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RSS FeedPosted 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. ...
Posted by Michael Wonder on 19 Aug 2021
EndoPredict for breast cancer - the company chose not to participate with data
19 August 2021 - In November 2020, Myriad Genetics chose to refrain from participating in a health economic assessment of EndoPredict. ...
Posted by Michael Wonder on 19 Aug 2021
Roche receives FDA approval for first companion diagnostic to identify dMMR solid tumour patients eligible for anti-PD-1 immunotherapy
19 August 2021 - Based on cancer biomarkers, the first-of-its-kind VENTANA MMR RxDx Panel helps determine which solid tumour patients may ...
Posted by Michael Wonder on 18 Aug 2021
AmoyDx Pan lung cancer PCR panel receives MHLW approval as companion diagnostic for Tepmetko (tepotinib)
17 August 2021 - Riken Genesis, Amoy Diagnostics and Precision Medicine Asia today announced that the Ministry of Health, Labour ...
Posted by Michael Wonder on 17 Aug 2021
Tempus submits PMA application to the FDA for its xT-Onco assay
17 August 2021 - Tempus today announced the submission of a premarket approval application for its proprietary broad-panel DNA sequencing ...
Posted by Michael Wonder on 14 Aug 2021
Genomic diagnostic tests face persistent pricing and reimbursement challenges
13 August 2021 - Twenty years ago, the mapping of the human genome promised new opportunities for genomic or genetic tests ...
Posted by Michael Wonder on 10 Aug 2021
Companion diagnostics are growing rapidly worldwide. What about in Korea?
10 August 2021 - The global companion diagnostics market is expanding fast, but Korea has yet to develop related technologies, ...
Posted by Michael Wonder on 23 Apr 2021
Roche receives FDA approval for first companion diagnostic to identify endometrial cancer patients eligible for immunotherapy
23 April 2021 - VENTANA MMR RxDx Panel is the first immunohistochemistry predictive test in endometrial cancer for treatment with the ...
Posted by Michael Wonder on 15 Nov 2020
Agilent receives expanded FDA approval for PD-L1 IHC 22C3 pharmDx in triple negative breast cancer
13 November 2020 - Announcement marks the seventh cancer type for which PD-L1 IHC 22C3 pharmDx has gained approval in the ...
Posted by Michael Wonder on 09 Nov 2020
FDA approves liquid biopsy NGS companion diagnostic test for multiple cancers and biomarkers
9 November 2020 - On 6 November, the FDA approved the FoundationOne Liquid CDx test as a companion diagnostic device to ...