MSAC publishes agenda for upcoming meeting

3 September 2021 - 12 agenda items for consideration at the 25-26 November 2021 meeting. ...

Read more →

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.  ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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, ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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. ...

Read more →