Personalis, Inc. announced that the PREDICT‑DNA study, a prospective trial of its NeXT Personal® platform, has been published in the Journal of Clinical Oncology. The study followed 227 patients with triple‑negative and HER2‑positive breast cancer across more than 24 U.S. cancer centers and demonstrated that the platform’s ultrasensitive circulating tumor DNA assay detected minimal residual disease with higher accuracy than current standard approaches, providing earlier prediction of recurrence.
The trial showed that detectable ctDNA after neoadjuvant therapy was associated with a 4‑ to 9‑fold higher likelihood of relapse, and ctDNA status was a more significant independent prognostic signal than nodal status, tumor grade, or pathologic complete response in multivariate analyses. Fifty‑five percent of ctDNA detections occurred at levels below 100 parts per million, a range that could be missed by less sensitive tests. These findings confirm the platform’s ability to identify residual disease months before imaging can detect recurrence.
The publication is a key milestone for Personalis because it supplies the clinical evidence needed to support Medicare coverage for its NeXT Personal® MRD test. Medicare coverage for breast cancer surveillance was announced on November 10, 2025, and for lung cancer surveillance on February 10, 2026. Coverage for breast cancer applies to Medicare beneficiaries with stage II and III disease for up to six years. The study’s data strengthen the company’s reimbursement dossier and could accelerate access to its flagship diagnostic in the $20+ billion MRD market.
The results also reinforce Personalis’ competitive advantage over incumbents such as Guardant Health and Natera, which already have Medicare coverage for their MRD tests. By demonstrating superior detection of residual disease, Personalis positions its NeXT Personal® platform as the most sensitive option available, potentially capturing greater market share as payers and clinicians seek the most accurate tools for post‑treatment monitoring.
Financially, Personalis reported Q4 2025 revenue of $17.3 million, a 3% year‑over‑year increase, and a gross margin of 11% for the quarter versus 22.7% for the full year. The company guided 2026 revenue to $78–$80 million, below analyst expectations of approximately $85.2 million, which contributed to investor concern. EPS for Q4 2025 was –$0.26 versus an estimate of –$0.30, a beat of $0.04, largely driven by strict cost controls that maintained margins despite a modest revenue decline.
Richard Chen, MD, Chief Medical Officer, said, "The publication of this data is important as we look to expand reimbursement and improve the tools used in neoadjuvant monitoring.” Chris Hall, CEO, added, "Securing Medicare coverage for lung cancer surveillance is a big step forward on two fronts: it broadens patient access to NeXT Personal for one of the most common cancers in the U.S., and it is a catalyst for our continuing growth.”
Investor reaction to the earnings release on February 26, 2026 was positive, driven by the EPS beat, while the guidance issued on March 6, 2026 was met with concern because it fell short of analyst expectations, indicating a slower near‑term revenue inflection than anticipated despite the recent Medicare coverage wins.
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