Blog
RSS FeedPosted by Michael Wonder on 19 Mar 2026
Myriad Genetics receives FDA approval of the MyChoice CDx test as the companion diagnostic for Zejula (niraparib) for patients with ovarian cancer
17 March 2026 - Approval reinforces Myriad’s leadership in comprehensive HRD testing and establishes MyChoice CDx as the only FDA-approved ...
Posted by Michael Wonder on 13 Feb 2026
Agilent receives FDA approval for PD-L1 IHC 22C3 pharmDx in epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
11 February 2026 - Approval expands PD-L1 testing to support treatment decisions with Keytruda (pembrolizumab). ...
Posted by Michael Wonder on 23 Jan 2026
Guardant Health receives FDA approval for Guardant360 CDx as companion diagnostic for Braftovi (encorafenib) combination in patients with BRAF V600E mutant metastatic colorectal cancer
22 January 2026 - Approval supported by data from Pfizer’s BREAKWATER trial demonstrating improved outcomes in BRAF V600E-mutant metastatic colorectal cancer ...
Posted by Michael Wonder on 21 Jan 2026
Truqap faces double barrier in Korea as NGS and drug reimbursement lag
20 January 2026 - As demand for next generation sequencing screening rises, a new drug for metastatic breast cancer faces ...
Posted by Michael Wonder on 13 Nov 2025
FDA approves Promega OncoMate MSI Dx analysis system as companion diagnostic for Keytruda in combination with Lenvima in advanced endometrial carcinoma
11 November 2025 - The US FDA has approved the Promega OncoMate MSI Dx Analysis System as a companion diagnostic designed ...
Posted by Michael Wonder on 30 Sep 2025
FDA approves Guardant360 CDx as companion diagnostic for Eli Lilly and Company’s Inluriyo (imlunestrant) for treatment of ESR1 mutated advanced breast cancer
29 September 2025 - This marks the second FDA approved indication for Guardant360 CDx as a companion diagnostic in breast cancer ...
Posted by Michael Wonder on 03 Feb 2025
Roche receives FDA approval for the first companion diagnostic to identify patients with HER2 ultralow metastatic breast cancer eligible for Enhertu
31 January 2025 - The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2 low ...
Posted by Michael Wonder on 28 Nov 2024
US FDA approves FoundationOne Liquid CDx as a companion diagnostic for Tepmetko (tepotinib) to identify patients with MET exon 14 skipping alterations in non-small cell lung cancer
18 November 2024 - FoundationOne Liquid CDx is the first FDA approved companion diagnostic to identify patients who may be ...
Posted by Michael Wonder on 09 Nov 2024
Caris Life Sciences receives FDA approval for MI Cancer Seek as a companion diagnostic test
6 November 2024 - MI Cancer Seek is the first and only simultaneous whole exome and whole transcriptome-based assay with ...
Posted by Michael Wonder on 05 Sep 2024
US FDA approves FoundationOne CDx and FoundationOne Liquid CDx as companion diagnostics for Lynparza (olaparib) in combination with abiraterone for patients with BRCA mutated metastatic castration-resistant prostate cancer
3 September 2024 - Foundation Medicine’s tissue and liquid biopsy tests can now be used to identify more patients who could ...
Posted by Michael Wonder on 30 May 2024
Improving our assessments of drugs with companion diagnostic tests
30 May 2024 - As part of our ongoing initiative to improve and modernise our reimbursement review program, Canada’s Drug Agency ...
Posted by Michael Wonder on 25 May 2024
FDA Advisory Committee Panel strongly recommends approval of Shield blood test for colorectal cancer screening as a primary non-invasive screening option
23 May 2024 - Shield remains on track to become the first FDA approved blood test that meets performance requirements for ...
Posted by Michael Wonder on 17 May 2024
Health Canada approves Saladax’s 5-fluorouracil chemotherapy therapeutic drug monitoring test
14 May 2024 - Saladax Biomedical is pleased to announce that Health Canada has approved Saladax’s 5-Fluorouracil (My5-FU) Assay for sale ...
Posted by Michael Wonder on 10 May 2024
Tests could lead to fewer people having unnecessary chemotherapy after surgery for early breast cancer
10 May 2024 - More people with early breast cancer could be spared chemotherapy and therefore avoid the side effects associated ...
Posted by Michael Wonder on 02 May 2024
Labcorp receives FDA approval for first companion diagnostic for use with Pfizer's newly approved gene therapy to treat patients with haemophilia B
29 April 2024 - Labcorp today announced the U.S. FDA has approved its nAbCyte Anti-AAVRh74var HB-FE Assay, a companion diagnostic to ...