At the ASCO Personalis, I presented data demonstrating that the NeXT Personal test had exceptional detection rates and performance for early-stage breast cancer. The NeXT Personal test represents the first of a new class of ultra-sensitive liquid biopsy tests designed to detect the earliest traces of cancer recurrence and monitor a patient’s response to therapy. Capable of detecting circulating tumor DNA (ctDNA) down to an ultra-sensitive range (<100 parts per million of ctDNA), the data highlighted at ASCO underscore the clinical importance of this approach.

Key Findings:

• NeXT Personal’s Ultra-sensitive range enabled earlier detection of recurrence, with a median ~15-month lead time over imaging detection

• 100% of patients that recurred were detected with NeXT Personal and 100% of patients that were ctDNA negative on longitudinal testing were cancer-free

• NeXT Personal enabled detection of shallow traces of cancer, with ~39% of all detections falling in the ultra-sensitive range below 100 PPM (below 0.01% of ctDNA)

• NeXT Personal enabled substantially better sensitivity and lead times compared to other MRD assays on the same patient cohort

Conclusion

The study concluded that an ultrasensitive detection method using a bespoke whole-genome sequencing-based tracking assay enhances the detection of ctDNA at baseline and during follow-up, providing an increased lead time over clinical relapse. Detecting ctDNA during follow-up is strongly associated with worse relapse-free and overall survival. Furthermore, an ultrasensitive detection assay can identify early MRD+ patients who clear ctDNA and do not relapse during long-term follow-up, the underlying biology of this phenomenon is not yet understood.