Tom Stevens

Tom Stevens asked about expectations for adjuvant reimbursement in breast and lung cancer over the next couple of years, and any potential pushback from MolDx.

Answer

Rich Chen, Chief Medical Officer and EVP R&D, confirmed that pursuing adjuvant breast and lung reimbursement is a key focus. Tom Stevens also inquired about the neoadjuvant opportunity, including how pharma is applying these tests in trials today and any initial market sizing. Rich Chen highlighted intense biopharma interest in using highly sensitive assays like NeXT Personal in the neoadjuvant setting to get early reads on drug efficacy, citing strong data presented last year. He did not provide specific market sizing but noted that neoadjuvant use is a relatively smaller fraction of the overall MRD patient journey compared to long-term surveillance.

Tom Stevens asked about expectations for adjuvant reimbursement in breast and lung cancer over the next couple of years, including any pushback from MolDX. He also inquired about the neoadjuvant opportunity, specifically where pharma is applying it in trials today and potential initial market sizing for this segment.

Answer

Rich Chen, Chief Medical Officer and EVP of R&D, confirmed that adjuvant breast and lung reimbursement is a focus and will be pursued. He noted significant biopharma interest in neoadjuvant settings, as highly sensitive assays like NeXT Personal can provide early reads on drug efficacy. Chen highlighted Personalis's strong data in neoadjuvant breast cancer, showing performance comparable to or better than pCR. He added that while neoadjuvant is a smaller fraction of the overall MRD patient journey, surveillance over many years in breast and early-stage lung cancer is a larger opportunity, which is why they focused there first.

Tom Stevens asked about the long-term strategy for the reusable flow cell, questioning if the focus has shifted to prioritizing gross margin over higher throughput. He also asked how recent progress on unit costs impacts the long-term gross margin outlook.

Answer

President and CEO Christian Henry affirmed the company's strategy is to pursue both higher throughput and lower costs to compete with short-read sequencing on price and scale. Regarding margins, he said that while long-term guidance is unchanged, the objective is a dramatic increase driven by innovations like the reusable cell and ongoing cost reductions, with a near-term goal of exiting 2025 with gross margin above 40%.