Guardant Health gets Medicare coverage for Guardant360 Response test

Guardant Health announced that Palmetto GBA, a Medicare administrative contractor for the Molecular Diagnostics Services program has conveyed coverage for the Guardant360 Response test. Guardant360 Response is the first blood-only test that enables doctors to track molecular response through changes in circulating tumor DNA levels, to get an early indication of metastatic or advanced cancer patient response to immune checkpoint inhibitor therapy. Following this decision, the Guardant360 Response test is now covered for fee-for-service Medicare patients in the U.S. with metastatic or inoperable solid tumors who are on an immune checkpoint inhibitor therapy. The coverage includes a Guardant360 CDx or LDT test before initiating therapy to establish a ctDNA baseline and a Guardant360 Response test 4 to 10 weeks after the therapy has been initiated to measure the change in ctDNA level. "We are pleased that Medicare has taken this important step to make treatment response monitoring more widely available in order to assist oncologists in making more informed therapeutic decisions for their patients with solid tumor cancers," said Helmy Eltoukhy, Guardant Health co-CEO.