BioReference Laboratories Showcases 2019 Growth through the Addition of Cutting Edge Tests, Greater Access to Services, and Optimized Patient Experience

Press Release Quote

ELMWOOD PARK, N.J., December 19, 2019 – BioReference Laboratories, Inc., an OPKO Health Company, along with its genetics and genomics laboratory, GeneDx, Inc., and oncology, urology and women’s health division, GenPath Diagnostics, are pleased to provide a 2019 business update, highlighting new tests that lead to faster diagnoses, payer relationships that provide greater access to care, and new tools that empower patients to take responsibility of their health. Work completed by the company this year reinforces its commitment to healthcare providers, patients and payers, as well as the local community and its employees.

The healthcare industry is moving towards preventive, convenient and personalized care, and the landscape is shifting to place patients at the forefront of decisions regarding their health. As we nod to our history as a physician-led laboratory, we focused 2019 on strengthening our resources and making strategic investments that reinforce our commitment to providers and patients alike. As we celebrate this year’s accomplishments and look to the future, we’ll continue striving to empower consumers with the knowledge and tools to drive their healthcare in the most simple, accurate and efficient manner,” said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories.  

2019 Highlights Include:

  • Achieving Preferred Laboratory Network Provider status with UnitedHealthcare and a national in-network provider with Humana Inc. The new statuses provide network members convenient access to BioReference’s comprehensive test menu and helps lower patients’ out-of-pocket expenses for diagnostic testing services.
  • Announcing final positive Local Coverage Determination (LCD) for Medicare payments for the 4Kscore® test with defined coverage criteria. The LCD significantly improves access to the 4Kscore® test, which accurately determines a man’s risk of aggressive prostate cancer.
  • Unveiling a new patient portal that provides on-demand and secure access to important laboratory information, including test results, health trends, bills, and insurance. The portal empowers patients to take a more active role in their health.
  • Releasing the comprehensive respiratory profile, which rapidly and accurately detects 21 different viral and bacterial agents, leading to fewer missed detections, faster diagnosis and more accurate treatment of respiratory infections such as Influenza A, Respiratory Syncytial Virus (RSV), Bordetella pertussis (whopping cough) and Enterovirus.
  • Launching a new test for aerobic vaginitis (AV) to more accurately assess the vaginal microbiome. AV has similar symptoms and commonly co-occurs with bacterial vaginitis (BV), therefore, the new test leads to fewer missed detections, faster diagnosis, less unnecessary antibiotic use and more targeted treatment.
  • Teaming up with Meals with a Mission and Rise Against Hunger to help prepare more than 35,000 meals to those in need, and joined forces with the American Cancer Society for advocacy initiatives on a regional and national level.
  • Forbes recognition as one of America’s Best Large Employers of 2019.

About BioReference Laboratories, Inc.

BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions and medical groups.  The company is in network with the five largest health plans in the United States, operates a network of 10 laboratory locations, and is backed by a medical staff of more than 160 MD, PhD and other professional level clinicians and scientists.  With a leading position in the areas of genetics, women’s health, maternal fetal medicine, oncology and urology, BioReference and its specialty laboratories, GenPath and GeneDx, are advancing the course of modern medicine.  For more information, visit

About OPKO Health, Inc.

OPKO Health is a diversified healthcare company.  In diagnostics, its BioReference Laboratories is one of the nation’s largest full-service clinical laboratories; GeneDx is a rapidly growing genetic testing business; the 4Kscore® prostate cancer test is used to assess a patient’s individual risk for aggressive prostate cancer following an elevated PSA and to help decide about next steps such as prostate biopsy; Claros® 1 is a point-of-care diagnostics platform with a total PSA test approved by the FDA.  In our pharmaceutical pipeline, RAYALDEE is our first pharmaceutical product to be marketed.  OPK88003, a once-weekly oxyntomodulin for type 2 diabetes and obesity reported positive data from a Phase 2 clinical trial.  It’s among a new class of GLP-1/glucagon receptor dual agonists.  OPK88004, a SARM (selective androgen receptor modulator) is currently being studied for various potential indications.  The company’s most advanced product utilizing its CTP technology, a once-weekly human growth hormone for injection, successfully met its primary endpoint and key secondary endpoints in a Phase 3 study and is partnered with Pfizer.  OPKO also has research, development, production and distribution facilities abroad.  More information is available at

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements,” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning, including statements regarding our ability to improve access to the 4Kscore® test, whether the 4Kscore test accurately determines a man’s risk of aggressive prostate cancer, whether other diagnostic tests we develop lead to fewer missed detections, faster diagnosis and more accurate treatment of various disorders, or achieve other benefits,  as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.