Diagnostics Overview

BioReference Laboratories

BioReference is the third largest full service clinical diagnostic laboratory in the U.S. providing testing and related services to physician offices, clinics, hospitals, long term care facilities, employers, governmental units and correctional institutions. We offer a comprehensive test list focusing on molecular diagnostics, anatomical pathology, genetics, and women’s health. Moreover, through its GeneDx subsidiary, BioReference has an international presence in more than 50 countries around the world.

4Kscore™ Test

Personal risk for high-grade prostate cancer … from a blood test

The 4Kscore test was developed by OPKO and is performed by BioReference at its CLIA-accredited laboratory facility. The 4Kscore Test relies on the measurement of four prostate-specific kallikreins in blood: Total PSA, Free PSA, Intact PSA, and Human Kallikrein 2 (hK2). The blood test results are combined in an algorithm with patient age, DRE (nodules, no nodules), prior negative biopsy (yes/no). The result is a patient specific probability for finding a high-grade, Gleason score 7 or higher prostate cancer upon biopsy.

Claros® 1 Analyzer and SangiaTM Microfluidic Assay Cassettes

Claros 1 has developed a microfluidics-based device consisting of a disposable, credit-card-sized test cassette and a small but sophisticated desktop analyzer. The cassette requires only a finger-stick drop of blood before the analyzer can simultaneously run up to 20 separate tests, producing lab-quality results in about 10 minutes.

OPKO Diagnostics expects to integrate this point-of-care system with the molecular diagnostics platform developed by OPKO’s Biomarker Discovery Team, facilitating the production of rapid, quantitative test results for several difficult-to-diagnose conditions.

This development has the potential to revolutionize the field of medical diagnostics, eliminating long lab result wait times for patients and yielding greater clinical efficiency and cost effectiveness for practitioners.