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RSS FeedPosted 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 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 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 ...
Posted by Michael Wonder on 20 Nov 2023
US FDA approves FoundationOne CDx as a companion diagnostic for AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) to identify patients with HR positive, HER2 negative advanced breast cancer
20 November 2023 - Foundation Medicine today announced that it has received approval from the US FDA for FoundationOne CDx ...
Posted by Michael Wonder on 10 Oct 2023
US FDA approves FoundationOne CDx as a companion diagnostic for Lilly’s Retevmo (selpercatinib) for certain patients with solid tumours
9 October 2023 - Foundation Medicine’s tissue based comprehensive genomic profiling test is now FDA approved to identify patients with ...
Posted by Michael Wonder on 07 Oct 2023
EntroGen receives FDA approval for CRCdx RAS mutation detection kit as companion diagnostic for Vectibix
3 October 2023 - The US FDA has granted approval for EntroGen's CRCdx RAS Mutation Detection Kit as a companion diagnostic ...
Posted by Michael Wonder on 15 Aug 2023
US FDA approves FoundationOne CDx as a companion diagnostic for Janssen’s Akeega (niraparib and abiraterone acetate dual action tablet) for patients with BRCA positive metastatic castration-resistant prostate cancer
14 August 2023 - Foundation Medicine’s tissue-based comprehensive genomic profiling test is now FDA approved to identify patients with metastatic castration-resistant ...
Posted by Michael Wonder on 07 Aug 2023
Qiagen receives FDA approval for companion diagnostic to Blueprint Medicines’ Ayvakit (avapritinib) in gastro-intestinal stromal tumours
7 August 2023 - QIAGEN’s therascreen PDGFRA RGQ PCR kit approved in US to aid in identifying patients with unresectable or ...
Posted by Michael Wonder on 22 Jul 2023
Invivoscribe announces FDA approval of the LeukoStrat CDx FLT3 mutation assay to select patients with FLT3 ITD positive AML for treatment with Vanflyta
21 July 2023 - Invivoscribe is excited to announce that the LeukoStrat CDx FLT3 mutation assay has been approved by ...
Posted by Michael Wonder on 30 Jun 2023
FDA approves ARUP Laboratories' AAV5 DetectCDx, a first-ever companion diagnostic immunoassay for a gene therapy
29 June 2023 - FDA issues simultaneous approval of Roctavian (valoctocogene roxaparvovec-rvox), BioMarin's gene therapy for severe haemophilia A. ...
Posted by Michael Wonder on 20 Jun 2023
FDA launches pilot program to help reduce risks associated with using laboratory developed tests to identify cancer biomarkers
20 June 2023 - Pilot geared toward sponsors of certain oncology drug products used with certainin vitro diagnostic tests ...
Posted by Michael Wonder on 09 Jun 2023
US FDA approves FoundationOne Liquid CDx as a companion diagnostic for Pfizer’s Braftovi (encorafenib) in combination with cetuximab to identify patients with BRAF V600E alterations in metastatic colorectal cancer
9 June 2023 - Foundation Medicine today announced that it has received approval from the US FDA for FoundationOne Liquid ...