ProstateDx™
A Blood-Based Test for Clinically Significant Prostate Cancer
ProstateDx™ is a non-invasive diagnostic assay designed to detect circulating tumor cells associated with clinically significant prostate cancer, supporting earlier and more informed clinical decision-making.
Clinical Use
Intended Use: Patients with elevated PSA
• Pre-biopsy decision support
• Risk stratification
Value
• Reduces unnecessary biopsies
• Improves detection of aggressive disease
• Enhances patient experience
ProstateDx™ is a laboratory-developed test (LDT) and has not been cleared or approved by the U.S. Food and Drug Administration (FDA). Testing is performed in CLIA-certified laboratories.
ProstateDx™ is a laboratory developed test (LDT) and has not been cleared or approved by the U.S. Food and Drug Administration (FDA). Testing is performed as a laboratory developed test (LDT) under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to conduct high-complexity testing.