OPKO Health’s BioReference Laboratories and GeneDx Increase COVID-19 Response Through Expanded Testing Capacity

GeneDx’s Gaithersburg and BioReference’s Melbourne facilities offer COVID-19 testing

ELMWOOD PARK, N.J., April 20, 2020 – BioReference Laboratories, Inc., an OPKO Health company (NASDAQ: OPK), today announced its subsidiary GeneDx will begin testing for COVID-19 to further expand public access to testing. In addition, BioReference will leverage its Melbourne, Florida facility to increase COVID-19 testing capacity, especially in the Florida region.

“Leveraging the diagnostic expertise at GeneDx and our Florida laboratory allows BioReference to increase access to COVID-19 testing nationwide and continue to support frontline healthcare professionals and public health authorities to more quickly identify infected patients and subsequently limit the spread of infection,” said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. “During these unprecedented times, we must be nimble to address and mobilize an effective public health response.”

GeneDx and the Melbourne, Florida facility will offer the same technology as BioReference’s headquarters in Elmwood Park, to help ensure patients and providers have greater access to testing in the effort to promote earlier diagnosis and help limit spread of infection.

“GeneDx is excited to rise to the challenge and bring up COVID-19 testing in this critical time of need to ensure patients receive appropriate care and to help contain the spread of the virus,” said Sean Hofherr, Ph.D., FACMG, Chief Scientific Officer and CLIA Laboratory Director of GeneDx. “GeneDx traditionally focuses on genomics, with a mission to provide optimal care and expertise for patients in need; this mission remains the same while combating COVID-19. We would also like to acknowledge the generosity of Montgomery College who has generously provided several biosafety cabinets, which are crucial in keeping employees safe while handling COVID-19 samples.”

Providers should refer to the most current CDC guidelines for further information on appropriate testing of patients, available here https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-criteria.html.

About COVID-19 Testing at BioReference Laboratories, Inc.
BioReference Laboratories is accepting specimens for COVID-19 testing from healthcare providers, clinics and health systems throughout the United States to promote earlier diagnosis of the coronavirus and to aid in limiting spread of infection. In addition to its nationwide COVID-19 testing offering, BioReference has partnerships with the New York State Department of Health, the New York City Health and Hospital Corporation (NYC Health + Hospitals), the State of New Jersey, the State of Florida and the cities of Detroit and Miami to provide COVID-19 testing.

BioReference is offering a real-time reverse-transcription polymerase chain reaction (real-time RT-PCR) assay with expected 24-72 hour turnaround time. The Novel Coronavirus COVID-19 test has been made available pursuant to the U.S. Food and Drug Administration Emergency Use Authorization for diagnostic testing in CLIA certified high-complexity laboratories. All tests are conducted in BioReference’s main laboratory in Elmwood Park, N.J., which currently has a capacity to run up to 20,000 COVID-19 tests per day. For more information, visit https://www.bioreference.com/coronavirus

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. For more information, visit www.bioreference.com.

About GeneDx, Inc.

GeneDx, Inc. is a global leader in genomics, providing testing to patients and their families from more than 55 countries. Led by its world-renowned whole exome sequencing program, GeneDx has an acknowledged expertise in rare and ultra-rare genetic disorders, as well as one of the broadest menus of sequencing services available among commercial laboratories. GeneDx offers a suite of additional genetic testing services, including diagnostic testing for hereditary cancers, cardiac, mitochondrial, neurological disorders, prenatal diagnostics and targeted variant testing. GeneDx is a subsidiary of BioReference Laboratories, Inc., a wholly owned subsidiary of OPKO Health, Inc. To learn more, please visit www.genedx.com.

About OPKO Health
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® 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.

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 BioReference’s testing for COVID-19 and the timing of and availability of the test, the expected daily capacity for testing, the ability to expand our test capacity, our ability to increase COVID 19 testing availability nationwide, as well as the timeline for doing so, and the expected turnaround time for testing of hospital and non-hospital patients, 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 equipment and reagent shortages, 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

Media contact for BioReference Laboratories and GeneDx:

Hillary Titus, htitus@bioreference.com