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RSS FeedPosted 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. ...
Posted by Michael Wonder on 27 Jul 2022
MSAC publishes agenda for November 2022 meeting
27 July 2022 - 12 agenda items for consideration at the 24-25 November 2022 meeting. ...
Posted by Michael Wonder on 07 Jul 2022
EMA finalises companion diagnostic guidance
7 July 2022 - The EMA) has finalised guidance on companion diagnostics, addressing procedural aspects to facilitate consultation between EMA ...
Posted by Michael Wonder on 30 Mar 2022
MSAC publishes agenda for July 2022 meeting
30 March 2022 - 12 agenda items for consideration at the 28-29 July 2022 meeting. ...
Posted by Michael Wonder on 17 Mar 2022
U.S. FDA approves FoundationOne CDx as a companion diagnostic for EGFR therapeutics targeting exon 19 deletions or exon 21 substitutions in non-small cell lung cancer
17 March 2022 - Foundation Medicine’s tissue-based test is the first and only comprehensive genomic profiling test to be approved ...
Posted by Michael Wonder on 12 Mar 2022
Myriad Genetics receives FDA approval of BRACAnalysis CDx as a companion diagnostic for Lynparza in early breast cancer
11 March 2022 - BRACAnalysis CDx is now the only germline test approved by FDA as a companion diagnostic for treatment ...
Posted by Michael Wonder on 21 Feb 2022
U.S. FDA approves FoundationOne CDx as a companion diagnostic for Keytruda (pembrolizumab) to identify patients with microsatellite instability-high solid tumours
21 February 2022 - Foundation Medicine’s tissue-based comprehensive genomic profiling test is now the first and only FDA approved companion diagnostic ...
Posted by Michael Wonder on 12 Dec 2021
FDA approves NGS based companion diagnostic for EGFR exon20 insertion mutant non-small-cell lung cancer tumour tissue
9 December 2021 - Oncomine Dx Target Test now approved for 12 NSCLC targeted therapies globally. ...
Posted by Michael Wonder on 25 Nov 2021
MSAC publishes agenda for upcoming meeting
24 November 2021 - 10 agenda items for consideration at the 31 March - 1 April 2022 meeting. ...