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.

Invitae (NYSE: NVTA), a leading medical genetics company, today announced it gained FDA market authorization for its Common Hereditary Cancers Panel.

Foundation Medicine Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for Eli Lilly and Company’s Retevmo (selpercatinib), which was approved by the FDA for the treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

Today, Sanguina, Inc. (Sanguina), a leading biotech company, is pleased to announce the FDA clearance of AnemoCheck Home, the only FDA-cleared home hemoglobin test kit available in the United States.

Thermo Fisher Scientific said on Wednesday that it has obtained US Food and Drug Administration clearance for its BRAHMS CgA II KRYPTOR test, a chromogranin A (CgA) immunoassay for assessing tumor progression in gastroenteropancreatic neuroendocrine tumor (GEP-NET) patients.