GenInCode announced Wednesday that it filed a 510(k) submission for its CARDIO inCode-Score (CIC-Score) in vitro polygenic risk score (PRS) test for cardiovascular disease with the US Food and Drug Administration.

Roche subsidiary Foundation Medicine announced on Monday that its FoundationOne CDx test received approval from the US Food and Drug Administration for use as a companion diagnostic for Janssen Biotech's Akeega (niraparib and abiraterone acetate).

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. Food and Drug Administration (FDA) approval of its therascreen PDGFRA RGQ PCR kit (therascreen PDGFRA kit).

Abbott has received U.S. Food and Drug Administration clearance for its advanced Alinity® h-series hematology system, paving the way for laboratories throughout the country to run complete blood counts (CBC) as a part of Abbott’s Alinity family of diagnostic products.

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD Respiratory Viral Panel (RVP) for BD MAX™ System, a single molecular diagnostic combination test that identifies and distinguishes SARS-CoV-2, influenza A, influenza B, and Respiratory Syncytial Virus (RSV) in approximately two hours.

Meridian Bioscience said on Tuesday that it has received US Food and Drug Administration clearance for its Premier HpSA Flex assay for the diagnosis of Helicobacter pylori in both preserved and unpreserved stools.

Invivoscribe is excited to announce that the LeukoStrat CDx FLT3 Mutation Assay has been approved by the U.S. Food and Drug Administration (FDA) to aid in the selection of patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) who may be eligible to receive treatment with Daiichi Sankyo’s VANFLYTA® (quizartinib).

Siemens Healthineers said Thursday that it has received US Food and Drug Administration clearance for an analyzer designed for immunoassay and clinical chemistry testing in low- to medium-volume laboratories.

The US Food and Drug Administration (FDA) has granted approval for Lumos Diagnostics’ FebriDx rapid point-of-care (POC) test.

Renalytix has received De Novo marketing authorisation from the US Food and Drug Administration (FDA) for its KidneyIntelX.dkd prognostic test.