OPKO Health, Inc. (NASDAQ:OPK), announces today
that GeneDx, Inc., a subsidiary of OPKO’s BioReference
Laboratories, has entered into a research collaboration with the
Radboud University Medical Center, Nijmegen,
Netherlands. Through the agreement, GeneDX and Radboud aim to
identify novel genes and pathways to help understand the causes,
clinical characteristics, and eventual management of human genetic
diseases. Additionally, the project will improve informatics and
statistical methods to robustly and rapidly diagnose patients with
genetic conditions.
GeneDx, an industry leader in whole exome sequencing (WES),
launched its WES program in 2011. Over the past five years,
work at GeneDx has helped discover or contribute to the phenotypic
understanding of dozens of novel disease genes associated with
developmental delay or intellectual disability. With this newest
research collaboration, the study cohort will expand with
approximately 3,000 additional cases* from Radboud, thus creating
the largest combined data set of neurodevelopmental exomes for
genetic analysis and discovery.
“The opportunity to collaborate with Radboud is yet another
exciting advancement for our WES program,” said Kyle Retterer,
Chief Innovation Officer of GeneDx and co-principal investigator
for the collaboration. “The shared combination of our data
summaries and analytical tools to conduct meta-analyses of GeneDx
and Radboud datasets will help us better understand the genetic
basis of neurological health and disease.”
Radboud’s key strength is the combination of medical life
sciences and clinical practice. The medical center has an
infrastructure comprised of three research institutes and state of
the art technology centers. The center’s scientists perform cross
disciplinary research regarding 18 clinically relevant research
themes.
“With this collaboration we hope to expand our knowledge of
neurodevelopmental disorders and provide better diagnoses to our
patients,” said Christian Gilissen, Associate Professor at the
Radboud University Medical Center and principal investigator for
the collaboration. “We are pleased to work with GeneDX on this
project.”
To learn more about Radboud University Medical Center research
please visit its website at www.radboudumc.nl/research. For
GeneDx’s complete list of testing options, please visit its
website www.genedx.com or email
genedx@genedx.com.
*GeneDx will not share individual patient level data as part of
this collaboration. Additionally, if this research results in
publication, GeneDx will only include patients where explicit
consent for publication has been obtained.
About GeneDx
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. Providing testing to patients and their
families in more than 55 countries, 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, Inc.
OPKO Health is a diversified healthcare company that seeks to
establish industry leading positions in large, rapidly growing
markets. Our diagnostics business includes BioReference
Laboratories, the nation's third largest clinical laboratory with a
core genetic testing business and a 400 person sales and marketing
team 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, an FDA approved treatment for SHPT in stage 3-4 CKD
patients with vitamin D insufficiency (launched in November 2016),
VARUBI® for chemotherapy-induced nausea and vomiting (oral
formulation and IV forms marketed by partner, TESARO); OPK88003, a
once-weekly oxyntomodulin for type 2 diabetes and obesity that is a
clinically advanced drug candidate among the new class of GLP-1
glucagon receptor dual agonists, and OPK88004, a selective androgen
receptor modulator being developed for benign prostatic hypertrophy
and other urologic and metabolic conditions. 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 in Phase 2a. We also have various production
and distribution assets abroad, multiple strategic investments and
an active business development strategy. More information is
available at www.opko.com.
SAFE HARBOR STATEMENT
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 with Radboud, our ability to
identify novel genes and pathways and improve informatics and
statistical methods to robustly and rapidly diagnose patients with
genetic conditions, 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.
CompanyDavid Malina, 305-575-4100Investor Relations
or
Jane Juusola, PhD, FACMG, 201-791-2600 x6148Director of the
Clinical Genomics Program
or
Ben Solomon, MD, FACMG, 301-519-2100 x6329Managing Director,
GeneDx
InvestorsLHAAnne Marie Fields, 212-838-3777afields@lhai.com
or
Bruce Voss, 310-691-7100bvoss@lhai.com
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