Guardant360 covers all somatic guideline-recommended genomic biomarkers for advanced solid tumors / Guardant Health

Just over a week after Guardant Health announced they’d raised $360M in funding, their plasma-based genomic test Guardant360 is back in the news with the announcement that Medicare contractor, Palmetto GBA, is proposing a limited coverage policy. Should the draft be accepted, it would provide coverage with certain patients with advanced, non-small cell lung cancer.

Guardant360 is a form of liquid biopsy testing, which uses a patient’s blood to detect cell-free DNA for the diagnosis or monitoring of cancer. It’s been found to be a much less invasive monitoring technique than traditional tissue biopsies, which require surgery to obtain the necessary samples and may be impossible for certain forms of cancer. However, liquid biopsies have also demonstrated analytical challenges for clinicians, largely due to the much lower concentration of DNA in blood samples in comparison to tissue. These analytical challenges have been recognised in Palmetto’s draft, but the company believes that the test demonstrates sufficient performance to meet their standards.

The proposal limits the test to patients who are at stage IIIB or higher and are ineligible for traditional tissue-based genomic testing. It would also be unavailable to any patients who have already received genomic testing for EGFR alterations, ALK and ROS1 rearrangements, or PD-L1 expression. Medicare does not support repeat testing for therapeutic monitoring, so this would also not be covered under the draft.

Should the draft be accepted, any continual coverage would be subject to annual reviews on the efficacy and safety of the test.

“This is an important development to help ensure that Medicare patients with advanced lung cancer can access less toxic, effective targeted treatments,” said Helmy Eltoukhy, Co-Founder and CEO of Guardant Health. “Often patients endure the safety risks and pain of invasive lung biopsies, at considerable cost to the healthcare system, without getting sufficient tissue for comprehensive genomic profiling. For patients who are progressing on a treatment that’s no longer effective, Guardant360 can provide critical molecular information for treatment decisions without the safety risk of an invasive biopsy.”