FDA Approves Expanded Liquid Biopsy Panel

Updated liquid biopsy combines genomic and epigenomic profiling for companion diagnostic use across multiple tumor types.

Category	Detail
Condition	Advanced Cancer
Key Mechanisms	Comprehensive molecular profiling through genomic and epigenomic analysis from a blood sample.
Target Population	Patients with advanced cancer, including those with non–small cell lung cancer, colorectal cancer, and advanced breast cancer with ESR1 mutations.
Care Setting	Applicable across multiple stages of cancer care, including treatment selection, recurrence monitoring, and cancer screening.

Largest FDA-approved liquid biopsy panel with a genomic footprint 100 times broader than previous versions.
Combines genomic and epigenomic profiling to enhance circulating tumor DNA detection sensitivity.
Identifies clinically actionable findings not detectable through genomic analysis alone.
Results available within 7 days and usable regardless of tissue availability.
Covered by Medicare and commercial insurers for over 300 million lives.

Support treatment selection for advanced cancer therapies, particularly in non–small cell lung cancer and colorectal cancer.

Patients with advanced cancer, particularly those with specific mutations.

Facilitates targeted therapy selection and improves treatment outcomes.

Incorporate liquid biopsy results into clinical decision-making.
Use the assay in conjunction with other diagnostic tools for comprehensive care.

Clinical Scorecard: FDA Approves Expanded Liquid Biopsy Panel