Biochips enable the accurate, rapid, and high-throughput detection of DNA, RNA, polypeptides, proteins, cells, tissues, and other biological components, with great advantages in disease screening and early diagnosis.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

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.

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.

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

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.

Illumina Inc. (NASDAQ: ILMN) today unveiled PromoterAI, a new AI algorithm that accurately deciphers pathogenic regulatory genetic variants in the noncoding regions of the human genome. A study published today in Science illustrates how this deep learning technology discovered regulatory variants in noncoding "promoter" segments that contribute up to 6% of the genetic causes of rare diseases. By turning data into insights, this technology is expected to help researchers accelerate new breakthroughs in diagnosis for rare diseases.

Danaher Corporation (NYSE: DHR) ("Danaher"), a global science and technology innovator, announced today the launch of a partnership with AstraZeneca (LSE/STO/Nasdaq: AZN) to develop and commercialize novel diagnostic tools and tests intended to help clinicians better determine which patients would most benefit from precision medicine treatments.