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The companies initially plan to validate biomarkers for use with the Oncomine Dx Target Test to identify NSCLC patients for enrollment into clinical trials.
The high-throughput S2000 sequencer is the second instrument Genetron Health has received NMPA approval for, following the S5 benchtop instrument last year.
As labs implement TMB workflows in-house, studies are showing that its is possible to validate assays with cutoff points remaining stable across complex clinical cohorts and in different drug contexts.
The firms plan to use Thermo Fisher's Oncomine Dx Target test to identify cancer patients with RET alterations who might benefit from Lilly's LOXO-292.
At the NCI's Childhood Cancer Data Initiative Symposium, speakers emphasized measures such as data harmonization and the need for longitudinal data collection.
The assays will combine genomic and gene expression analyses to better understand driver mutations in prostate, breast, and pancreatic cancers.
The DoD and VA-led initiative is moving beyond its initial focus on lung cancer to add analyses of multiple cancer types and a prospective, multisite study.
The test relies on a signature that Almac developed for stratifying breast cancer patients, but which, as the researchers showed, can be used in other cancers as well.
The NGS assay is designed to help physicians to identify non-small cell lung cancer patients who may benefit from eight targeted therapies.
The draft guidelines have intrigued industry players interested in pursuing labeling that would allow their CDx to direct treatment for a class of drugs instead of one drug.