Accurate prediction of clinical benefit (complete response, partial response or stable disease) to physician-selected treatment among among enrolled patients with mCRC

The primary objective is to determine the accuracy of clinical benefit prediction by xDRIVE testing in participants with advanced CRC who receive SOC therapies. Response to SOC therapy will be determined by RECIST guidelines, with disease response measured through radiographic imaging. Accurate prediction of RECIST-determined clinical response (complete response, partial response, stable disease, or progressive disease) by xDRIVE tumor in 20 of 25 participants (80%) is sufficient to reject the null hypothesis (≤50% accuracy) with 90% power (α = 0.05). Enrollment will be a total of 30 subjects.

Tumor measurements will be taken at baseline before treatment and at the first post-treatment scan. RECIST will be used to assess response. Outcomes will be tracked for the duration of the study, up to one year.

Feasibility of returning xDRIVE functional precision medicine data in a clinically-actionable timeframe

The secondary objective is to determine the feasibility of using xDRIVE to provide treatment recommendation in a clinically-actionable timeframe. Feasibility will be demonstrated if treatment recommendations are returned within 4 weeks for at least 16 of 25 patients (64%), which is sufficient to reject the null hypothesis (≤35% treatment recommendations) with 90% power (α = 0.05).

Timeframe for successful return of data is within 4 weeks. Previous studies have demonstrated a median 10-day turnaround time.