Guardant Health receives coverage from UnitedHealthcare for Guardant360 CDx blood test as companion diagnostic in advanced lung and breast cancer

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today that UnitedHealthcare (UHC) now covers the Guardant360 CDx liquid biopsy test for patients enrolled in its commercial policies for all FDA-approved companion diagnostic indications. The test is used by oncologists as a companion diagnostic to assess if patients are eligible for a targeted therapy for advanced or metastatic breast or non-small cell lung cancer (NSCLC).

The Guardant360 CDx test was the first blood test approved by the FDA for comprehensive genomic profiling for all solid tumors, and it is now FDA-approved as a companion diagnostic test for four targeted therapies in NSCLC and one in advanced breast cancer. In December 2019, Guardant360 became the first liquid biopsy to be broadly covered by Medicare for use across the vast majority of advanced solid tumors. The new policy coverage by UnitedHealthcare is in addition to existing coverage of the Guardant360 CDx test under UHC Medicare Advantage policies for comprehensive genomic profiling of all solid tumors.

“We are pleased that UnitedHealthcare has taken this important step to make comprehensive genomic profiling more accessible to patients with advanced lung and breast cancer,” said Helmy Eltoukhy, Guardant Health co-CEO. “The biomarker identification available through the Guardant360 CDx blood test can enable oncologists to quickly identify patients who may benefit from a therapy targeted to their specific type of mutation to help improve their outcomes. We believe this important decision will help expand patient access to genomic profiling across additional tumor types and healthcare plans in the coming years.”

This year, an estimated 236,740 adults in the U.S. will be diagnosed with lung cancer, which is the leading cause of cancer death worldwide.¹ Non-small cell lung cancer, the most common type in the U.S., represents about 82% of all lung cancer.² Worldwide, female breast cancer has now surpassed lung cancer as the most commonly diagnosed cancer and is the fifth leading cause of death. This year, an estimated 287,850 women in the United States will be diagnosed with invasive breast cancer, and 51,400 women will be diagnosed with non-invasive (in situ) breast cancer.³ Due to the expanded coverage decision, the Guardant360 CDx test will now be covered for comprehensive genomic profiling for all lives covered by UnitedHealthcare, the largest U.S. national health insurer in commercial and Medicare Advantage markets.