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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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MSAC publishes agenda for April MSAC meeting

22 November 2023 - The MSAC Secretariat has published a list of applications scheduled to be considered by the MSAC on ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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