Chinese molecular diagnostic firm Dinfectome said on Monday that its DIFSeq-200 sequencer has obtained approval from the Chinese National Medical Products Administration (NMPA).

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 AstraZeneca’s Truqap™ (capivasertib) in combination with Faslodex® (fulvestrant) which has been contemporaneously approved for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

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

Siemens Healthineers said Monday that it has secured a three-year, $5.5 million contract with the National Institute of Allergy and Infectious Diseases to develop a next-generation sequencing-based test to guide antimicrobial treatments in sepsis patients.

Agilent Technologies Inc. (NYSE: A) today reported revenue of $1.69 billion for the fourth quarter ended Oct. 31, 2023, a decline of 8.7% reported and 9.7% core(1) compared to the fourth quarter of 2022.

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

Transplant diagnostic firm Verici DX and Thermo Fisher Scientific have signed an exclusive global licensing and commercialization agreement to develop a pre-transplant prognostic test for early kidney rejection risk assessment.

The US Food and Drug Administration said Thursday that it has granted Roche Emergency Use Authorization for a new version of its multiplex molecular assay for detecting SARS-CoV-2 and influenza A/B.

The US Food and Drug Administration (FDA) has approved LetsGetChecked’s at-home testing system for chlamydia and gonorrhoea.

Roche announced on Thursday it received CE marking for two serology tests for hepatitis E.

Sansure Biotech has achieved a milestone in the field of immunodiagnostics, marking significant progress in international strategic expansion. On the evening of November 14, Sansure Biotech announced that its automated chemiluminescence immunoassay (CLIA) systems recently received the EU CE IVDR certification.

Foundation Medicine, Inc., and Pierre Fabre Laboratories today announced a collaboration to develop Foundation Medicine’s high-quality genomic tests, FoundationOne®CDx and FoundationOne®Liquid CDx, as companion diagnostics for new targeted therapies to treat patients with non-small cell lung cancer (NSCLC).

As of 31 October 2023, over 50 Chinese IVD listed companies have announced their Q3 financial results.

Biotech company AnchorDx has entered into a long-term partnership with molecular diagnostics firm DiaCarta to develop and commercialize cancer diagnostic products for the global market.

Agilent Technologies on Tuesday said it gained US Food and Drug Administration approval of the firm's PD-L1 companion diagnostic assay for use in identifying gastric or gastroesophageal junction adenocarcinoma patients for a combination treatment with Merck's Keytruda (pembrolizumab) checkpoint inhibitor.