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 ...

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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 ...

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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 ...

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MSAC publishes agenda for upcoming meeting

30 October 2020 - 16 agenda items for 26-27 November 2020 meeting. ...

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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 ...

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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 ...

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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 ...

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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. ...

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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. ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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