Highlights

  • Post-therapy ctDNA detection linked to ~10x increased relapse risk in TNBC patients.
  • 48% of ctDNA-positive cases had levels under 100 PPM, stressing test sensitivity.
  • Post-surgical ctDNA detection correlated with >85x increased recurrence likelihood.

Personalis, Inc. (Nasdaq: PSNL) announced new clinical data from the PREDICT DNA and SCANDARE studies at the ASCO 2025 Annual Meeting, presenting findings that suggest its NeXT Personal™ ctDNA test could serve as a significant prognostic tool for patients with triple negative breast cancer (TNBC) undergoing neoadjuvant therapy (NAT).

The PREDICT DNA study evaluated ctDNA in early-stage HER2-positive and TNBC patients. Conducted across 22 U.S. sites over a decade, the trial included 228 patients and was powered to assess the prognostic relevance of ctDNA in predicting pathological complete response (pCR) and relapse-free survival (RFS).

Key findings showed that patients with detectable ctDNA following NAT were approximately 10 times more likely to experience relapse than those who were ctDNA-negative, regardless of pCR status. Furthermore, post-surgical ctDNA detection was associated with an 85-fold increased likelihood of recurrence, underscoring its potential as a critical indicator of residual disease and long-term risk.

Nearly 48% of positive ctDNA results fell below 100 parts per million (PPM), demonstrating the importance of NeXT Personal’s ultrasensitive detection capabilities in identifying minimal residual disease.

The SCANDARE study results, alongside PREDICT DNA, support the potential use of ultrasensitive ctDNA assays in identifying patients who may require adjusted adjuvant therapy strategies. These insights could inform clinical decisions on therapy escalation or de-escalation based on individualized risk profiles derived from ctDNA levels.

Personalis stated that once these results are published, they may support efforts to seek reimbursement coverage for ctDNA monitoring in breast cancer treatment. The company plans further collaboration with research institutions to expand evidence for NeXT Personal’s use in oncology.