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.

Roche announced today the U.S. Food and Drug Administration (FDA) 510(k) clearance of its newest analytical units – the cobas® c 703 and cobas® ISE neo. As part of the scalable and modular cobas® pro integrated solutions, these additions deliver advanced lab-automation capabilities designed to help address some of today's most pressing laboratory challenges, including staff shortages, limited space and growing test volumes.

Hologic, Inc. (Nasdaq: HOLX) announced today that its Aptima® HPV Assay received FDA approval for clinician-collected HPV primary screening. Hologic’s human papillomavirus (HPV) test is the only FDA-approved mRNA-based assay, designed specifically to detect infections most likely to lead to cervical cancer.

Diasorin (FTSE MIB: DIA) announced today it has secured U.S. Food and Drug Administration (FDA) De Novo authorization for the first fully automated diagnostic test for hepatitis delta virus (HDV) on the Diasorin LIAISON XL immunoassay system. Designated as a Breakthrough Device by the FDA, the test aids in the diagnosis of HDV in individuals living with acute and chronic hepatitis B virus (HBV). The development of the automated diagnostic assay has been supported by Gilead Sciences.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved Guardant360® CDx as a companion diagnostic to identify patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC) who may benefit from treatment with BRAFTOVI® (encorafenib) in combination with cetuximab and chemotherapy in accordance with the approved product labeling.

Truvian Health (“Truvian”), a diagnostics company redefining routine blood testing, today announced U.S. Food and Drug Administration (FDA) clearance for the Complete Blood Count (CBC) on its TruVerus™ multi‑modal blood testing system (K251249).