Opko Health, Inc. · NASDAQ:OPK
Opko Health — Technical Presentation (August 2015)
14 slides from Opko Health's technical presentation, Aug 7, 2015
Slide 1: The 4Kscore blood test for risk of aggressive prostate cancer
The 4Kscore® blood test for risk of aggressive prostate cancer
Slide 2: Early detection of aggressive prostate cancer
Early detection of aggressive prostate cancer Challenges • Serum PSA has a high false positive rate • Over 1 million prostate biopsies performed annually in US • 75% biopsies will have low-grade, indolent (Gleason 6) or no prostate cancer • Serious complications of biopsies include infection and hos
Slide 3: The 4Kscore Test
The 4Kscore Test • The only blood test that accurately identifies risk for aggressive prostate cancer • Aggressive prostate cancer is defined by both high-grade disease and long term clinical outcomes (rate of prostate cancer metastases) • Based on 10 years of work by scientists at Memorial Sloan-Ke
Slide 4: 2015 NCCN Prostate Cancer Early Detection Guidelines
2015 NCCN Prostate Cancer Early Detection Guidelines
Slide 5: What is the 4Kscore Test?
What is the 4Kscore Test? Components Results Total PSA % risk of having Free PSA aggressive prostate OPKO ALGORITHM cancer for an Proprietary to OPKO { Intact PSA hK2 individual patient + Age, DRE, and prior biopsy status
Slide 6: 4Kscore Test: 10 years of clinical research conducted by Memorial Sloan Kettering Cancer Center
4Kscore Test: 10 years of clinical research conducted by Memorial Sloan Kettering Cancer Center and leading international cancer centers
Slide 7: Prospective, blinded, multicenter US study validates 4Kscore Test
Prospective, blinded, multicenter US study validates 4Kscore Test • 1,012 patients enrolled in 26 academic and community practices • Referred for biopsy regardless of age, 26 Clinical study sites PSA, clinical findings or prior biopsy status • Minimum of 10 core TRUS-guided biopsies performed • The
Slide 8: Gleason score distribution in Prospective US Study
Gleason score distribution in Prospective US Study Negative or Gleason 6 prostate cancer Aggressive (Gleason ≥ 7) prostate cancer
Slide 9: The 4Kscore Test has the greatest accuracy for predicting aggressive prostate cancer
The 4Kscore Test has the greatest accuracy for predicting aggressive prostate cancer Sensitivity AUC = area under the curve 4Kscore AUC = 0.82 1 Larger AUC = better accuracy PSA for predicting aggressive AUC = 0.69 1 prostate cancer AUC of other tests when AUC = 0.5 applied to aggressive disease PHI
Slide 10: The risk of aggressive prostate cancer predicted by the 4Kscore Test is confirmed by biopsy
The risk of aggressive prostate cancer predicted by the 4Kscore Test is confirmed by prostate biopsy 239 aggressive prostate cancers detected in 1,012 subjects
Slide 11: 4Kscore Test is more accurate than total PSA alone in predicting aggressive prostate cancer
4Kscore Test is more accurate than total PSA alone in predicting aggressive prostate cancer in subset of men with PSA 16-20ng/mL
Slide 12: The 4Kscore Test predicts the probability of distant metastases within 20 years
The 4Kscore Test predicts the probability of distant metastases within 20 years 4Kscore Test Biomarkers 4Kscore > 7.5% (N =1510, 62%) > 7.5% 5 year = 2.4% 10 year = 5.6% 15 year = 9.9% all men 20 year = 16.4% PSA ≥ 3 all men PSA ≥ 3 4Kscore Test Biomarkers 7.5% (N = 922, 38%) 4Kscore ≤ 7.5% 5 year
Slide 13: Clear result reporting for informed decision making
Clear result reporting for informed decision making 4Kscore = Personal Positive Predictive Value
Slide 14: The 4Kscore Test Summary
The 4Kscore Test Summary • Included in the 2015 NCCN Guidelines for Prostate Cancer Early Detection • Clinical utility was validated based on a decade of research in over 22,000 men in Europe and the United States • Identifies the risk of aggressive prostate cancer for the individual patient • High