Through MDUFA V, the FDA committed to several international harmonization initiatives and secured additional resources to support the work. The publication of a draft strategic plan was the first item on the MDUFA V convergence and reliance agenda.

Streck announced on Monday that its MDx-Chex quality controls have received clearance from the US Food and Drug Administration.

QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, announced today that it has been granted CLIA Waiver from the U.S. Food and Drug Administration (FDA), applying to its new Sofia® 2 SARS Antigen+ FIA.

T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the T2Biothreat™ Panel. The FDA 510(k) clearance allows the company to immediately begin marketing and selling the T2Biothreat Panel in the U.S. market.

US Food and Drug Administration officials on Wednesday released draft guidance outlining the types of predicate device analysis and evidence they will expect in 510(k) clearance applications as they work to modernize the clearance process for medical devices, including in vitro diagnostics.

Quest Diagnostics (NYSE: DGX), the nation's leading provider of diagnostic information services, today announced that its AAVrh74 ELISA assay (CDx) has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).

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.