Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received FDA approval for expanded use of its PATHWAY® HER2 (4B5) and VENTANA® HER2 Dual ISH DNA Probe Cocktail tests. These companion diagnostics are now approved to assess HER2-positive status in metastatic gastroesophageal adenocarcinoma (GEA) patients, including those with gastric, gastroesophageal junction, and esophageal adenocarcinoma. The approval enables clinicians to identify HER2-positive GEA patients who may be eligible for HER2-targeted treatment with Jazz Pharmaceuticals' ZIIHERA® (zanidatamab-hrii). Two ZIIHERA-containing regimens are now FDA approved for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive GEA.

Abbott (NYSE: ABT), the global healthcare leader, today announced U.S. Food and Drug Administration (FDA) authorization of its Libre Duo 10 Day system, the world's first dual glucose‑ketone sensing technology. The new biowearable is designed to alert people living with diabetes of rising ketones that can lead to a diabetic ketoacidosis (DKA) emergency, a serious health complication for people with diabetes. Libre Duo 10 Day delivers real-time visibility into glucose levels needed for daily diabetes management while also monitoring rising ketones in the background, avoiding additional mental or physical burden for people with diabetes. Abbott plans to launch Libre Duo 10 Day in the United States later this year.

The U.S. Food and Drug Administration has cleared Roche (ROPC.S), opens new tab and partner Eli Lilly's (LLY.N), opens new tab blood test to help ​identify signs of Alzheimer's disease in people aged ‌55 and older with cognitive decline.

The U.S. Food and Drug Administration announced today that it has cleared C2N Diagnostics' PrecivityAD2 blood test for use in adults as young as 40 who are experiencing signs of cognitive impairment, making it the first FDA-cleared Alzheimer's blood test available to patients this young. The clearance builds on nearly 20 years of ADDF investment in C2N's science and reflects the growing momentum of blood-based diagnostics in bringing earlier, more accurate detection into mainstream care and moving the field toward a new era of precision medicine.

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.