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Basel, 22 January 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for its cobas® liat sexually transmitted infection (STI) multiplex assay panels. These panels, including tests for chlamydia and gonorrhea (CT/NG) and chlamydia, gonorrhea and Mycoplasma genitalium (CT/NG/MG), enable clinicians to diagnose and differentiate between multiple STIs with a single sample. These tests will be exclusively available in the U.S. market in the coming months, with commercialisation under CE mark expected to follow shortly.
Dublin, Jan. 17, 2025 (GLOBE NEWSWIRE) -- The "Innovation Insights: B-cell Depletion" report has been added to ResearchAndMarkets.com's offering.
The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay is the first clinically approved in-situ hybridisation (ISH) test with the sensitivity to assess the full spectrum of B-cell lymphoma subtypes.1,2 The test helps differentiate a B-cell cancer from a normal, reactive immune response, offering diagnostic certainty for healthcare providers and their patients. B-cell lymphoma accounts for approximately 85 percent of non-Hodgkin lymphoma (NHL) cases, which is one of the most common cancers in the US.3 TUCSON, Ariz.
The VENTANA DP 600 slide scanner, part of Roche's Digital Pathology Dx system, is now cleared by the FDA to aid in clinical diagnosis, enabling pathologists to diagnose patients using digital images. This 240-slide scanner produces excellent image quality of stained histology slides from patient tissue samples, while providing ease-of-use and workflow flexibility for the pathology lab.
Swiss healthcare firm Roche has said its US$1.5 billion takeover of US biopharmaceutical company Poseida Therapeutics will be completed on Wednesday. Roche on Wednesday said it had been accepted for payment on 65 million shares in Poseida, which specialises in complex immune cell therapies for types of blood cancer.
Roche on Wednesday said it planned to complete its purchase of U.S. biopharmaceutical company Poseida Therapeutics via its subsidiary Blue Giant Acquisition Corp.
Basel, 8 January 2025 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Roche's wholly owned subsidiary Blue Giant Acquisition Corp. has accepted for payment all shares validly tendered and not validly withdrawn pursuant to its tender offer for all outstanding shares of common stock of Poseida Therapeutics, Inc. (“Poseida”, NASDAQ: PSTX) at a price of $9.00 per share in cash, plus a non-tradeable contingent value right (CVR) to receive certain contingent payments of up to an aggregate of $4.00 per share in cash. The tender offer expired at one minute following 11:59 p.m., New York City time on 7 January, 2025, and was not extended.
Vabysmo Sales Accounts For More Than 35% Of Global Bispecific Antibodies Market Says Kuick Research Vabysmo Sales Accounts For More Than 35% Of Global Bispecific Antibodies Market Says Kuick Research
Roche Executing Commercially, But R&D Productivity Remains A Work In Progress
RHHBY obtains FDA approval for Itovebi, a targeted treatment for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation.