Regulatory ChallengesMolDx finalized and maintained a non-coverage decision for CSTL's DecisionDx-Squamous Cell Carcinoma test, leaving Novitas' Oncology LCD finalization as a potential next step in the resolution of coverage questions.
Revenue ImpactPotential near term loss of a growth driver in DDx-SCC, which was about 20% of CSTL's 1Q24 revenue.
Uncertainty In ReimbursementFuture coverage for DDx-SCC remains uncertain as Palmetto continues to noncover the test, and Novitas' decision on oncology LCD is pending.