ABSTRACT
INTRODUCTION AND OBJECTIVE: COVID-19 led to paradigm shifts in telemedicine due to patient's fear of office visits and travel avoidance. With widespread cancellation of office visits and reduction of diagnostic biopsy procedures in men with elevated PSAs, the need for a non-invasive/non-DRE At Home Collection Kit for assessing risk of aggressive prostate cancer and to prioritize biopsy procedures became apparent. We adapted the existing ExoDx Prostate (EPI) office liquid biomarker kit into an At Home Collection Kit physician/ patient shared decisions for prostate biopsy. METHOD(S): A 2-stage program for an At Home Collection Testing Kit program for the ExoDx Test was initiated in April 2020 at the onset of the COVID-19 pandemic. The Phase 1 Pilot study (100 patients, 6 sites) was completed in June 2020. Based on the findings in the pilot, the program was streamlined based on feedback from physicians, patients, and office mangers before making it available in Phase 2 to all urologists in the US. The utilization of the At Home Collection Kits have been measured. RESULT(S): Extensive feedback from the pilot program led to improvements and streamlining before the Phase 2 rollout. As of October 31st, 2022, >30% of all the ExoDx Prostate Tests are At Home Collection Kits. EPI Score distributions are identical (mean 28.4 and 29.7), (median 23.0 and 24.7) in home or clinic sample collection respectively (Figure 1). CONCLUSION(S): The COVID-19 pandemic accelerated major shifts to telehealth and increased use of At Home Testing. The ExoDx Prostate (EPI) At Home Collection Kit was successfully developed and employed to help men (>50 years old) with elevated PSAs (2-10 ng/ml) considering initial or repeat diagnostic biopsy but with pandemic-related fears of visiting offices/hospitals or wanting to avoid long distance travel from rural areas. As COVID becomes manageable and clinical practices have opened, some pandemicadopted approaches remain relevant: the ExoDxTM Prostate, (EPI) At Home Collection Kit is one such approach.