Guardant Health (GH) FDA Announcement summary

Introduction and purpose

• FDA approved the Shield blood test as a first-line colorectal cancer screening for average-risk individuals aged 45 and older.

• Shield is the first blood test to receive FDA approval as a first-line screening option, aligning with non-invasive screening guidelines and meeting Medicare coverage requirements.

• The approval aims to address low CRC screening rates and marks a significant milestone for liquid biopsy and cancer screening.

Details of approval or decision

• FDA approval follows a strong Advisory Committee recommendation in May 2024.

• Shield's label includes first-line intended use, contraindications, and precautionary language consistent with prior expectations.

• The test meets requirements for Medicare coverage, enabling broad access for eligible patients, with claims eligible from the date of IVD launch.

• Eligible individuals can access Shield by prescription, with Medicare coverage expected.

Impact on industry and stakeholders

• Over 120 million people in the U.S. are eligible for CRC screening, but only 60% are compliant; Shield aims to address this gap by offering a more convenient, non-invasive option.

• The company targets $500 million in revenue by 2028, with a projected annual testing opportunity of 16 million.

• Commercial insurance coverage is anticipated to expand after guideline inclusion by major organizations.

• The test may reach populations less likely to use traditional screening methods.

• Medicare beneficiaries (25 million unscreened) represent a major initial market.