Personalis (NASDAQ:PSNL) executives on the company’s fourth quarter 2025 earnings call highlighted accelerating clinical adoption of its ultra-sensitive NeXT Personal minimal residual disease (MRD) test, recent Medicare coverage wins in breast and lung cancer surveillance, and plans to scale test volumes in 2026 while continuing to invest heavily in commercialization and evidence generation.
Clinical testing volumes surged as company eyes 2026 scale-up
CEO Chris Hall said 2025 “validated” Personalis’ “Win-in-MRD” strategy and framed 2026 as a year to scale. In the fourth quarter, Personalis delivered 6,183 clinical tests, up 41% sequentially and 329% year-over-year. For the full year, the company delivered more than 16,000 clinical tests, up 394% compared with 2024.
For 2026, management set initial annual clinical volume guidance of 43,000 to 45,000 tests, which it said would represent about 170% year-over-year growth. The company noted it had more than 900 oncologists ordering the test in the most recent quarter and described strong retention among adopters.
Medicare coverage wins and reimbursement strategy
Hall said the “headline” achievements in 2025 included “two Medicare coverage decisions.” Personalis reported it received Medicare coverage for breast cancer surveillance in the fourth quarter with what it characterized as favorable pricing, and more recently received coverage for lung cancer surveillance. Hall emphasized that both reimbursement frameworks cover ongoing surveillance, allowing tests to be used at multiple time points over a patient’s journey.
The company also has an additional dossier under review with MolDx for use of NeXT Personal to monitor immunotherapy response in metastatic cancer patients. Management said timing remains subject to MolDx review but expressed confidence in its data, while also noting that 2026 guidance does not assume immunotherapy coverage.
During Q&A, Hall said Medicare coverage helps in physician conversations by adding legitimacy, citing the rigor of the MolDx review process.
Evidence generation: published studies and pipeline of trials
Executives pointed to multiple publications and ongoing studies supporting NeXT Personal’s performance and intended clinical utility. Hall cited landmark studies including:
- TRACERx lung cancer study (over 400 patients), which he said showed strong sensitivity and specificity from diagnosis through surveillance, including in lung adenocarcinoma.
- Royal Marsden breast cancer study, which he said showed strong sensitivity and specificity across major breast cancer subtypes with a median lead time of more than 15 months ahead of imaging.
- VHIO study across 24 cancer types, which he said showed advanced cancer immunotherapy patients with durable molecular clearance had 100% overall survival.
Hall also referenced the PAM Cancer UCSD I-PREDICT study published in npj Precision Oncology, which he said showed NeXT Personal identified molecular progression a median of 161 days before imaging in late-stage cancer patients receiving immunotherapy. He added that Yale University is leading a breast cancer case study and that the prospective B-STRONGER-I trial in triple-negative breast cancer has enrolled more than 200 patients.
Management said Personalis is involved in more than 35 additional studies and is targeting additional coverage submissions in 2026 for neoadjuvant breast cancer and colorectal cancer, though it did not provide specific timelines because submissions depend on manuscript submission and acceptance.
Biopharma MRD: growth amid a stabilizing spending environment
Personalis reiterated its position as a partner to biopharma companies in clinical trials and drug development, with Hall saying its MRD offering can help partners “fail sooner” in early trials, succeed faster, and enroll the right patients.
Hall said MRD biopharma revenue grew nearly 240% over 2024. CFO/COO Aaron Tachibana similarly reported 239% growth in biopharma MRD revenue despite headwinds in the broader business from legacy work. In Q&A, Hall said the biopharma sector appeared to be stabilizing, adding that the company was not seeing pushouts or major cancellations, but also was not seeing a major rebound in large translational research spending.
For 2026, the company guided to biopharma revenue (tests and services plus other customers) of $55 million to $56 million, with MRD revenue within that category expected to be $20 million to $21 million. Management also discussed the business shifting toward more prospective work, where revenue is recognized over several years, compared with retrospective analyses recognized in larger batches.
Financial results, margin dynamics, and 2026 outlook
For the fourth quarter, Personalis reported total revenue of $17.3 million, up 3% from $16.8 million in the prior-year quarter. Full-year 2025 revenue was $69.6 million. Management attributed the year-over-year shift in the top line to a planned transition away from lower-value work and the impact of legacy program changes, including a $19.5 million decline in revenue from Natera and a $10 million decline tied to the conclusion of enrollment in Moderna’s melanoma trial.
By segment, the company reported:
- Biopharma revenue: $10.9 million in Q4 (vs. $12.2 million a year earlier) and $49 million in 2025 (vs. $51 million in 2024), with declines attributed primarily to lower Moderna volume.
- Clinical revenue: $0.9 million in Q4 and $2.0 million for 2025, up from $0.2 million in Q4 2024 and $0.8 million for 2024, with Q4 including initial breast cancer surveillance revenue covered by Medicare.
Gross margin was 11% in the fourth quarter and 22.7% for the full year. Tachibana said the margin compression is “intentional but temporary,” driven by rapid growth in clinical volume ahead of reimbursement, noting unreimbursed costs diluted Q4 margins by roughly 1,900 basis points. He said the lowest margin point is expected in the first quarter of 2026, until additional reimbursement coverage (which management expects could include immunotherapy) begins to convert to revenue.
Operating expenses were $27.2 million in Q4 and $103.8 million for 2025, reflecting increased commercial spending to drive volume and R&D to support reimbursement and technology development. Net loss was $23.8 million in Q4 and $81.3 million for the full year, unchanged from 2024.
Personalis ended the year with $240 million in cash and short-term investments and no debt other than small equipment loans. The company said it used approximately $74 million of cash in 2025, just below its guidance.
For 2026, Personalis guided to:
- Total revenue: $78 million to $80 million
- Clinical revenue: $10 million to $11 million (from Medicare-covered breast and lung surveillance)
- Population sequencing plus enterprise: approximately $13 million
- Gross margin: 15% to 20% (with Q1 potentially the low point)
- Net loss: approximately $105 million
- Cash usage: approximately $100 million
Tachibana said the company is prioritizing market-share capture and described the current plan to increase its dedicated field team, noting Personalis ended 2025 with 10 reps and intends to roughly double that. Management also provided an estimate of the anticipated 2026 test mix by indication, stating that roughly 20% of volume is expected to come from breast cancer, 15% to 20% from lung, 20% to 25% from immunotherapy, around 20% from colorectal cancer, and the remainder from other indications, while acknowledging that breast and lung are the only covered indications at this time.
Executives also discussed a new NeXT Personal “Real-Time Variant Tracker” opt-in report, introduced via an early access program, which is intended to help detect targetable and resistance mutations during MRD surveillance. Management said it was preparing for the early access program and described early feedback from physicians as positive.
About Personalis (NASDAQ:PSNL)
Personalis, Inc (NASDAQ: PSNL) is a clinical‐stage genomics company that develops and markets advanced next‐generation sequencing (NGS) services and assays designed to accelerate precision medicine. The Company’s core offering is the ImmunoID NeXT™ Platform, which combines comprehensive tumor profiling—including whole exome, transcriptome, and T‐cell receptor sequencing—with proprietary bioinformatics to identify biomarkers and guide immuno‐oncology research. Personalis serves biopharmaceutical companies, academic institutions, and clinical research organizations seeking in‐depth insights into cancer, autoimmune diseases and other complex conditions.
In addition to its flagship ImmunoID NeXT™ Platform, Personalis offers a suite of customizable sequencing assays for biomarker discovery, clinical trial support and companion diagnostic development.
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