Personalis’ NeXT Personal® Detects 100% of Colorectal Cancer Relapses Ahead of Imaging in VICTORI Cancer Study

• 100% of resectable Stage I-IV colorectal cancer relapses were detected ahead of imaging, with 87% of those relapses having been detected in the first eight weeks following surgery

FREMONT, Calif.--(BUSINESS WIRE)-- Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced new interim analysis results of the VICTORI study showing strong performance of its ultra-sensitive NeXT Personal assay in detecting early signs of residual or recurrent colorectal cancer (CRC).

The study, led by Dr. Jonathan Loree’s team at BC Cancer in Vancouver, Canada, utilized NeXT Personal to look for small traces of circulating tumor DNA (ctDNA) in blood samples from a cohort of 71 patients with resectable Stage I-IV CRC. The data was presented at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, Illinois by Emma Titmuss at BC Cancer, in an oral presentation titled Detection of post-surgical minimal residual disease (MRD) in colorectal cancer; preliminary results from the VICTORI study.

“After surgery, ctDNA-based liquid biopsies may help identify patients who would benefit most from additional treatment,” said Jonathan Loree, MD, MS, a medical oncologist at BC Cancer and the senior investigator of the study. “Alternatively, this may help patients with good prognosis avoid toxicities from unnecessary chemotherapy. By monitoring patients for recurrences, liquid biopsies can continue to support clinical care and allow more patients to undergo second curative intent surgeries to remove early recurrences.”

Key findings presented from the interim analysis for VICTORI:

• 100% of patients who have recurred were detected as ctDNA positive by NeXT Personal prior to detection on imaging.
• 100% of patients who have been ctDNA negative throughout the study remain disease-free.
• 87% of clinical recurrences were detectable within the early “landmark window” 2 to 8 weeks after surgery, with 85% detectable by 4 weeks.
• 64% of detections within the landmark window were in the ultrasensitive range (under 100 ppm).
• 100% of distant metastatic recurrences were detected prior to imaging, including lung metastasis, an area which has traditionally been more challenging to detect by ctDNA testing.
• 70% of the first ctDNA detections were in the ultrasensitive range, with a median of 24.4PPM and as low as 2.45 PPM.

Median patient follow-up at the time of the interim analysis was 15.75 months, with the patients continuing to be followed clinically.

“The initial results from our study show the importance of using a highly sensitive MRD assay like NeXT Personal in colorectal cancer,” said Dr. Loree.

“We are encouraged by the preliminary results from the VICTORI study, which show the ability of our ultrasensitive ctDNA assay NeXT Personal to detect residual and recurrent colorectal cancer at high rates in the early landmark window after surgery,” said Dr. Richard Chen, Chief Medical Officer and Executive Vice President, R&D at Personalis. “We continue to expand this prospective study as we strive towards helping patients with colorectal cancer detect and treat recurrence earlier.”

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 a patient’s response to therapy, 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. 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 AACR.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250428881134/en/

Investors:

Caroline Corner

investors@personalis.com

415-202-5678

Media Contact

pr@personalis.com

Source: Personalis, Inc.