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Natera's Signatera Gains First Commercial Payor Coverage in California, Louisiana

NEW YORK – Natera announced Thursday that Blue Shield of California, as well as Blue Cross and Blue Shield (BCBS) of Louisiana, is covering Signatera for multiple cancer indications.

They are the first commercial payor coverage for the test, Austin, Texas-based Natera said.

On March 1, Blue Shield of California began covering Signatera for policyholders diagnosed with any solid stage I-IV tumors. The insurer describes testing via Signatera as medically necessary in these cases to inform decisions on adjuvant or targeted therapy, and/or to monitor for relapse or progression, including but not limited to the use of immunotherapy.

BCBS of Louisiana began providing coverage effective Jan. 1 for policyholders diagnosed with colorectal and muscle invasive bladder cancer, and for pan-cancer immunotherapy monitoring.

These decisions follow the decision in mid-February by the Centers for Medicare and Medicaid Services to grant Signatera Medicare coverage for adjuvant and recurrence monitoring in cases of stage IIb or higher breast cancer.

Today's announcement follows comments made during Natera's fourth quarter earnings conference call this week that it is currently focused on expanding private coverage.

Public and private payor decisions come on the heels of Natera's recently published CIRCULATE-Japan study, one of the largest studies to date of minimal residual disease testing in resectable colorectal cancer.

While Natera expects the results of that study to further drive clinician adoption of Signatera, the firm noted in its Q4 investor call that the timing of its publication makes it uncertain whether the National Comprehensive Cancer Network committee will include that evidence in its consideration for guideline inclusion this round.

"Following the recent breast cancer coverage decision by Medicare, achieving our first commercial coverage policies for Signatera — including one that encompasses pan-cancer coverage — is another major milestone for Natera and the patients who will now have enhanced access to tumor-informed ctDNA testing," John Fesko, Natera's chief business officer, said in a statement.