Cell Signaling Technology (CST), a life science biotechnology company and leading provider of antibodies, kits, and services, and Amoy Diagnostics Co., Ltd. (AmoyDx), a China-based innovative molecular diagnostics company in the field of precision oncology, announced today the expansion of their ongoing partnership for companion diagnostic (CDx) development in China.

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.

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).

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.

ARUP Laboratories said Friday its companion diagnostic to help identify which patients are eligible for treatment with a gene therapy for hemophilia A received CE marking under the European Union's In Vitro Diagnostics Regulation (IVDR).

On October 25, 2023, during the 2023 Boehringer Ingelheim China R&D Day event, Burning Rock and Boehringer Ingelheim officially signed the Master Service Agreement (MSA) in the field of oncology companion diagnostics.

Werfen announced recently that its subsidiary Inova Diagnostics has secured US Food and Drug Administration 510(k) clearance for a blood-based immunoassay reagent used to aid the diagnosis of connective tissue diseases.

Abbott's RealTime IDH1 Assay has received approval from the US Food and Drug Administration as a companion diagnostic for Servier Pharmaceuticals' Tibsovo (ivosidenib) in patients with relapsed or refractory myelodysplastic syndrome, the FDA announced on Tuesday.

Foundation Medicine announced on Monday that it is expanding its partnership with Sequanta Technologies to provide its genomic profiling tests for research and oncology therapy development in China.

Thermo Fisher Scientific and Boehringer Ingelheim said on Thursday that they have partnered to develop companion diagnostic tests to help identify patients with non-small cell lung cancer (NSCLC) with specific mutations who may benefit from emerging targeted therapies.