Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced the publication of the PREDICT-DNA study in the Journal of Clinical Oncology. The article, “The Pathologic Response Evaluation and Detection In Circulating Tumor-DNA (PREDICT-DNA) study: Ultrasensitive ctDNA Assessment of Breast Cancer Minimal Residual Disease,” showed that ultrasensitive molecular residual disease (MRD) testing with Personalis’ NeXT Personal can perform better than current standard approaches in predicting patient outcomes following neoadjuvant therapy (NAT).
The prospective study followed 227 patients with Triple-Negative (TNBC) and HER2+ breast cancer across more than 24 leading US cancer centers. The results demonstrate the ability of Personalis’ NeXT Personal to provide a more precise risk-stratification for patients who have received NAT.
A key finding of the study was the necessity of the ultrasensitive range for accurately tracking patient response to neoadjuvant therapy. Of note, 55% of all ctDNA detections following NAT occurred at levels below 100 parts per million, detections that could be missed with less sensitive tests developed outside of Personalis’ ultrasensitive approach.
“Many breast cancer patients receive neoadjuvant therapy as standard of care, prior to surgery. The results of this study suggest that an ultrasensitive ctDNA assay like NeXT Personal could help patients better understand their response to neoadjuvant therapy, with the potential to help inform the need for additional therapy,” said Richard Chen, MD, Chief Medical Officer and Executive Vice President, R&D at Personalis. “The publication of this data is important as we look to expand reimbursement and improve the tools used in neoadjuvant monitoring.”
Key study highlights include:
- High Prognostic Power: Detectable ctDNA post-NAT was associated with a 4 to 9 times higher likelihood of relapse.
- Superior to Traditional Metrics: In multivariate analyses, ctDNA status was the most significant independent prognostic signal, performing better than nodal status, tumor grade, and pathologic complete response (pCR) status. In addition, ctDNA detection post-NAT was a stronger predictor of recurrence than pCR status.
- Identification of Low Risk: Patients who were ctDNA-negative post-NAT showed excellent outcomes, regardless of pCR status.
- Post-Surgical Relapse Prediction: Patients with detectable ctDNA up to 12 months post-surgery were more than 100 times more likely to experience disease recurrence.
“We partnered with Personalis because their technology offers a level of sensitivity down to 1 to 3 parts per million that allows for a higher cancer detection rate,” said Dr. Ben Park, MD, PhD, Director of the Vanderbilt-Ingram Cancer Center. “The PREDICT-DNA results show that if a patient clears their ctDNA, their outcomes are excellent even if residual disease is found at surgery. Conversely, detectable ctDNA signals a very high risk. These insights allow us to more precisely risk-stratify breast cancer patients in future trials and clinical practice.”
The findings reinforce the NeXT Personal test’s ability to detect ctDNA at ultrasensitive levels, providing a window for earlier clinical intervention that other approaches may miss. The NeXT Personal test achieves ultrasensitive detection of small traces of ctDNA from a patient’s blood sample using a personalized approach that tracks up to ~1,800 tumor-specific variants unique to each patient’s tumor.
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