Personalis publishes breast cancer study in Journal of Clinical Oncology
Personalis Inc. (NASDAQ: PSNL) announced the publication of its PREDICT-DNA study in the Journal of Clinical Oncology. The study examined the use of the company's NeXT Personal test for monitoring molecular residual disease in breast cancer patients receiving neoadjuvant therapy.
The prospective study tracked 227 patients with Triple-Negative and HER2+ breast cancer across more than 24 U.S. cancer centers. Results showed that 55% of circulating tumor DNA detections following neoadjuvant therapy occurred at levels below 100 parts per million.
According to the study, patients with detectable circulating tumor DNA after neoadjuvant therapy showed a 4 to 9 times higher likelihood of cancer relapse. The test detected circulating tumor DNA at sensitivity levels of 1 to 3 parts per million.
"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," said Richard Chen, Chief Medical Officer at Personalis.
The study found that circulating tumor DNA status outperformed traditional metrics including nodal status, tumor grade, and pathologic complete response status in multivariate analyses. Patients with detectable circulating tumor DNA up to 12 months post-surgery were more than 100 times more likely to experience disease recurrence.
Dr. Ben Park, Director of the Vanderbilt-Ingram Cancer Center, said the results show that patients who clear their circulating tumor DNA demonstrate good outcomes regardless of pathologic complete response status.
The NeXT Personal test tracks up to approximately 1,800 tumor-specific variants unique to each patient's tumor using blood samples. The company stated the findings support expanding reimbursement for the test in neoadjuvant monitoring applications.
