The move raises questions about what precisely is an LDT outside of FDA jurisdiction and heightens concerns that poorly validated tests will enter the market and endanger public health.
The agency approved the test for use across solid tumors and with multiple companion diagnostic indications including one for prostate cancer and three for lung cancer.
TargetCancer is activating two enrollment sites and setting up a remote consenting process so patients with rare cancers can be seen at local community hospitals.
A consortium convened by Friends of Cancer Research has made progress in quantifying sources of TMB assay discordance and created a new test-alignment software tool.
Analyzing both circulating tumor DNA and circulating tumor cells, investigators could classify patients into groups with significantly higher and lower recurrence risk.
