Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the VENTANAⓇ CLDN18 (43-14A) RxDx Assay is the first U.S. Food and Drug Administration (FDA) approved immunohistochemistry (IHC) companion diagnostic for determining CLDN18 protein expression in tumours of patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma. These patients now may be eligible for treatment with Astellas' targeted therapy VYLOYTM (zolbetuximab).

Massachusetts and Singapore-based biotechnology company Sunbird Bio has raised $14m to advance the clinical development of its blood-based diagnostic platform for neurological disorders and early-stage cancer.

Yourgene Health (part of the Novacyt group of companies), a leading international molecular diagnostics group, announces that it has received accreditation under the new EU requirements of the in vitro diagnostic regulation (IVDR) for the Yourgene® Cystic Fibrosis Base assay. The Yourgene Cystic Fibrosis Base assay is a Class C in vitro medical device under IVDR and is intended for use by healthcare professionals within a molecular laboratory environment.

CareDx, Inc. (Nasdaq: CDNA) — The Transplant Company™ — a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers —today reported preliminary financial results for the third quarter ended September 30, 2024.

Abbott (NYSE: ABT) today announced financial results for the third quarter ended Sept. 30, 2024.

Original from: bioMérieux bioMérieux, a world leader in the field of in vitro diagnostics, announces the CE-marking of VIDAS® VITAMIN B12 TOTAL, an automated quantitative test for use on the VIDAS&..

Prenetics Global Limited (NASDAQ: PRE), a leading health sciences company, today announced that Tencent has made a strategic US$30 million investment in Insighta, a Hong Kong-based early cancer detection company. This investment values Insighta at US$200 million and underscores Tencent’s endeavor to advancing AI-powered innovations in healthcare.

Illumina has launched a new benchtop next-generation sequencing (NGS) system designed to be more accessible for use in smaller labs.

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the commercial launch of the first in a family of high-throughput, robotics-compatible reagent kits that will enable automation to ensure greater consistency and increased efficiency of large-scale, single-cell discovery studies.

The clinical application of molecular diagnostic technology is mainly in the form of detecting nucleic acid markers, including reagents and instruments, which are regulated by the National Medical Product Administrati..

China plans to allow the establishment of wholly foreign-owned hospitals in certain cities and regions across the country, according to an official document unveiled on Sunday.

Burning Rock Biotech and drugmaker Dizal said Thursday that they have received approval from China's National Medical Products Administration (NMPA) for a next-generation sequencing-based companion diagnostic for the lung cancer drug sunvozertinib.

Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®Liquid CDx to be used as a companion diagnostic for Itovebi™ (inavolisib) in combination with palbociclib (Ibrance®) and fulvestrant, a therapy developed by Genentech, a member of the Roche group, which has been contemporaneously approved for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.

Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today it has expanded its portfolio of sexually transmitted infection (STI) testing options to include the First to Know® Syphilis Test, the first over-the-counter blood test granted market authorization by the U.S. Food & Drug Administration (FDA) that can be performed by both physicians and patients.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the VENTANAⓇ CLDN18 (43-14A) RxDx Assay is the first immunohistochemistry (IHC) companion diagnostic test to receive CE Mark approval for determining CLDN18 protein expression in tumours of patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma. These patients now may be eligible for treatment with Astellas’ targeted therapy VYLOYTM (zolbetuximab).