Roche subsidiary Foundation Medicine announced on Thursday that the US Food and Drug Administration has approved two of its companion diagnostic tests for use with Pfizer's Braftovi (encorafenib) in combination with Mektovi (binimetinib) for patients with metastatic non-small cell lung cancer with a BRAF V600E mutation.

U.S. genetic testing company Illumina (ILMN.O) has been ordered by EU antitrust regulators to sell cancer test maker Grail (GRAL.O) after it completed the deal before securing their approval.

As more and more medical technologies are being built on artificial intelligence and machine learning, the FDA is enlisting a new panel of outside experts to help it get deeper into the weeds.

Labcorp (LH.N) on Wednesday began marketing to U.S. physicians the first test for a trio of blood biomarkers it says can detect the hallmarks of Alzheimer's, accelerating diagnosis of the brain-wasting disease and potentially helping patients access treatment.

As of the end of June 2023, the number of valid registrations and filings of medical devices nationwide reached 301,639, an increase of 18.12% compared with the same period of last year, with 46,283 new cases, an increase of 7.25% compared with the end of 2022 (281,243 cases).

Laboratory services provider Stone Diagnostics will offer Fibronostics' artificial intelligence-based liver disease test to physicians in the US, the companies announced on Tuesday.

Fujirebio Holdings, Inc. (HQ: Minato-ku, Tokyo; President & CEO: Goki Ishikawa) and Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano) announce that they have entered into a Basic Agreement on Business Collaboration to deepen their multifaceted collaboration, such as on research and development, production, clinical development, and sales-marketing, in the field of immunoassay.

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

Invitae (NYSE: NVTA), a leading medical genetics company, today announced it gained FDA market authorization for its Common Hereditary Cancers Panel.

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.