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Natera Cancer Liquid Biopsy Test Coverage to Expand Under New Draft LCD

NEW YORK – Natera said on Thursday that coverage of its Signatera minimal residual disease (MRD) test would expand under a new draft local coverage determination (LCD) issued by Centers for Medicare & Medicaid Services' contractor Palmetto GBA through the Molecular Diagnostics (MolDx) program.

The draft LCD expands coverage for circulating tumor DNA tests that detect MRD in patients with a history of cancer to many cancer types and would include coverage of the Signatera test for immunotherapy response monitoring. Natera pointed out that it specifically mentions Signatera and a pan-cancer validation study that the company recently published in Nature Cancer showing that the test, in conjunction with imaging, identified non-responders to the immune checkpoint inhibitor pembrolizumab (Merck's Keytruda) with a 100 percent positive predictive value.

Natera said the draft LCD also creates a pathway for coverage of Signatera in additional solid tumor types and indications. The firm said the test has already been validated in multiple cancer types for detecting residual disease up to two years earlier than standard diagnostic tools.

Earlier this month, Natera received coverage for Signatera in advanced colorectal cancer under a final LCD released by Palmetto.

"Medicare's proposed coverage offers enormous benefit to the over 200,000 patients being treated with immune checkpoint inhibitors," said Solomon Moshkevich, Natera's general Manager of oncology, in a statement. "We look forward to working with the oncology community to generate further evidence supporting the clinical value of Signatera in both early-stage and advanced-stage cancers."

Cowen research analysts, in a note to investors, pointed out that Natera's laboratory is under the jurisdiction of Noridian, not Palmetto, and would need to wait for Noridian to issue and finalize an LCD before it can bill CMS. "We believe it should be relatively straightforward for a finalized LCD from Noridian given Signatera is already approved for reimbursements in CRC monitoring," they wrote.

"All in all, we believe this is a massive win for Natera's oncology business," said research analyst for investment bank Piper Sandler, in a note to investors.