Personalis’ NeXT Personal® Predicts Cervical Cancer Recurrence Risk in New CALLA Phase 3 Study Analysis Presented at ASCO

FREMONT, Calif.--(BUSINESS WIRE)-- Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, announced the presentation of new results from the CALLA phase 3 study showing for the first time its ultrasensitive NeXT Personal circulating tumor DNA (ctDNA) blood test detected cervical cancer progression, up to 16 months ahead of imaging. The results demonstrate the potential of NeXT Personal to enable earlier detection in a cancer with high recurrence rates.

The results were presented yesterday by Jyoti Mayadev, MD, from the University of California San Diego, at the American Society for Clinical Oncology (ASCO) 2025 Annual Meeting in Chicago in an oral presentation titled “Ultrasensitive detection and tracking of circulating tumor DNA (ctDNA) and association with relapse and survival in locally advanced cervical cancer (LACC): Phase 3 CALLA trial analyses.” The results from this study were also simultaneously published in the journal Annals of Oncology.

Samples were analyzed from patients with cervical cancer who had enrolled in the original CALLA clinical trial. In this new study analysis, NeXT Personal was used to look for small traces of ctDNA in blood samples from a cohort of 186 patients with locally advanced cervical cancer. Dr. Mayadev’s team found that overall ctDNA levels after chemoradiotherapy (CRT) treatment were strongly predictive of risk of cervical cancer progression.

“Despite standard chemoradiotherapy, up to half of patients with locally advanced cervical cancer relapse, underscoring the urgent need for better prognostic tools. In the CALLA phase 3 study, ultrasensitive, tumor-informed ctDNA analysis emerged as a powerful predictor of progression and survival—detecting relapse up to ~16 months before imaging. These findings highlight ctDNA’s potential to guide treatment decisions and personalize care in high-risk cervical cancer,” said Dr. Mayadev.

Key findings presented:

• Detection of ctDNA following CRT was independently prognostic of patient outcomes.
• Risk of progression and death were at least 95% lower for patients where ctDNA was not detected ~3 months after completing CRT.
• Detection of ctDNA after CRT was associated with high subsequent risk of disease progression, and was detected a median of ~5 months and up to ~16 months earlier than by imaging scans.
• High ctDNA levels (≥ median) at baseline was associated with higher risk of progression and death.

“We are excited to see the results presented for NeXT Personal in this large phase 3 study in cervical cancer,” said Richard Chen, MD, Chief Medical Officer and Executive Vice President, R&D at Personalis. “Cervical cancer is the fourth most common cancer for women globally, resulting in hundreds of thousands of deaths each year. The new results show the strong potential for an ultrasensitive MRD test like NeXT Personal to inform treatment for cervical cancer patients.”

About Personalis, Inc.

At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care throughout the patient journey. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California. To learn more, visit www.personalis.com and connect with us on LinkedIn and X (Twitter).

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release that are not historical are “forward-looking statements” within the meaning of U.S. securities laws, including statements relating to the attributes, advantages, sensitivity, clinical relevance or importance of the NeXT Personal test. Such forward-looking statements involve known and unknown risks and uncertainties and other factors that may cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements, including the risks, uncertainties and other factors that relate to the ability of NeXT Personal to detect small traces of ctDNA, detect residual or recurrent cancer early (including detection earlier than standard of care imaging), monitor or predict a patient’s response to therapy or risk of cancer recurrence, accurately predict clinical outcomes for cancer patients, or impact cancer care or management (including for escalation or de-escalation of treatment), or to the clinical adoption or use of, or the ability of Personalis to obtain Medicare coverage or reimbursement for, the NeXT Personal test, or to the sufficiency of the publication and study results described in this press release to support such adoption, use, coverage or reimbursement. These and other potential risks and uncertainties that could cause actual results to differ materially from the results predicted in these forward-looking statements are described under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Personalis’ Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission (SEC) on February 27, 2025, and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 6, 2025. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. Personalis undertakes no duty to update this information unless required by law.

Not affiliated with or endorsed by ASCO.

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Source: Personalis, Inc.