Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 05 Nov 2020
PASC to consider methods for the detection of beta amyloid pathology in patients with early stage Alzheimer's disease to determine eligibility for aducanumab
4 November 2020 - The application from Biogen has requested consideration of two alternative methods for the detection of the presence ...
Posted by Michael Wonder on 29 Oct 2020
Roche receives FDA approval for the cobas EGFR Mutation Test v2 as the first companion diagnostic test for expanded EGFR TKI therapies in patients with non-small cell lung cancer
29 October 2020 - The new FDA approval allows the test to be used as a companion diagnostic for a broad ...
Posted by Michael Wonder on 27 Oct 2020
FDA approves new FoundationOne Liquid CDx companion diagnostic indications for three targeted therapies that treat advanced ovarian, breast and non-small cell lung cancer
27 October 2020 - Foundation Medicine today announced that the U.S. FDA approved FoundationOne Liquid CDx for three new companion ...
Posted by Michael Wonder on 24 Oct 2020
FDA approves FoundationOneCDx as companion diagnostic for Vitrakvi (larotrectinib) to aid in identifying NTRK fusion positive patients
23 October 2020 - Detection of genomic alterations that drive the growth and spread of the tumour can guide treatment decisions ...
Posted by Michael Wonder on 08 Sep 2020
Roche Canada announces FoundationOne Liquid CDx now available in Canada
8 September 2020 - Comprehensive pan-tumour liquid biopsy test analyzes >300 cancer-associated genes and multiple genomic signatures to inform treatment choices. ...
Posted by Michael Wonder on 08 Sep 2020
FDA approves first NGS-based companion diagnostic for RET fusion positive non-small cell lung cancer
8 September 2020 - CDx approval expands clinical utility of Oncomine Dx Target Test to identify candidates for Gavreto. ...