FDA approves new liquid biopsy tests using NGS to detect tumor DNA, aiding targeted cancer therapy selection.

FDA Approves First Liquid Biopsies That Test for Mutations in Multiple Genes

The Food and Drug Administration (FDA) recently approved new tests to detect DNA circulating in the blood after being shed by cancerous tumors. These tests use advanced testing technology to provide genetic information about the tumors and tell whether specific cancer drugs may treat them.

In recent years, cancer drugs have been developed to target specific genetic changes (mutations) in tumors. Testing the tumor for the particular mutation that the drug targets can help predict who may benefit from the drug and who is not likely to respond.

Most often, this genetic (or biomarker) testing is done on tumor tissue collected during a traditional tissue biopsy that involves removing small pieces of tumor tissue through surgery, or in some cases a needle biopsy. The newly approved tests are blood tests and are commonly called liquid biopsies. They may be used alongside or as an alternative to invasive tissue biopsies. In general, liquid biopsies detect circulating free DNA or whole cells shed by tumors into the blood and require only a blood sample. They are especially useful when the location of a tumor makes it difficult or impossible to remove a sample for analysis. While tissue biopsies are the standard of care for diagnosing cancer, liquid biopsies may be acceptable for more frequent sampling to monitor cancer and guide treatment.

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