OPKO’s GeneDx Subsidiary and North Shore-LIJ Health System Form Strategic Alliance for Genetic Testing

MIAMI, Dec. 14, 2015 /PRNewswire/ — The North Shore-LIJ Health System and OPKO Health, Inc. (NYSE: OPK) have formed a novel strategic alliance to provide genomic testing, molecular diagnostic testing and ancillary support services such as genetic counseling.  The scope of testing will cover all genetic disorders, including prenatal screening, pediatric and postnatal diagnosis, assessing risk for inherited cancer, and testing for genetic cardiac abnormalities and neurological disorders.  It will also include genetic analysis of cancer for sensitivity to drug therapies.

An essential element of the strategic alliance is the formation of a limited liability corporation (LLC). Its purpose will be to generate knowledge leading to new discoveries from a shared data infrastructure consisting of fully annotated genomic data with detailed clinical information, which will help build the evidence base for the medical necessity of genomic and genetic testing.

“The purpose of this alliance is to advance the promise of precision medicine by providing our patients with greater access to these potentially life-saving tests, while at the same time evaluating their utility and clinical value,” said James Crawford, MD, PhD, chair of pathology and executive director of laboratory services at the North Shore-LIJ Health System, which is changing its name in January to Northwell Health.

North Shore-LIJ is a rapidly growing clinical, education and research enterprise that is a leader in quality and innovation.  It currently ranks as the nation’s 14th-largest health system, with annual operating revenues of $9.5 billion.   As a fully integrated healthcare system serving the greater New York metropolitan area and beyond, North Shore-LIJ has more than four million patient contacts in its 21 hospitals, over 450 outpatient physician practices, and a vast network of skilled-nursing, home care, rehabilitation, hospice, urgent care and other services.   In addition to the North Shore-LIJ Cancer Institute and the health system’s extensive prenatal care programs, North Shore-LIJ’s Cohen Children’s Medical Center cares for thousands of children with a wide range of pediatric diseases; including genetic abnormalities, who will benefit from genomic tests.  Through this alliance, North Shore-LIJ will utilize OPKO’s GeneDx and GenPath divisions as its primary laboratory for genomic testing.

“We are pleased to be partnering with North Shore-LIJ to leverage our collective expertise, experience and resources in genomics and clinical care to further expand access to targeted treatment options for patients,” said Marc Grodman, MD, Chief Executive Officer of OPKO’s BioReference Laboratories division. “The leadership of North Shore-LIJ has demonstrated a visionary approach to incorporate genomics in a coordinated, strategic manner throughout its health system. Our GeneDx and GenPath business units have extensive capabilities that will be leveraged in this alliance to further enhance NSLIJ patient care, education and research.”

Michael Dowling, President and CEO of North Shore-LIJ, said, “The breadth of care provided by our health system gives us the opportunity to advance clinical knowledge through genomic testing. Linking genomic information with clinical outcomes is critical to understanding, diagnosing and treating disease. This strategic alliance with GeneDx and BioReference in genomics will further elevate our stature as a premier provider and destination for world-class care.”

About North Shore-LIJ Health System — North Shore-LIJ is changing its name to Northwell Health in January 2016.
One of the nation’s largest health systems, the health system delivers world-class clinical care throughout the New York metropolitan area, pioneering research at The Feinstein Institute for Medical Research, a visionary approach to medical education highlighted by the Hofstra North Shore-LIJ School of Medicine, and healthcare coverage to individuals, families and businesses through the CareConnect Insurance Co. Inc. The health system cares for people at every stage of life at 21 hospitals and about 450 outpatient physician practices throughout the region. The health system’s owned hospitals and long-term care facilities house more than 6,600 beds, employ more than 15,000 nurses and have affiliations with nearly 13,600 physicians. With a workforce of more than 61,000, the health system is the largest private employer in New York State.  For more information, go to www.northshorelij.com

About OPKO Health, Inc.:
OPKO Health, Inc. is a diversified healthcare company that seeks to establish industry-leading positions in large, rapidly growing markets. Our diagnostics business includes Bio-Reference Laboratories, the nation’s third-largest clinical laboratory with a core genetic testing business and a 420-person sales force to drive growth and leverage new products, including the 4Kscore® prostate cancer test and the Claros®1 in-office immunoassay platform. Our pharmaceutical business features Rayaldee™, a treatment for SHPT in stage 3-4 CKD patients with vitamin D insufficiency (March 29, 2016 PDUFA date) and VARUBI™ for chemotherapy-induced nausea and vomiting (oral formulation launched by partner Tesaro, IV formulation in Phase 3). Our biologics business includes hGH-CTP, a once-weekly human growth hormone injection (in Phase 3 and partnered with Pfizer), and a long-acting Factor VIIa drug for hemophilia (entering Phase 2a). We also have production and distribution assets worldwide, multiple strategic investments and an active business development strategy. More information is available at www.opko.com.

About GeneDx:
GeneDx and its parent company BioReference Laboratories Inc. are members of the OPKO Health, Inc. (NYSE: OPK) group of companies. GeneDx is a world leader in Genomics with 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 performs more clinical Whole Exome Sequencing tests than any other diagnostic lab in the world. The GeneDx mission is to make clinical testing affordable and available to people with rare genetic conditions and their families. GeneDx provides testing to patients and their families in more than 55 countries. To learn more, please visit www.genedx.com.


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 expected benefits of the collaboration, the facilitation of wide-scale adoption of genomic based testing through the NSLIJ health system, the parties’ ability to generate knowledge and new discoveries from a shared data structure, the ability to expand access to targeted treatment, whether NSLIJ will outsource its genetic testing business to BioReference, the ability to successfully identify novel disease genes that cause rare genetic disorders, 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 our filings with the Securities and Exchange Commission, as well as the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. 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.

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SOURCE North Shore-Long Island Jewish Health System

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