The US Food and Drug Administration on Tuesday released a proposal to reclassify companion diagnostic assays from Class III medical devices to Class II devices.

Thermo Fisher Scientific, the world leader in serving science, has received approval from the U.S. Food and Drug Administration (FDA) for its Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients who may be candidates for HERNEXEOS® (zongertinib tablets), a tyrosine kinase inhibitor (TKI), developed by Boehringer Ingelheim. The test allows clinicians and pathologists to assess if non-small cell lung cancer (NSCLC) tumors harbor human epidermal growth factor receptor 2 (HER2/ERBB2) tyrosine kinase domain (TKD) activating mutations.

Abbott Laboratories is nearing a potential acquisition of cancer screening company Exact Sciences Corp., people familiar with the matter said, in what could be the biggest deal of the year in the global health-care sector.

The U.S. Food and Drug Administration (FDA) has approved the Promega OncoMate® MSI Dx Analysis System as a companion diagnostic designed to identify patients with microsatellite stable (MSS; defined as not MSI-high [not MSI-H]) endometrial carcinoma who may benefit from treatment with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, plus LENVIMA® (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. This is the first Promega companion diagnostic to receive FDA approval.

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced 510(k) clearance of the EXENT® Analyser and Immunoglobulin Isotypes (GAM) Assay**, a first-of-its-kind automated platform for clinical laboratories. The EXENT System combines enhanced sensitivity and automation to provide accurate results, helping clinicians make a fast diagnosis for patients with multiple myeloma and related disorders.

BD (Becton, Dickinson and Company) (NYSE: BDX) a leading global medical technology company, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Conformité Européenne (CE) marking in the European Union for its Enteric Bacterial Panel* (EBP) and Enteric Bacterial Panel plus* (EBP plus) for the BD COR™ System.

The U.S. Food and Drug Administration ("FDA") has granted QuidelOrtho Corporation (Nasdaq: QDEL) ("QuidelOrtho"), a global leader of in vitro diagnostics, 510(k) clearance for the VITROS hs Troponin I Reagent Pack (the "VITROS hs Troponin I Assay"). The assay is intended for the quantitative measurement of cardiac troponin I (cTnI) in human plasma (heparin) to aid in the diagnosis of myocardial infarction (MI).

Diasorin said Friday that it has secured US Food and Drug Administration 510(k) marketing clearance for a syndromic respiratory disease test.

Tosoh Bioscience, Inc., a market leader in clinical diagnostics has received U.S. FDA 510(k) clearance for its next-generation Tosoh Automated Glycohemoglobin Analyzer HLC®-723 GR01 (GR01) for HbA1c testing.

At the annual IDWeek meeting (https://idweek.org/), Bruker announced the U.S. Food and Drug Administration (FDA) clearance of Claim 7 and Claim 8 for its MALDI Biotyper® CA System, marking a significant advancement in clinical microbial identification capabilities. The clearance includes the MBT Compass HT CA software and MBT FAST™ Shuttle US IVD (Claim 7), as well as a major expansion of the FDA-cleared reference library (Claim 8), now encompassing 549 clinically validated microbial species across gram-positive and gram-negative bacteria, anaerobes and yeasts.