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NYU Langone Health Gets FDA Clearance for Solid Tumor Gene Sequencing Test

NEW YORK — NYU Langone Health said on Thursday that it has received 510(k) clearance from the US Food and Drug Administration for its Genome PACT genetic test for solid tumors.

Genome PACT — short for profiling of actionable cancer targets — uses next-generation sequencing to detect cancer-linked mutations in 607 genes in tumor cells in order to match patients with approved treatments targeting their specific disease-causing mutations.

The test was developed in collaboration with healthcare tech firm Philips, which helped build an interface between the test and NYU Langone Health's electronic medical records system. It is currently only FDA-cleared for use in patients at NYU Langone Health.

"The FDA decision on PACT reaffirms the goal behind its design, which was to provide our patients with the best understanding of the genetic changes driving their cancers," NYU Langone Health's Matija Snuderl, who designed the test, said in a statement. "Knowing the genetics of their tumor can help to determine which therapies will work for a given patient and their eligibility for specific clinical trials."