Diagnostics Overview

Cytochroma, Inc.

On January 8, 2013, OPKO announced that it has signed a definitive agreement to acquire all of the assets of Cytochroma, Inc.

OPKO intends to market Cytochroma’s portfolio of products, including the vitamin D treatment Rayaldy™, along with OPKO’s proprietary point-of-care vitamin D diagnostic test currently in development.


OPKO has completed its acquisition of OURLab, a Nashville-based CLIA laboratory. OURLab operates 18 phlebotomy sites throughout the United States and maintains an experienced national sales force aimed primarily towards urologists. In addition to providing independent laboratory testing services, OURLab is strategically positioned as OPKO’s commercial platform for the anticipated U.S. launch of 4Kscore™, a prostate cancer biomarker panel.

Point-of-Care Diagnostics

In October 2011, OPKO acquired Claros Diagnostics, Inc., now OPKO Diagnostics, a company that 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.

Molecular Diagnostics

In June 2009, OPKO acquired exclusive, worldwide rights from the University of Texas Southwestern to an innovative platform technology for the rapid identification of disease-specific antibodies that can serve as diagnostic biomarkers for various diseases.

This technology may be useful for creating:
- Accurate, easy-to-use diagnostic tests
- Vaccines
- Targeted therapeutic agents for immune system-driven diseases

It can be implemented on a variety of platforms, including:
- Microarrays
- ELISA (enzyme-linked immunosorbent assays)
- Flow Cytometry

OPKO’s Biomarker Discovery Team expects this technology to apply to numerous disease areas where no widely accepted or effective screening tests are currently available. The first diagnostic product we are pursuing using this technology is a simple blood test for Alzheimer’s disease.