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RSS FeedPosted 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 02 Nov 2020
MSAC publishes agenda for upcoming meeting
30 October 2020 - 16 agenda items for 26-27 November 2020 meeting. ...
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. ...
Posted by Michael Wonder on 24 Aug 2020
FDA's convalescent plasma EUA requires all donor blood units be tested only with Ortho's COVID-19 IgG antibody test
24 August 2020 - In its August 23 Emergency Use Authorisation for COVID-19 convalescent plasma for the treatment of hospitalised ...
Posted by Michael Wonder on 07 Aug 2020
FDA approves first liquid biopsy next generation sequencing companion diagnostic test
7 August 2020 - Today, the U.S. Food and Drug Administration approved the first liquid biopsy companion diagnostic that also uses ...
Posted by Michael Wonder on 28 Jan 2020
CMS expands coverage of next generation sequencing as a diagnostic tool for patients with breast and ovarian cancer
27 January 2020 - Final decision provides new access to Next Generation Sequencing tests for certain Medicare patients with cancer ...
Posted by Michael Wonder on 10 Jul 2019
Biomarker-based cancer diagnostics: German pricing regulator sets high validation and reimbursement standards for novel diagnostic methods
10 July 2019 - On 20 June 2019, for the first time, the German Federal Joint Committee (G-BA), made the resolution ...
Posted by Michael Wonder on 06 Dec 2018
Statement from FDA Commissioner on the FDA’s new effort for developing and class labelling of in vitro companion diagnostics for classes of oncology therapeutic products
6 December 2018 - One challenge we face right now, when it comes to developing diagnostics that can help target ...
Posted by Michael Wonder on 04 Dec 2018
FDA takes new action to advance the development of reliable and beneficial genetic tests that can improve patient care
4 December 2018 - The U.S. FDA today took a significant step forward in driving the efficient development of novel diagnostic ...