Foundation Medicine Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for Eli Lilly and Company’s Retevmo (selpercatinib), which was approved by the FDA for the treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

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

Agilent Technologies Inc. (NYSE: A) today announced the signing of a Memorandum of Understanding (MOU) with the Sarawak Infectious Disease Centre (SIDC) in East Malaysia.

Today, Sanguina, Inc. (Sanguina), a leading biotech company, is pleased to announce the FDA clearance of AnemoCheck Home, the only FDA-cleared home hemoglobin test kit available in the United States.

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

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.