Question · Q4 2025
David Westenberg asked how MolDX will approach histology types for Latitude, how Natera's infrastructure can expedite coverage, and how ADLT will apply to Genome/Latitude (whether it can be 'tucked in' or if it's a completely different process), along with expected reimbursement periods. He also inquired about R&D investments, specifically technology advancement for MRD, and the potential for NCCN-generating studies in 2-3 years for tissue types beyond CRC and muscle-invasive bladder cancer.
Answer
Steve Chapman (CEO, Natera) clarified that Latitude is not planned for ADLT submission as tumor-naive MRD tests are not eligible without FDA approval, and he expects similar pricing to other tumor-naive MRD products. For new Latitude products in other histologies, Natera will generate, publish, and submit validation data, leveraging its 10 years of existing data and biobanks to accelerate the process. Michael Brophy (CFO, Natera) explained that R&D investments are guided by an ROIC framework, targeting incremental volume and pricing growth. He noted that landmark studies drive volume and guideline inclusion, leading to significantly higher ASPs (from current $1200-$1225 to $3000 per covered test), making investments in clinical trials and product evolution crucial for achieving higher realized pricing.
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