Financial StabilityAdditional financing will likely be required to build out commercial infrastructure for successful market penetration.
Operational RisksA massive RIF cuts costs but also commercial heft, with potential margin impacting ASP pressures and a multi-year timeline to a potential FDA and CMS regulatory and reimbursement pathway raising concern.
Regulatory ChallengesBroad reimbursement and adoption hinge on the NHS-Galleri readout and subsequent FDA approval, which are several years away.