Blog
RSS FeedPosted 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 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 ...
Posted by Michael Wonder on 20 Dec 2022
Qiagen receives FDA approval for companion diagnostic to Mirati Therapeutics’ Krazati in non-small-cell lung cancer
13 December 2022 - therascreen KRAS RGQ PCR kit approved as a companion diagnostic to aid in identifying non-small-cell lung cancer ...
Posted by Michael Wonder on 14 Dec 2022
Agilent Resolution ctDx First receives FDA approval as a liquid biopsy companion diagnostic test for advanced non-small-cell lung cancer
12 December 2022 - Agilent Technologies announced today that the US FDA has approved Agilent Resolution ctDx First as a ...
Posted by Michael Wonder on 04 Oct 2022
Roche receives FDA approval for first companion diagnostic to identify patients with HER2 low metastatic breast cancer eligible for Enhertu
4 October 2022 - Approximately half of all patients with metastatic breast cancer express low levels of HER2. ...