Regulatory News

The latest headlines on diagnostics regulation: FDA, CMS, and international regulatory agencies.

The firm said that the assay uses vaginal or rectal swabs to identify Group B Streptococcus DNA in about an hour. It has filed for 510(k) clearance with the US FDA.

The test is designed to detect the presence or absence of the Zika virus in serum or plasma collected alongside urine from patients with suspected infection.

The test is designed to detect cancer-driver gene variants associated with certain targeted solid tumor therapies, and is validated as a companion diagnostic.

The test is approved to gauge germline BRCA mutations in advanced breast cancer patients who may benefit from treatment with Pfizer's PARP inhibitor Talzenna.

The PCR assay is intended to help detect TB-causing bacteria and determine if it harbors mutations associated with isoniazid and rifampicin resistance.