OPKO's GeneDx Subsidiary And North Shore-LIJ Health System Form Strategic Alliance For Genetic Testing

Collaboration will drive the use of medically necessary genomic testing to improve patient care

The North Shore-LIJ Health System and OPKO Health, Inc. 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) whose 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.

“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. An essential element of the strategic alliance is the creation of a shared data infrastructure to link annotated genomic data with detailed clinical information, which will help build the evidence base for the medical necessity of such testing.

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 $9.5B. 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.” continued Dr. Grodman.

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, visit 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 Claros1 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. For more information, visit www.opko.com.

About GeneDx
GeneDx and its parent company BioReference Laboratories Inc. are members of the OPKO Health, Inc. 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. For more information, visit www.genedx.com.