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Thermo Fisher has also applied to the Japanese Ministry of Health, Labor, and Welfare to expand the use of the Oncomine Dx Target test in Japan.
The assay will identify patients with mutations in HER2 who may be eligible for treatment with a HER2-directed antibody-drug-conjugate developed by Daiichi.
Genetron's S5 sequencer is based on Thermo Fisher's Ion GeneStudio S5 instrument and is cleared for clinical use by China's NMPA.
Thermo will develop a test using its Oncomine Precision Assay to identify IDH1- and IDH2-positive low-grade glioma patients for treatment with Agios' vorasidenib.
The firm said as part of a development study it is using a gut microbiome analysis tool developed in collaboration with Thermo Fisher Scientific.
While the guidance may lead to more streamlined CDx indications in precision oncology, test developers will still need to generate evidence, perhaps with limited pharma support.
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.