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

According to the network statistics, market size of China’s blood group reagent was RMB 2.55 billion in 2024, which is expected to achieve RMB 2.86 billion in 2025 with growth rate of 12.3%.

French biopharma Sanofi has inked a partnership deal with Pangaea Data to use its AI platform that helps detect Alpha-1 Antitrypsin Deficiency (AATD), which will be distributed to select healthcare systems and low-income community care clinics.

Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx" or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that a delegation from CoMira Diagnostics ("CoMira"), the Company's joint venture with partners in the Kingdom of Saudi Arabia ("KSA"), visited Co-Diagnostics' Salt Lake City headquarters ahead of a planned technology transfer to CoMira. The visit included a tour of the Company's facilities and unveiling a future automated manufacturing line at a technology and innovation event also attended by state officials, trade representatives, and community leaders.

Diasorin (FTSE MIB: DIA) announced today that it has received 510(k) clearance and CLIA waiver from the U.S. Food and Drug Administration (FDA) for its Group A Streptococcus (GAS) assay, to be used on the LIAISON NES Point-of-Care (POC) molecular diagnostics platform. This milestone follows the FDA clearance of the LIAISON NES FLU A/B, RSV & COVID-19 assay in December 2025, further expanding the platform’s menu and clinical utility.

Nivi, Inc., a digital health innovator specializing in personalized healthcare guidance and consumer insights, and MSD (known as Merck Sharp & Dohme LLC in the United States and Canada, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA) today announced a global initiative to enhance consumer awareness of HPV diseases and HPV-related cervical cancer prevention across emerging markets, beginning with India, Indonesia, and Thailand.

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

Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the VENTANAⓇ PTEN (SP218) RxDx Assay is the first immunohistochemistry (IHC) companion diagnostic test to receive U.S. Food and Drug Administration (FDA) approval for determining PTEN protein loss, also known as PTEN deficiency, in tumours of patients with prostate adenocarcinoma. These patients may now be eligible for treatment with AstraZeneca’s targeted therapy TRUQAPⓇ (capivasertib).

Cepheid, a Danaher company, today announced it has donated an initial shipment of Xpert® Hemorrhagic Fever panel tests to support the diagnostic response to the Ebola Bundibugyo (BDBV) outbreak in the Democratic Republic of the Congo (DRC) and Uganda. The World Health Organization (WHO) declared the outbreak a Public Health Emergency of International Concern on May 17, 2026.

Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today the European Union In Vitro Diagnostic Regulation (IVDR) approval of several label expansions for the VENTANA® MMR RxDx Panel, an immunohistochemistry (IHC) companion diagnostic test that aids in identifying a cancer patient’s mismatch repair (MMR) status. MMR is a process that scans a person’s genetic code and fixes errors to prevent mutations that can lead to cancer. The test evaluates a panel of MMR proteins in tumours to provide this important treatment information to clinicians.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved Guardant360® CDx as a companion diagnostic (CDx) for Boehringer Ingelheim’s HERNEXEOS® (zongertinib tablets), the first targeted therapy for adults with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC) as an initial treatment option.

Danaher Corporation (NYSE: DHR), a global science and technology innovator, announced today that it has completed the acquisition of Masimo Corporation, a leading specialty diagnostics provider of pulse oximetry and other patient monitoring solutions, primarily in acute care treatment settings.