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.

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States Food and Drug Administration (FDA) has cleared its Elecsys pTau181 test, the only blood-based biomarker (BBM) test indicated as an aid in the initial assessment for Alzheimer’s disease and other causes of cognitive decline in the primary-care setting. The Elecsys pTau181 test is intended for patients ages 55 and older presenting with signs, symptoms or complaints of cognitive decline. It measures phosphorylated Tau (pTau) 181 protein in human plasma, a key biomarker for Alzheimer’s pathology, including amyloid plaque and tau aggregate pathology.

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the completion of the Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”) acquisition. Verona Pharma is now a wholly-owned subsidiary of Merck and the American Depositary Shares (ADS) of Verona Pharma will no longer be listed or traded on the Nasdaq Global Market.

Hologic, Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays. The company also announced that the assays obtained CE marking in the European Union in accordance with In Vitro Diagnostic Regulation (IVDR). These highly sensitive molecular tests are designed to rapidly detect the most common bacterial pathogens responsible for infectious gastroenteritis.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved its Guardant360® CDx as a companion diagnostic to identify advanced breast cancer patients with ESR1 mutations who may benefit from Eli Lilly and Company’s Inluriyo (imlunestrant). Guardant360 CDx was approved in conjunction with Inluriyo for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy (ET).

Biolinq Incorporated, a pioneering developer of precision multi-analyte biosensors to improve metabolic health, today announced the U.S. Food and Drug Administration has granted De Novo Classification for its lead product, Biolinq Shine™. With this classification, Biolinq has a clear path forward to scale a new generation of wearable sensors designed for comfort, simplicity, and global reach.

Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its RNA-based Tempus xR IVD device. xR IVD will be offered as a life sciences tool to support drug development programs.

The US Food and Drug Administration (FDA) issued finalized guidance on Monday outlining the criteria for authorizing emergency use of unapproved in vitro diagnostic tests (IVDs) during future public health emergencies.