4Kscore™ Prostate Cancer Test

4Kscore™ is a next-generation prostate cancer test

• Based on the following panel of kallikrein markers:
  • Total PSA
  • Free PSA
  • Intact PSA
  • Human Kallikrein 2 (HK2)
• Enabling IP exclusively licensed from Arctic Partners (Finland)
• In May 2012, OPKO licensed to International Health Technology, Ltd. (Cambridge, England), the right to offer 4Kscore™’s panel of novel kallikrein biomarkers in laboratory settings in the U.K., Ireland, Sweden, and Denmark.
• In October 2012, IHT launched 4Kscore™ in Europe, where the panel was recently featured in U.K. media.
• OPKO is developing a point-of-care version of the 4Kscore™ biomarker panel.

Predicts indolent versus aggressive prostate cancer

• A panel combining our PSA test and our novel kallikrein markers could create a diagnostic test able to accurately predict prostate cancer-positive biopsies

Could lead to a 50% decrease in unnecessary prostate biopsies

• 750,000 unnecessary prostate biopsies are performed annually in the US

Kallikrein markers have been tested in over 10,000 patients:

• Kallikrein panel predicts biopsy results in previously unscreened men with elevated PSA
  “A Panel of Kallikrein Markers Can Reduce Unnecessary Biopsy for Prostate Cancer: Data from the European Randomized Study of Prostate Cancer Screening in Göteborg, Sweden”
• Prior participation in PSA screening dramatically impacts biopsy predictions
  “Impact of Recent Screening on Predicting the Outcome of Prostate Cancer Biopsy in Men with Elevated PSA: Data from the European Randomized Study of Prostate Cancer Screening in Gothenburg, Sweden”
• Rotterdam replication of Gothenburg study
  “Reducing Unnecessary Biopsy During Prostate Cancer Screening Using a Four-Kallikrein Panel: An Independent Replication”
• Replication of Rotterdam study
  “A Four-Kallikrein Panel Predicts Prostate Cancer in Men with Recent Screening: Data from the European Randomized Study of Screening for Prostate Cancer, Rotterdam”
• External validation of Rotterdam study
  “A Four-Kallikrein Panel for the Prediction of Repeat Prostate Biopsy: Data from the European Randomized Study of Prostate Cancer Screening in Rotterdam, Netherlands”
• Biopsy outcomes predicted based on clinical work-up in addition to elevated PSA
  “A Panel of Kallikrein Markers Can Predict Outcome of Prostate Biopsy Following Clinical Work-Up: An Independent Validation Study from the European Randomized Study of Prostate Cancer Screening, France”
• Men predicted “low risk” by kallikrein panel unlikely to develop incurable prostate cancer
  “A Panel of Kallikrein Marker Predicts Prostate Cancer in a Large, Population-Based Cohort Followed for 15 Years Without Screening”