Recently, Autobio's hepatitis B virus surface antigen (HBsAg) detection kit (magnetic particle chemiluminescence method) successfully passed the European clinical assessment and obtained the first EU CE IVDR Class D certification in China.

Thermo Fisher Scientific said on Wednesday that it has obtained US Food and Drug Administration clearance for its BRAHMS CgA II KRYPTOR test, a chromogranin A (CgA) immunoassay for assessing tumor progression in gastroenteropancreatic neuroendocrine tumor (GEP-NET) patients.

In 2023, NHC and 10 other departments issued the Action Plan Towards the Elimination of Cervical Cancer (2023-2030). The goal is that by 2025, HPV vaccination services for girls of school age will be promoted on a pilot basis, the cervical cancer screening rate for women of school age will reach 50%, and the treatment rate for patients with cervical cancer and precancerous lesions will reach 90%.

Cell Signaling Technology (CST), a life science discovery technology company and leading provider of antibodies, kits, and services, is partnered with Leica Biosystems, a technology leader in automated staining and brightfield and fluorescent imaging, to support the development of companion diagnostics (CDx) assays using the extensive portfolio of best-in-class antibodies from CST validated for immunohistochemistry (IHC).

Through MDUFA V, the FDA committed to several international harmonization initiatives and secured additional resources to support the work. The publication of a draft strategic plan was the first item on the MDUFA V convergence and reliance agenda.

China Association of In Vitro Diagnostics (CAIVD) and In Vitro Diagnostics Society of China Association for Medical Devices Industry jointly compiled this report.

Despite concerns from researchers and organizations, the U.S. National Institutes of Health (NIH) is adamant about implementing its new mandate requiring foreign partners to share raw data and notebooks at regular set intervals with their primary U.S. grant recipient, releasing its final guidance on September 15.

Streck announced on Monday that its MDx-Chex quality controls have received clearance from the US Food and Drug Administration.

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

Medtronic has received a CE mark for its continuous glucose monitoring (CGM) device, Simplera, allowing the device to be marketed in the European Union.

Abbott (NYSE: ABT) today announced it has completed the acquisition of Bigfoot Biomedical, a leader in developing smart insulin management systems for people with diabetes.

As the demand for the mass spectrometry market in China has rapidly increased, major domestic and international mass spectrometer manufacturers have accelerated their product registration efforts. In recent years, a variety of different types of mass spectrometry instruments have obtained NMPA certificates.

A systematic review of earlier studies has found that artificial intelligence (AI) and machine learning (ML) can support the diagnosis of polycystic ovarian syndrome (PCOS).

QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, announced today that it has been granted CLIA Waiver from the U.S. Food and Drug Administration (FDA), applying to its new Sofia® 2 SARS Antigen+ FIA.

Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, today announced two key milestones in its strategic partnership with Illumina Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, to advance and support clinical research for gene-based, targeted therapies.