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Two recent acquisitions have resulted in the swift launch of two assays, one for the clinic and another for research use, as the firm's original test finally nears validation.
The drug, tepotinib, will now be available to treat advanced non-small cell lung cancer patients in Japan with MET exon 15 skipping alterations.
The companies initially plan to validate biomarkers for use with the Oncomine Dx Target Test to identify NSCLC patients for enrollment into clinical trials.
LabCorp will be the exclusive provider of the test, which uses next-generation sequencing to look for actionable mutations cell-free DNA in NSCLC patients.
The high-throughput S2000 sequencer is the second instrument Genetron Health has received NMPA approval for, following the S5 benchtop instrument last year.
The funds will support the companies' efforts to develop tests for predicting NSCLC patients' response to immunotherapy.
The companies will develop tissue-based companion diagnostics for Amgen's investigational treatment AMG 510 for non-small cell lung cancer.
The company plans to submit a companion diagnostic version of its sequencing-based liquid biopsy test Guardant360 to various regulatory bodies.
The approval will allow clinicians to identify NSCLC patients with ROS1 fusion genes who could benefit from treatment with Rozlytrek.
Palmetto has expanded the local coverage determination for the Guardant360 liquid biopsy assay to be used with the majority of advanced solid tumors.