Randox Laboratories announced that the U.S. Food and Drug Administration (FDA) has approved the De Novo application for the company’s first Companion Diagnostic (CDx). This is a major achievement for Randox following over 3 years of innovative development and collaboration with Novo Nordisk. The Companion Diagnostic was developed as a new option for determining the amount of medication a patient with hemophilia has received.

Cepheid today announced that Health Canada has issued Cepheid a medical device licence for Xpert® HIV-1 Viral Load XC, a next-generation extended-coverage (XC) test intended to aid in assessing HIV viral load levels, which are used to monitor effectiveness of antiretroviral treatment.

China's drug regulator has approved the country's first domestically developed 9-valent human papillomavirus (HPV) vaccine, ending over a decade of foreign dominance in the market.

Technical Platform POCT technology has gradually evolved from classical immunochromatography to more sensitive platforms hosting multiple detection technologies, such as luminescence and molecular detection. ..

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that its Shield multi-cancer detection (MCD) test has been granted Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). The Shield MCD test is a methylation-based blood test for the multi-cancer screening of multiple cancer types including bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreas cancer in individuals aged 45 or older who are at typical average risk for cancer.

QuidelOrtho Corporation (Nasdaq: QDEL) (the "Company" or “QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, today announced a refocusing of its molecular diagnostics strategy. This strategy includes the intent to acquire full ownership of LEX Diagnostics after 510(k) clearance by the U.S. Food and Drug Administration ("FDA") for consideration at closing of approximately $100 million and plans to discontinue the Company's Savanna platform development.

PathAI, a leading provider of AI-powered pathology solutions, and Northwestern Medicine, Chicago’s premier integrated academic health system, today announced a strategic collaboration to transform pathology diagnostics through artificial intelligence. This multi-year collaboration will see Northwestern Medicine implement PathAI’s AISight digital pathology image management system with the goal of driving efficiency and quality in pathology operations. In addition to the digital innovation efforts, this joint effort establishes a broad framework for joint research initiatives, clinical innovation programs, and co-development of new AI-powered diagnostic tools aimed at improving patient outcomes.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the expansion of its oncology diagnostics portfolio with two strategic partnerships to advance the use of minimal residual disease (MRD) testing in clinical trials to support pharma co-development projects for companion diagnostics. The new collaborations with Tracer Biotechnologies and Foresight Diagnostics expand QIAGEN’s reach in MRD testing and cover solid tumors and hematological cancers.

From May 21-23, 2025, Lei Haichao, Director of the National Health Commission of the P.R.C, led a delegation on an official visit to France.

Introduction Point-of-care testing (POCT) is a subfield of in vitro diagnostics (IVD), where portable analytical instruments and supporting reagents are used to obtain test results quickly at the sampling site. P..

Illumina Inc. (NASDAQ: ILMN) today announced an expanded clinical oncology portfolio, unlocking the next new solutions to advance precision oncology and improve the standard of care. The company's broad range of clinical offerings will accelerate access to precision oncology for more patients with cancer. Illumina tumor profiling and in vitro diagnostic (IVD) solutions will be on display at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

Agilent Technologies Inc. (NYSE: A) today reported revenue of $1.67 billion for the second quarter ended April 30, 2025, representing growth of 6.0% reported and up 5.3% core(1) compared with the second quarter of 2024.

Introduction Point-of-care testing (POCT) is a subfield of in vitro diagnostics (IVD), where portable analytical instruments and supporting reagents are used to obtain test results quickly at the sampling site. ..

Caris Life Sciences ® (“Caris”), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, today announced that it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (“SEC”) relating to a proposed initial public offering of its Class A common stock. The number of shares to be offered and the price range for the proposed offering have not yet been determined. Caris has applied to list its Class A common stock on the Nasdaq Global Select Market under the ticker symbol “CAI.”

Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, announced today that it has received approval from the Ministry of Health, Labour and Welfare (MHLW) for TruSightTM Oncology (TSO) Comprehensive for Class III/IV Medical Device (Specially Controlled Medical Device) in Japan. As genomic insights continue to drive breakthroughs in cancer treatment, the test is designed to make precision oncology more accessible to oncologists and patients.