Question · Q4 2025
Casey Woodring asked about any meaningful contribution from lymphoma or multiple myeloma volumes embedded in the 2026 framework for Signatera and the potential upside from heme MRD volumes. He also inquired about the implications of Signatera's expected Japan approval in 2026 with preliminary coverage for 2027 launch, specifically regarding ASPs, volume opportunity, potential coverage caps, and OpEx impact from sales force/lab capacity build-out.
Answer
Steve Chapman (CEO, Natera) indicated that the contribution from heme MRD is relatively limited in the current model but represents a significant opportunity, especially with the Foresight team's expertise, and could be a major growth driver. For Japan, Steve Chapman noted a reasonable sales team and strong distribution partnership are in place, expecting good ASPs similar to historical precedent and a significant volume/revenue impact in 2027. John Fesko (President and Chief Business Officer, Natera) added that CRC patient numbers in Japan are similar to the U.S., with comparable pricing for molecular genetic products. Steve Chapman clarified that they do not need to wait for the CIRCULATE-Japan readout and are in the final stages with regulatory authorities for a launch later this year.
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