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The company reported that its genome-wide methylation approach could detect 77 percent of stage II cancers in its ongoing case-control CCGA study.
Olaparib maintenance therapy stretched out progression-free survival, suggesting a need for germline BRCA1/2 mutation testing in pancreatic cancer patients.
Thrive Earlier Detection is banking on targeted detection of frequent cancer mutations, coupled with protein markers, while competitors turn to genome-wide approaches.
The actual match rate is significantly higher than the 10 percent rate the researchers anticipated they would see when the study began in 2017.
In the Phase I/IB study, only patients with NTRK or ROS1 fusions, or an ALK fusion or mutation responded to entrectinib, while patients without these tumor markers didn’t respond.
The diversity of the organizations that have signed the letter to CMS demonstrates widespread concern over this policy.
The company believes that helping to funnel patients to the trial will help support its own goals to gather genomic information on targeted cancer therapy efficacy.
The company highlighted growth in demand for its test , and is now ramping up marketing and focusing on its IVD development plans.
The company is planning to submit the drug and a companion diagnostic that can identify patients with FGFR alterations with the FDA in the second half of 2018.
A new trial has compared the two most prominent tests, showing that both have clear predictive ability, but leaving several other questions unanswered so far.