TOBY, Inc., a biotechnology company developing non-invasive disease detection technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the TOBY Test for Alzheimer's Disease. The designation recognizes the test's potential to aid in the diagnosis of Alzheimer's disease through a simple, non-invasive urine sample and address a major unmet need in accessible cognitive evaluation and diagnostic care.

Foundation Medicine, Inc., a global, patient-focused precision medicine company, 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 (CDx) for TEPMETKO® (tepotinib) developed by EMD Serono, the healthcare business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada. TEPMETKO received accelerated approval from the FDA in February 2021 and traditional approval in February 2024 for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations (METex14).

Diasorin (FTSE MIB: DIA) announced today that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the LIAISON PLEX Gastrointestinal Flex Assay, a fully customizable syndromic testing panel capable of detecting a market-leading 24 gastrointestinal pathogen targets. The new panel expands Diasorin’s growing LIAISON PLEX assay portfolio, which also includes a customizable respiratory assay and three blood culture panels.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved Guardant360® Liquid CDx, advancing blood-based comprehensive genomic testing by integrating genomic and epigenomic insights and helping clinicians make better-informed treatment selection decisions for patients with advanced cancer. Guardant360 Liquid CDx is the largest FDA-approved liquid biopsy panel, assessing a 100X wider genomic footprint than the previously approved Guardant360 CDx to deliver comprehensive tumor profiling results. The seven previously U.S. FDA-approved companion diagnostic indications for Guardant360 CDx transfer to the new test with the FDA approval of Guardant360 Liquid CDx.

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that the U.S. Food and Drug Administration (FDA) has approved Signatera CDx as a companion diagnostic (CDx) for use with adjuvant atezolizumab (Tecentriq®) immunotherapy in MIBC.

Revvity, Inc., through its subsidiary, Immunodiagnostic Systems (IDS), today announced that it received clearance from the U.S. Food and Drug Administration (FDA) for its Total Testosterone automated chemiluminescence immunoassay (ChLIA). This offering complements the Company’s FDA-cleared ChLIA tests for free testosterone and sex hormone-binding globulin (SHBG), delivering a first of its kind, complete solution for testosterone-related disorders on a single platform.

Laguna Diagnostics, LLC today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the company's mRNA Gene Biomarker Test, a novel blood-based test designed to aid in the differentiation of schizophrenia and bipolar I disorder in symptomatic patients.

QuidelOrtho Corporation (Nasdaq: QDEL) (the "Company" or "QuidelOrtho"), a global leader of innovative in vitro diagnostics, announced today it has completed the acquisition of LEX Diagnostics ("LEX") for cash consideration of approximately $100 million. The LEX VELO System received U.S. Food and Drug Administration ("FDA") 510(k) clearance and CLIA waiver in February 2026.

Waters Corporation (NYSE: WAT) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Onclarity HPV Self-Collection Kit and approved the BD Onclarity HPV Assay with extended genotyping for at-home use, marking a significant milestone in expanding access to cervical cancer screening, and removing barriers that currently prevent many individuals from receiving routine screening.

Lumos Diagnostics has today announced that U.S. FDA has granted 510(k) clearance with CLIA waiver for FebriDx®, enabling broader use across frontline healthcare settings and significantly expanding its commercial opportunity.