Fujirebio today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test for the assessment of amyloid pathology in patients being evaluated for Alzheimer’s disease and other causes of cognitive decline. The test, which was granted Breakthrough Device Designation by the FDA, is the first FDA cleared blood-based IVD test in the U.S. to aid to identify patients with amyloid pathology associated with Alzheimer’s Disease (AD).

Targeted Genomics on Wednesday announced a commercial collaboration with OraSure Technologies for direct-to-consumer celiac disease testing using the OraCollect-Dx saliva collection device and GlutenID test.

Singapore-based microRNA diagnostics firm MiRxes said Thursday that it has launched an initial public offering on the Hong Kong Stock Exchange, selling 46,620,000 Hong Kong offer shares and 41,958,000 international offer shares at HK$23.30 (US$2.98) per share for approximately HK$880.5 million (US$112.8 million) in net proceeds.

U.S. President Donald Trump's executive order on drug pricing threatens Roche's (ROG.S), opens new tab planned $50 billion investment in the United States, the company said on Wednesday.

Original from: Roche - The VENTANA MET (SP44) RxDx Assay detects the MET (also known as c-Met) protein, which is over-expressed in some patients with non-squamous non-small cell lung cancer (NSQ-NSCLC). ..

China will adjust tariffs on imported U.S. products from 12:01 p.m. Wednesday, the Customs Tariff Commission of the State Council announced on Tuesday.

Original from: GRAIL GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today reported business and financial results for the first quarter 202..

Teal Health®, a women’s health company on a mission to eliminate cervical cancer, today announced the Food and Drug Administration’s (FDA) approval of the Teal Wand™, the first and only at-home vaginal sample self-collection device for cervical cancer screening in the United States.

The immunoassay segment accounts about 35% of the market, with no growth compared to the previous year. Domestic brands account for over 35%.

Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery through ultra-sensitive biomarker detection, today announced financial results for the first quarter ended March 31, 2025.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced it has signed a definitive agreement to acquire Genoox, a provider of AI-powered software that enables clinical labs to scale and accelerate the processing of complex genetic tests.

Roche Invests Over 2 Billion CNY to Establish New Production Base in Pudong, Shanghai The groundbreaking ceremony for Roche China's new biopharmaceutical production base was held at the Zhangjiang Scienc..

OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-need and home diagnostic tests and sample management solutions, today announced its financial results for the three months ended March 31, 2025.

The US Food and Drug Administration (FDA) has set an “aggressive” timeline to implement generative artificial intelligence (genAI) across the agency by 30 June 2025.

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today reported its financial results for the first quarter ended March 31, 2025.