TEST:

MyProstateScore 2.0

This is only 2.3% lower than the 18-gene MPS2, which is similar in magnitude to the 1-2% in uncertainty induced by different data preprocessing choices. The 7-gene sMPS2 provides a unique opportunity to expand the reach and adoption of non-invasive PCa screening.

Using first-catch urine, MPS2 meaningfully improved the proportion of biopsies avoided relative to PCPTrc while maintaining highly-sensitive detection of GG≥2 cancer. Non-DRE testing provides a convenient, objective, and highly-accurate testing option to reduce the need for imaging and biopsy in men with elevated PSA.

Using urine obtained without DRE, MPS2 testing provided very high sensitivity and NPV for ruling out GG≥2 cancer. Importantly, the baseline (i.e. biomarker-only) MPS2 model demonstrated clinically significant improvement in diagnostic accuracy relative to PSA-based testing, with further improvements observed with inclusion of optional clinical data.

"Lynx Dx...published today in the Journal of the American Medical Association (JAMA) Oncology that validates the efficacy of MyProstateScore 2.0 (MPS2), the company's groundbreaking prostate cancer risk assessment test....Key findings from the paper include: MPS2 was clinically validated separately in patients presenting for initial biopsy (i.e., biopsy naïve) and those presenting for a repeat biopsy (i.e., prior negative biopsy). Use of the test would safely identify 42% to 51% of patients who would not have clinically significant prostate cancer found on biopsy, while maintaining high sensitivity for high-grade cancers. The test was validated for use as a biomarker-only test or inclusive of optional clinical risk factors."