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The agency granted the NDA priority review, putting the application on a six-month review clock, instead of the 10-month standard review time frame.
By combining with ArcherDX, Invitae will gain tumor profiling and liquid biopsy technologies for predicting and monitoring therapeutic response.
ArcherDX said the firms aim to apply minimal residual disease monitoring in clinical-trial protocols and for future therapy optimization.
ArcherDx will develop sequencing-based circulating tumor DNA assays for use in AstraZeneca's recently launched Phase III MERMAID-1 trial of durvalumab (Imfinzi).
The firms are developing a kit-based CDx to detect NTRK gene fusions, including NTRK1, NTRK2 and NTRK3, for Bayer's Vitrakvi cancer treatment.
The firms will evaluate Stratafide, a pan-solid tumor diagnostic test designed to identify actionable genomic alterations in tissue or blood samples.
The drug, tepotinib, will now be available to treat advanced non-small cell lung cancer patients in Japan with MET exon 14 skipping alterations.
The partners are working together to advance tests that will identify which cancer patients have Notch activating mutations and fusions.