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The latest news on microsatellite instability testing.
The new consortium is aiming to make comprehensive genomic profiling accessible to advanced cancer patients in the US, to help inform their treatment decisions.
Promega will develop its microsatellite instability assay as a companion diagnostic for Incyte's anti-PD-1 drug candidate retifanlimab in endometrial cancer.
The updated guidelines now also highlight the use of PCR and next-generation sequencing to determine microsatellite instability.
Promega will seek to expand use of the assay in Europe while it works through regulatory review of the test for companion diagnostic use in the US and Asia.
The drugmaker will cover the cost of testing for up to 500 patients in the US with MSI-high colorectal cancer or RAI-refractory differentiated thyroid cancer.
With TMB as a CDx, the drug will be available to more patients as a salvage option, but doctors will still need to consider the complex biomarker amid evolving research.
The Belgian diagnostics company said it has partnered with Bristol-Myers Squibb to register its MSI test as a companion diagnostic in China.
The groups have written draft recommendations and are now asking for public comment from pathologists and other stakeholders.
The company announced during its Q4 earnings call that it had acquired Paradigm Diagnostics and Viomics to fill out its expertise in cancer diagnostics.
The findings should spur cancer centers to review testing rates and address barriers, said experts from Hackensack University, Cota Healthcare, and Guardant Health.