Leerink sees preliminary CLFS determinations as a negative for Quanterix

Leerink analyst Puneet Souda notes that the preliminary Clinical Lab Fee Schedule, or CLFS, determinations for new codes were published with worse than expected decisions for neuro diagnostics. While the advisory panel, or CDLT, voted to crosswalk to $130 for tests like blood-based pTau-217, CMS disagreed and recommended a crosswalk to just $17. The firm views this as a negative update for Quanterix, though Leerink believes most of the Alzheimer’s Dx expectations are already out of the stock. The firm remains positive on Outperform-rated Quanterix given the progress its base business has shown even in a constrained biopharma and biotech end-market, but believes investors will be looking for a clear line of sight to FDA approval and a head start in the market vs. competitors to gain more comfort in Quanterix’s long term position in AD Dx.