The US Food and Drug Administration said Thursday that it has granted Roche Emergency Use Authorization for a new version of its multiplex molecular assay for detecting SARS-CoV-2 and influenza A/B.

The US Food and Drug Administration (FDA) has approved LetsGetChecked’s at-home testing system for chlamydia and gonorrhoea.

Agilent Technologies on Tuesday said it gained US Food and Drug Administration approval of the firm's PD-L1 companion diagnostic assay for use in identifying gastric or gastroesophageal junction adenocarcinoma patients for a combination treatment with Merck's Keytruda (pembrolizumab) checkpoint inhibitor.

Roche announced on Tuesday that its Cobas HPV test has received approval from the US Food and Drug Administration for use on the Cobas 5800 instrument.

Abbott announced on Thursday that its molecular test for human papillomavirus has received regulatory approval from the US Food and Drug Administration.

Werfen announced recently that its subsidiary Inova Diagnostics has secured US Food and Drug Administration 510(k) clearance for a blood-based immunoassay reagent used to aid the diagnosis of connective tissue diseases.

Abbott's RealTime IDH1 Assay has received approval from the US Food and Drug Administration as a companion diagnostic for Servier Pharmaceuticals' Tibsovo (ivosidenib) in patients with relapsed or refractory myelodysplastic syndrome, the FDA announced on Tuesday.

Werfen has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Aptiva Connective Tissue Disease (CTD) Essential reagent.

Roche subsidiary Foundation Medicine announced on Thursday that the US Food and Drug Administration has approved two of its companion diagnostic tests for use with Pfizer's Braftovi (encorafenib) in combination with Mektovi (binimetinib) for patients with metastatic non-small cell lung cancer with a BRAF V600E mutation.

As more and more medical technologies are being built on artificial intelligence and machine learning, the FDA is enlisting a new panel of outside experts to help it get deeper into the weeds.