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.


OPKO Lab is a division of OPKO Health, Inc., a multi-national pharmaceutical and diagnostic company. OPKO Health, Inc. works to establish industry-leading positions in medical markets through discovery, development, and commercialization expertise and through novel technologies. OPKO’s offerings include point-of-care diagnostics, novel molecular diagnostics, and proprietary pharmaceuticals and vaccines.

OPKO Lab is dedicated to providing Urologists and patients with accurate diagnoses within 24 hours for most tests. All clients have access to board certified, urologic fellowship trained OPKO Lab senior pathologists for consultation. OPKO Lab began in 1996 as a urologic reference laboratory providing anatomic, clinical and molecular pathology services. It was with the goal of improving these services that we developed the 4Kscore™ Test.

At OPKO Lab, we combine expert professional judgment with the most cutting-edge technology in the market in order to give urologists accurate results that guide patient care. OPKO Lab gives you more than just laboratory services – you get access to a one-stop solution for all your urologic pathology needs.

OPKO Lab works to meet your need for accurate diagnostics, expert opinions, and functional technologies. Personal client service representatives are available between 6am and 11pm CT, and clients can also receive direct consultations with and second opinions from expert pathologists.

4Kscore™ Test

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

The 4Kscore test was developed by OPKO Lab and is performed by OPKO Lab 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.