Leica Biosystems, a Danaher company and a global leader in end-to-end anatomic and digital pathology solutions, today announced multiple U.S. Food and Drug Administration (FDA) 510(k) clearances that strengthen its connected clinical digital pathology portfolio, including the industry's first standalone, AI-assisted quality control software. These advancements are designed to help pathology laboratories deliver high-quality digital images more consistently and efficiently to support timely, confident diagnoses for patients at a critical moment when case volumes, staffing pressures, and diagnostic complexity continue to increase.

Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced that the U.S. Food and Drug Administration (FDA) has approved Labcorp's PGDx elio® tissue complete CDx as a companion diagnostic to help identify patients with advanced melanoma with certain BRAF variants who may benefit from treatment with FDA-approved targeted therapies.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx BCID GPF Plus AMR Panel, the first QIAstat-Dx panel for bloodstream infections to receive FDA clearance.

Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx" or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that it has submitted a Dual 510(k) premarket notification, with a concurrent CLIA Waiver by Application, to the U.S. Food and Drug Administration ("FDA") for the Co-Dx™ PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro® instrument*. The submission follows the Company's previously announced completion of the clinical and analytical performance studies supporting the test.

Proscia® has received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Concentriq® AP-Dx. The clearance includes compatibility with the Leica Aperio® GT 450 DX slide scanner, cloud deployment, and a Predetermined Change Control Plan (PCCP). Concentriq AP-Dx is a digital pathology platform for primary diagnosis used by laboratories of all sizes.

bioMérieux, a world leader in the field of in vitro diagnostics, today announces the submission of the BIOFIRE® FILMARRAY® Gastrointestinal 1.1 (GI1.1) Panel and the BIOFIRE® FILMARRAY® Gastrointestinal 1.1 (GI1.1) Panel Mid to the U.S. Food and Drug Administration (FDA) for 510(k) review. These PCR* molecular panels test 22 and 11, respectively, of the most common bacteria, viruses, and parasites associated with gastroenteritis, all from one sample, with results available in approximately one hour.

The U.S. FDA has approved Freenome's (FRNM.O), opens new tab blood-based colorectal cancer ​screening test for older adults, paving the way for partner ‌Abbott (ABT.N), opens new tab to launch it in the U.S. this fall, the companies said on Monday.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its cobas® BV/CV (Bacterial vaginosis/Candida vaginitis) assay. This molecular diagnostic test provides results for both Bacterial vaginosis (BV) and Candida vaginitis (CV) from a single vaginal swab sample. It enables accurate and timely results that can lead to improved patient outcomes and enhanced healthcare efficiencies.

OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in point-of-care and home diagnostic testing and sample collection technologies, announced today that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its second generation OraQuick™ Ebola 2.0 Rapid Antigen Test for use with whole blood in live patients, as well as cadaveric oral fluid from individuals suspected to have had Ebola disease at the time of death. The test can detect all four Ebola viruses currently known to cause disease in humans: Bundibugyo, Zaire, Sudan, and Taï Forest.

Seegene, Inc. ("Seegene"), a global leader in molecular diagnostics, announced today that its U.S. subsidiary, Seegene USA, Inc. ("Seegene USA"), has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the Allplex™ HSV-1&2/VZV/MPXV Assay, a multiplex real-time PCR assay designed to simultaneously detect multiple viral pathogens associated with clinically overlapping lesion presentations.