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The latest news on microsatellite instability testing.
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.
The company has multiple companion diagnostics partnerships in the works, with new tests on the way in 2020, and new plans for next-generation sequencing.
Novavax has begun a phase III trial of its SARS-CoV-2 vaccine, according to the New York Times.
Vox reports that the Trump Administration may limit student visas for individuals from some countries to two years.
The governor of New York says the state will conduct its own review of any SARS-CoV-2 vaccine, NPR reports.
This week in Science: Neanderthal Y chromosomes replaced by Homo sapiens Y chromosomes, and more.