NEW YORK — Guardant Health said on Tuesday that its Guardant360 Response liquid biopsy test for monitoring patient responses to immune checkpoint inhibitors has received a positive Medicare coverage decision from Palmetto GBA, a Medicare administrative contractor through the Molecular Diagnostics Services program.
Following the news, SVB Securities Analyst Puneet Souda said that the coverage decision is unlikely to have any significant impact on Guardant's clinical testing volumes this year. That should change going forward as Guardant360 Response adds to the growing traction for the company's reimbursed assays, Souda wrote in a note to investors.
Guardant360 Response is designed to track circulating tumor DNA (ctDNA) levels in blood samples, enabling clinicians to evaluate how a patient is responding to treatment.
With the decision, the test is now covered for fee-for-service Medicare patients in the US with metastatic or inoperable solid tumors who are on an immune checkpoint inhibitor therapy, Palo Alto, California-based Guardant said. The coverage includes a Guardant360 CDx companion diagnostic or lab-developed test before initiating therapy to establish a ctDNA baseline, as well as a Guardant360 Response test four to 10 weeks after the therapy has been initiated to measure the change in ctDNA level.
The test will be reimbursed at $3,500.
Guardant360 Response was launched in mid-2021 as part of Guardant's broader Guardant360 line of liquid biopsy assays, which now also includes Guardant360, Guardant360 CDx, Guardant360 TissueNext, and GuardantInfinity tests for advanced-stage cancer patients and Guardant Reveal for early-stage cancer patients.
In late 2019, Palmetto GBA expanded its local coverage determination for Guardant360, making the test the first liquid biopsy to be covered for use across most solid tumors. In 2022, Palmetto GBA extended coverage to Guardant360 TissueNext and Guardant Reveal.