Minimal Residual Disease (MRD) Testing

The draft LCD would cover the Signatera minimal residual disease test for several solid tumor types and indications, including immunotherapy response monitoring.

The Signatera test is optimized for molecular residual disease (MRD) assessment and for monitoring treatment in cancer patients.

The sequencing-based test for minimal residual disease can be use with blood and bone marrow samples in patients with chronic lymphocytic leukemia.

ArcherDX said the firms aim to apply minimal residual disease monitoring in clinical-trial protocols and for future therapy optimization.

ArcherDx will develop sequencing-based circulating tumor DNA assays for use in AstraZeneca's recently launched Phase III MERMAID-1 trial of durvalumab (Imfinzi).

Natera's Signatera test will be used to select and monitor eligible patients with KRAS-mutant tumors who have molecular residual disease after surgery.

Genentech will use Adaptive's ClonoSeq assay for MRD testing in a CLL study. Adaptive will receive upfront and sample testing payments of undisclosed amounts.