MSAC publishes agenda for July 2022 meeting

30 March 2022 - 12 agenda items for consideration at the 28-29 July 2022 meeting. ...

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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 ...

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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 ...

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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 ...

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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. ...

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MSAC publishes agenda for upcoming meeting

24 November 2021 - 10 agenda items for consideration at the 31 March - 1 April 2022 meeting. ...

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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.  ...

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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 ...

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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 ...

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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 ...

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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 ...

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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, ...

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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 ...

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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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