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Guardant Health Secures New Commercial Payor Coverage for Liquid Biopsy Cancer Profiling Test

NEW YORK – Guardant Health said Wednesday that it has received new commercial health plan coverage for its Guardant360/Guardant 360 CDx liquid biopsy cancer profiling test from Anthem Blue Cross and Blue Shield, Aetna, and Humana.

A liquid biopsy assay for comprehensive genomic profiling, the Guardant360 test analyzes circulating tumor DNA (ctDNA) in blood to detect actionable cancer biomarkers that may help inform a patient's therapy selection.

Guardant said that with the new coverage, its flagship test is now covered for this profiling indication by all major US commercial health insurers. The firm estimated that total health insurer coverage for the Guardant360 test now represents over 300 million lives in the US.

"The Guardant360 blood test can help oncologists quickly identify the specific mutations driving cancer in order to select the most appropriate therapy. We believe this recognition of the clinical value of our test will result in improved outcomes for more patients with cancer," Guardant co-CEO Helmy Eltoukhy said in a statement.

The new coverage wins follow a decision by UnitedHealthcare earlier this year to cover the US Food and Drug Administration-approved companion diagnostic version of the test, Guardant360 CDx, in advanced lung and breast cancer.

Under Anthem Blue Cross and Blue Shield, Guardant360 is now covered for genomic profiling of any solid tumor to identify actionable biomarkers to inform therapy selection. The payor operates in 14 states and provides 32 million individuals with access to more than 1.7 million doctors and hospitals nationwide.

According to Guardant, Aetna additionally confirmed commercial coverage of the Guardant360 CDx test to identify ESR1 gene mutations in individuals with advanced breast cancer being considered for treatment with Menarini's Orserdu (elacestrant).

Humana also granted coverage for the test as a companion diagnostic to identify patients with certain types of breast cancer who are eligible for treatment with Orserdu.