FDA Clears NYU’s Cancer Genome Test

The FDA has granted 510(k) marketing clearance to a cancer gene sequencing test developed at New York University.

The NYU Langone Genome Profiling of Actionable Cancer Targets (PACT) test detects changes in the DNA code of 607 genes that have been linked to multiple types of cancer.

The PACT test uses sequencing to read the order of the molecular “letters” making up DNA code within hundreds of genes simultaneously.

The test was designed by molecular pathologists at NYU’s Langone Health Laura and Isaac Perlmutter Cancer Center to help guide treatment decisions for cancer patients.