Personalis, Inc. released a new study in the journal Clinical Cancer Research that evaluates its NeXT Personal® assay in 202 stage‑IV solid‑tumor patients treated with immune checkpoint inhibitors and other immunotherapies. The paper, titled “Broad Utility of Ultrasensitive Analysis of ctDNA Dynamics across Solid Tumors Treated with Immunotherapy,” reports that the assay can detect circulating tumor DNA at a sensitivity of one fragment per million and tracks up to approximately 1,800 tumor‑specific variants across 24 cancer types.
The study’s findings suggest that the NeXT Personal® test can provide an early molecular indicator of treatment response or resistance in a wide spectrum of solid tumors. By demonstrating broad applicability, the data strengthen Personalis’ evidence portfolio for Medicare reimbursement and support the company’s strategy of expanding the test’s market beyond the breast, lung, and colorectal indications for which coverage is currently being pursued. Medicare coverage for breast‑cancer recurrence monitoring became effective retroactively on October 7, 2025, underscoring the test’s clinical relevance.
In its most recent quarter, Personalis reported revenue of $14.5 million for Q3 2025, a 44% decline from $25.7 million in Q3 2024. Revenue from pharma tests and services and other customers accounted for $12–$17 million, while population sequencing and enterprise sales contributed about $3.7 million. Gross margin fell to 27.6% in Q2 2025 from 35.6% in Q2 2024, reflecting lower volume, a shift toward lower‑margin segments, and higher unreimbursed clinical test costs. Despite the revenue decline, the company posted earnings per share of –$0.24, beating analyst consensus of –$0.28, largely due to disciplined cost management and the absence of one‑time charges.
CEO Chris Hall highlighted the Medicare coverage as a validation of the technology, stating that it “confirms the clinical value of our assay and empowers clinicians to make data‑driven decisions.” Chief Medical Officer Richard Chen expressed enthusiasm about the study’s demonstration of the assay’s ability to monitor therapy in late‑stage metastatic patients, noting that the results “open new avenues for clinical adoption and payer acceptance.” Management also acknowledged the revenue headwinds stemming from reduced demand from biopharma customers and the need to invest in growth initiatives.
Looking ahead, Personalis expects full‑year 2025 gross margin to be in the 22%–24% range, down from 32% in 2024, as the company continues to invest in expanding clinical use of NeXT Personal ahead of reimbursement. The company’s guidance for the remainder of the year remains unchanged, but management signals caution regarding near‑term demand volatility while emphasizing confidence in long‑term growth driven by the study’s findings and Medicare coverage.
The publication of this study, coupled with the recent Medicare coverage, positions Personalis to accelerate broader adoption of its NeXT Personal® test and potentially expand reimbursement beyond current indications. However, the company’s recent revenue decline and margin compression highlight ongoing challenges that will require continued cost discipline and strategic investment to sustain growth.
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