By: Jonah Feldman, Jason M. Broderick
FDA breakthrough device designation was supported by MERLIN_001, positioning Merlin CP-GEP for expedited regulatory interaction as a diagnostic adjunct in early-stage melanoma management decisions. NCCN endorses selective CP-GEP use for SLNB decision-making in T1b/T2a melanoma when clinicians would forgo SLNB below a 10% nodal-risk threshold.




