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Guardant Health Liquid Biopsy Test Gets Expanded Medicare Coverage for Solid Tumors

NEW YORK – Guardant Health announced Thursday that its Guardant360 liquid biopsy test has received expanded Medicare coverage across a dozen solid tumor types. 

Palmetto, the administrative contractor for the Medicare Molecular Diagnostics program, has expanded its local coverage determination (LCD) for Guardant360, effective February 3, 2020. The move makes the test the first and only liquid biopsy to be covered for use across most solid tumors, the firm said in a statement.

The policy covers Guardant360 for all fee-for-service Medicare patients who could benefit from biomarker information being used to inform cancer treatment decisions, but who have insufficient or unavailable tumor tissue for testing.

"Guardant360 fills the testing gap for patients who are unable to be completely tested using tissue biopsies," Guardant CEO and Cofounder Helmy Eltoukhy said in a statement. "This expanded coverage decision across most advanced solid tumor cancers validates the growing body of evidence showing the clinical utility of using Guardant360 to optimize treatment decisions and demonstrates a commitment to advancing precision oncology."

In a research note SVB Leerink analyst Puneet Souda said that though the Palmetto decision was expected, "we believe the finalization is a positive directional driver for the company, and will lead to an increase in volumes and [average sales price] over time." He added that Guardant officials "highlighted that the pan-cancer LCD should continue to allow for repeat testing, given that any new tumor or indication or different drug allows for repeat testing on" Guardant360.

In afternoon trading on the Nasdaq, shares of Guardant were up 1 percent at $80.36. Shares of the Redwood City, California-based firm are up over 100 percent year-to-date.

Guardant360 uses next-generation sequencing to analyze 73 genes using cell-free tumor DNA from blood samples. Palmetto proposed expanding coverage for the test in March, with a draft LCD. Before that, the test had been covered for patients with advanced non-small cell lung cancer.

The additional indications now covered include melanoma, chordoma, gastrointestinal stromal tumor, and breast, colorectal, endometrial, gastric and gastroesophogeal, ovarian, pancreatic, prostate, and thyroid cancers. Criteria for coverage requires that the patient: be diagnosed with recurrent, relapse, refractory, metastatic, or advanced solid tumor that did not start in the central nervous system; has not yet been tested with Guardant360 for the same cancer; is untreated or not responding to treatment; is a candidate for further treatment; and tissue-based tumor profiling is not feasible.

Souda noted that the LCD "keeps the door open for coverage of other liquid biopsies" for the same indications, but they must display similar performance to Guardant's test.