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The authorization implements regulatory strategies the FDA advanced with industry stakeholders, though labs may still be more inclined to take the CLIA route, as long as it is available.
The agency said that its action on MSK IMPACT "advances a policy framework that paves the way for the efficient review and availability of other NGS-based cancer profiling tools."
Pathoquest will compare its iDtect blood test with standard testing methods to identify microbes causing infections in patients with febrile neutropenia.
Researchers will use the company's Colvera assay to track biomarkers in rectal cancer patients before, during, and after treatment.
The collaborations will evaluate whether patient-specific ex vivo cancer immunotherapy assays can predict in vivo efficacy, and ACEA's cell analysis platform.
More than a third of the first 10,000 patients receiving MSK-IMPACT harbored actionable mutations, and 11 percent of the first 5,000 enrolled in a clinical trial.
The lead investigators said that Foundation Medicine's NGS test will enable the beginning of targeted treatment within seven days of diagnosis.
Scientists at Memorial Sloan Kettering Cancer Center, led by Gabriela Chiosis, revealed how the complexes are important for tumor survival in certain cases.