Guardant Health has received an expanded Medicare local coverage determination for its Guardant360 liquid biopsy test, broadening its coverage to all solid tumors outside of the central nervous system.
The policy makes the blood test available for all fee-for-service Medicare patients with advanced cancer who would otherwise receive complete genomic profiling of their tumor but have insufficient tissue available or are unable to undergo a traditional biopsy exam. According to Guardant, tissue insufficiency can be a hurdle to as many as 30% of advanced cancer patients.
“Unfortunately, too many patients today are not tested for the key guideline-recommended biomarkers needed to make targeted treatment decisions,” Guardant CEO Helmy Eltoukhy said in a statement. “This is a critical issue as response rates can be two to three times better using targeted therapies compared to chemotherapy and significantly higher than immunotherapy.”
In addition, the coverage determination—handed down by Palmetto GBA, an administrative contractor for Medicare’s molecular diagnostics program—also covers blood testing for patients who have seen their cancer progress after initial therapy to help guide them toward new treatment options based on newly acquired tumor mutations.
Earlier this year, Guardant presented a study demonstrating that its test beat out traditional tissue biopsy head to head in non-small cell lung cancer. The circulating cell-free DNA test delivered similar results faster and with more accuracy across a slate of predictive genomic biomarkers.
A separate study later showed how Guardant360 can track a patient’s microsatellite instability status on par with solid tissue testing, which can help predict responses to immunotherapy.
With the new Medicare decision and previous coverage from private insurance companies, Guardant estimates Guardant360 is available as a covered test for more than 150 million people in the U.S.