Alex Vukasin

Alex Vukasin asked about the recent NCCN update for DecisionDx-Melanoma, seeking elaboration on takeaways, confidence in guideline inclusion, and its importance, especially given the test's unique 31-GEP nature and demonstrated patient survival benefits.

Answer

Derek Maetzold, Founder, President, and CEO of Castle Biosciences, explained that the NCCN update maintained the 5% threshold for sentinel lymph node biopsy consideration. He highlighted DecisionDx-Melanoma's consistent ability to show low-risk results comfortably below 5%, enabling patients to potentially avoid unnecessary surgery. He noted that the Merlin test failed to achieve this threshold and that NCCN's review cited only 11 of Castle's 58 peer-reviewed publications, omitting significant data like the SEER publication. Alex Vukasin also inquired about the timeline for FDA submission and approval for DecisionDx-Melanoma, and its anticipated impact on payer discussions, adoption rates, and test volume growth. Derek Maetzold stated that the company is preparing a de novo 510(k) submission, with potential clearance by late 2026 or early 2027. He emphasized that the primary driver for FDA clearance is to leverage newer state biomarker laws to reduce non-payments from commercial insurance carriers and improve the overall commercial ASP, rather than expecting a substantial change in volume uptake from clinicians.

Alex Vukasin asked about the recent NCCN update for DecisionDx-Melanoma, seeking elaboration on takeaways, confidence in guideline inclusion, and its importance, especially given the test's unique 31-GEP nature and demonstrated patient survival benefits.

Answer

Derek Maetzold, Founder, President, and CEO of Castle Biosciences, explained that the NCCN update maintained the 5% threshold for sentinel lymph node biopsy consideration. He highlighted DecisionDx-Melanoma's consistent ability to show low-risk results comfortably below 5%, enabling patients to potentially avoid unnecessary surgery. He noted that the Merlin test failed to achieve this threshold and that NCCN's review cited only 11 of Castle's 58 peer-reviewed publications, omitting significant data like the SEER publication. Alex Vukasin also inquired about the timeline for FDA submission and approval for DecisionDx-Melanoma, and its anticipated impact on payer discussions, adoption rates, and test volume growth. Derek Maetzold stated that the company is preparing a de novo 510(k) submission, with potential clearance by late 2026 or early 2027. He emphasized that the primary driver for FDA clearance is to leverage newer state biomarker laws to reduce non-payments from commercial insurance carriers and improve the overall commercial ASP, rather than expecting a substantial change in volume uptake from clinicians.

Alex Vukasin of Canaccord Genuity inquired about GRAIL's Q2 cash burn and the key dynamics expected to impact the burn rate in the second half of 2025.

Answer

CFO Aaron Freidin noted a first-half burn of approximately $160 million and projected a decrease in the second half, driven by higher volumes, increased revenue, and greater efficiency from the new automated platform. CEO Bob Ragusa added that the company's restructuring provided flexibility, leading to an improved full-year cash burn guidance of no more than $310 million.

Alex Vukasin, on behalf of Kyle Mixon from Canaccord Genuity, asked about the long-term potential volume mix between primary care physicians and pulmonologists. He also inquired about the expected timing and impact of the HEDIS quality measures for lung cancer screening.

Answer

Scott Hutton, President, CEO & Director, responded that it is too early to forecast a specific long-term volume mix, as the strategy is to follow pulmonologist referrals. Regarding HEDIS, Hutton stated the measures have been put on hold for the year due to cited complexities. He noted this delays a potential tailwind but does not impact the company's 2025 or 2026 forecasts.