Dive Brief:
- Guardant Health said Wednesday its Shield test for colorectal cancer is now covered by UnitedHealth, the first major private U.S. health insurer to reimburse for the screening.
- The decision by UnitedHealth, the largest private U.S. health insurer, expands access to the screening to about 100 million Americans, the company said.
- Canaccord Genuity analyst Kyle Mikson, in a note to clients, called the coverage decision a “watershed moment” for liquid biopsy-based cancer screening and for the category of blood-based cancer testing.
Dive Insight:
Shield is the first blood test approved by the Food and Drug Administration for primary colorectal cancer screening in average-risk adults 45 and older.
The Shield test can be completed with a blood draw during a routine doctor’s visit, offering an alternative to stool-based tests. The methylation partitioning cell-free DNA test detects alterations associated with colorectal cancer in the blood.
The screening is not intended for people at high risk for colorectal cancer. Patients with a positive Shield result are referred for colonoscopy evaluation, which remains the gold standard for colorectal cancer screening.
UnitedHealth’s decision to cover Shield is a critical milestone in Guardant’s commercial expansion, co-CEO AmirAli Talasaz said in a statement, making the test more accessible at a time when rates of colorectal cancer in younger people are on the rise.
Canaccord Genuity’s Mikson said receiving coverage from a major commercial payer before the screening has been included in the U.S. Preventive Services Task Force guidelines suggests the test covers a critical unmet need for patients and demonstrates increasing acceptance of liquid biopsy-based testing.
“This is the first coverage from a major commercial insurer for a blood-based cancer screening test, which we believe suggests increasing support for liquid biopsy testing,” Mikson wrote.
