What is the ExoDx™ Prostate Test?
The ExoDx™ Prostate Test is a simple, non-DRE, urine-based, liquid biopsy test indicated for men 50 years of age and older with a prostate-specific antigen (PSA) 2-10ng/mL, or PSA in the “gray zone”, considering an initial biopsy. The ExoDx Prostate test returns a risk score that determines a patient’s risk of clinically significant prostate cancer (Gleason Score ≥7) on prostate biopsy. A score above the validated cut-point of 15.6 is associated with an increased likelihood of GS≥7 PCa on a biopsy and a score below the cut-point of 15.6 is associated with a decreased likelihood of GS≥7 PCa. This test can help reassure a patient to avoid a prostate biopsy or improve patient compliance with physician recommendation.
Based on compelling results from these two well-designed prospective clinical validation studies and an ongoing innovative utility and cost-effectiveness trial conducted in collaboration with CareFirst BlueCross BlueShield, both private and public payors have made positive coverage decisions for The ExoDx Test.
- The National Comprehensive Cancer Network (NCCN) include ExoDx in the May 2019 Prostate Cancer Screening Guidelines (NCCN V2.2019) for early detection of prostate cancer in men for both initial and prostate biopsy (www.nccn.org)
- The ExoDx test was granted FDA Breakthrough Designation in June 2019. This is the first of its kind for a liquid biopsy test. EXODX addresses an area of unmet medical need and represents breakthrough technology.
- On October 10, 2019, Medicare Administrative Contractor (MAC) National Government Services, Inc. issued a final Local Coverage Decision (LCD) L37733, covering the ExoDx Prostate test for men who are being considered for an initial prostate biopsy. The decision is effective for tests administered on or after December 1, 2019. Following the LCD finalization, more than 5.5 million Medicare beneficiaries may now be covered for the ExoDx test effective December 1, 2019.