Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today the global launch of the VENTANA® BAP1 (SP527)* test. This automated, ready-to-use immunohistochemistry (IHC) assay provides a reliable, highly specific diagnostic tool to help clinicians and pathologists accurately identify mesothelioma and distinguish it from other malignancies, including non-small cell lung cancer (NSCLC). The BAP1 assay is registered as a Class I IVD with the U.S. Food and Drug Administration, has received IVDR approval as a Class C device, and is available globally.

SEKISUI Diagnostics, a global medical diagnostics manufacturer, has announced the launch of a 510(k) cleared rapid test to detect COVID-19 and Flu A&B in professional healthcare settings.

Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that it has received the CE Mark for its cobas smart e immunoanalyser, a compact, standalone platform engineered to deliver reliable testing with a planned menu of over 100 high-medical-value assays. As the latest offering in Roche¡¯s industry-leading cobas immunoassay systems portfolio, the platform bridges critical operational gaps across health systems by fitting central-laboratory precision into a footprint under one square meter. This enables decentralised sites to manage diverse testing demands directly in-house. With reaction times of 18 minutes or less across more than 90% of Roche immunoassays, local facilities can help reduce diagnostic turnaround times.

Labcorp (NYSE: LH), a global leader in innovative and comprehensive laboratory services, and Millennium Health, an accredited specialty laboratory with more than 15 years of experience in drug testing and surveillance, today announced that they have entered into a definitive agreement for Labcorp to acquire Millennium Health.

Original from: bioM¨¦rieux bioM¨¦rieux, a world leader in the field of in vitro diagnostics, today announced that its BIOFIRE® SPOTFIRE® Vaginitis (VG) Panel has received Dual 510(k) Clearance a..

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) (¡°QIAGEN¡± or the ¡°Company¡±) and the EQT XI fund (¡°EQT Private Equity¡±) today announced an agreement under which Crown NL Bidco B.V. (the ¡°Bidder¡±) announced its decision to make an all-cash voluntary public takeover offer for the acquisition of all outstanding QIAGEN shares at €46.50 per share (the ¡°Takeover Offer¡±).

Agilent Technologies Inc. (NYSE: A) today announced it has entered into a definitive agreement to acquire Proscia®, a provider of digital pathology software for clinical and life-sciences customers, in an all-cash transaction valued at $240 million in cash at closing and up to an additional $30 million based on achieving future performance milestones.

Roche Diagnostics LightCycler® PRO System Receives NMPA Approval Roche Diagnostics¡¯ LightCycler® PRO System, a real-time quantitative PCR (qPCR) analyzer, has received approval from China¡¯s Nati..

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that its multi-cancer early detection (MCED) assay has been granted Breakthrough Device designation (BDD) by the U.S. Food and Drug Administration (FDA). The BDD is designed for novel technologies that enable more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases or conditions.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that Guardant360® CDx has received CE-marking under Europe¡¯s in Vitro Diagnostic Medical Devices Regulation as a companion diagnostic (CDx) to identify patients with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer who may benefit from treatment with ETCAMAH™ (camizestrant), AstraZeneca¡¯s next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist. Approval in Europe reinforces Guardant Health's commitment to enabling practice-changing ongoing monitoring across the world's largest healthcare markets.

Tempus (NASDAQ: TEM) today announced an expanded, multi-year collaboration to support the potential commercialization of intismeran autogene (V940/mRNA-4157), a novel, potential first-in-class individualized neoantigen therapy (INT) being evaluated in combination with KEYTRUDA® (pembrolizumab), Merck¡¯s anti-PD-1 therapy, in patients with completely resected stage IIB-IV melanoma and other cancer types. Intismeran autogene is jointly developed by Moderna and Merck, known as MSD outside of the United States and Canada. The collaboration builds on joint efforts initiated last year and will support preparations for the potential commercialization of intismeran autogene.

CellCarta, a leading global CRO laboratory to the biopharmaceutical industry, today announced a strategic partnership with Waters Corporation, a global leader in life sciences and diagnostics, creating a framework to jointly pursue companion diagnostic (CDx) and next-generation flow cytometry opportunities with pharmaceutical and biotechnology companies.

Original from: PR Newswire SOPHiA GENETICS (NASDAQ: SOPH) and Myriad Genetics, Inc., (NASDAQ: MYGN) today announce a collaboration to advance new prostate cancer-specific genomic instability score (PrGIS..

Original from: Truvian Health Truvian Health (¡°Truvian¡±), a diagnostics company transforming routine blood testing through its automated benchtop platform, today announced a strategic alliance withSiem..

Revvity, Inc. (NYSE: RVTY) today announced the launch of the GSP® T1D 3plex kit, a fully automated, CE-IVDR-certified, multiplex autoantibody (AAb) detection solution to enable population-wide screening programs that identify children at risk of developing type 1 diabetes (T1D) before symptoms appear.

Werfen today announced that its Aptiva Antiphospholipid Syndrome (APS) Immunoglobulin A (IgA) Reagent has received both U.S. Food and Drug Administration (FDA) 510(k) clearance and CE Mark under the European Union¡¯s In Vitro Diagnostic Medical Devices Regulation (IVDR). Together, these milestones complete the Aptiva APS testing portfolio, which now offers all three APS isotypes, IgA, IgG, and IgM, for both anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (a¦Â₂GP1) antibodies.

2.4 Product and Technology Innovation of Urinalysis System (Workflow) 2.4.1 US-3000/US-1680 Urinalysis Workflow It is a product of URIT. On the basis of the original urine routine analysis workflow..

Teal Health, creators of the Teal WandTM, the first and most accurate FDA-authorized self-collection device for at-home HPV cervical cancer screening, today announced $22 million in Series A funding to meet accelerating consumer demand and expand access ahead of broad insurance coverage beginning in January 2027.

Original from: Natera Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that its Signatera test has received regulatory approval from Japan¡¯s Pharmace..

Abbott and Bioscience Launch Strategic Partnership for Rapid Respiratory Infection Testing On September 18, Bioscience announced the signing of a strategic cooperation agreement with Abbot..