The company has previously offered its liquid biopsy tests through an LDT model but sees the timing and the clinical niche as right for a regulatory bid in CSF testing.
Medicare patients on FDA-approved cancer treatments in the real world do not live as long as patients in pivotal clinical trials, according to an MSK analysis.
The final decision includes some changes, most notably removing requirements for guideline inclusion, but retains its technical performance benchmarks.
The agency issued a new draft decision memo, outlining various criteria it intends to apply when determining coverage for current and future blood-based CRC screening tests.
The pandemic has underscored the importance of "bringing the trial to the patient," a concept that is likely to persist, particularly in precision oncology.
The final national coverage decision stipulates that NGS germline tests for assessing hereditary breast and ovarian cancer risk must have FDA's blessing.
The LCD will provide coverage for the Decipher Prostate Biopsy genomic test for men with both favorable and unfavorable intermediate-risk prostate cancer.
