December 21, 2015 8:30am EST
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Largest Published Study to Date Supports Testing Changes and
Development of New Treatment Options
MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE: OPK) through its subsidiary GeneDx, today
announced results from the largest published study to date of patients
who received hereditary genetic testing with Next Generation Sequencing
(NGS) cancer panels. The study, “ Pathogenic and Likely Pathogenic
Variant Prevalence among the First 10,000 Patients Referred for Next
Generation Cancer Panel Testing,” was published in the December 2015
issue of Genetics in Medicine. GeneDx’s analysis of the data generated
from the first 10,030 patients highlights the clinical utility of
testing for multiple cancer genes to identify variants that would not
have been identified through previously used testing methods. The
patients, who were referred for testing between August, 2013 and
October, 2014, underwent genetic testing for panels of genes associated
with hereditary cancer.
While many patients were found to carry pathogenic or likely pathogenic
variants in well-established, high-risk cancer genes, approximately half
of the pathogenic variants identified were in genes with moderate risk
and in recently identified cancer genes. Notably, among women with
breast cancer, 50% of positive findings were in genes other than BRCA1
or BRCA2 . Additionally, several individuals had pathogenic
variants in high-risk genes that were somewhat unexpected, so clinical
presentation alone might not have prompted testing for these genes.
“We believe that molecular diagnostic testing for panels containing
multiple genes are significantly more accurate in determine the
heritable factors which increase the risk of cancer, and may permit more
tailored treatment for cancer patients and screening for their family
members,” said Sherri Bale, PhD, FACMG, Co-Founder and Managing Director
of GeneDx. “Our experience, based on a large database of patients,
demonstrates that multi-gene panels have the potential to identify
pathogenic variants in genes that would not typically have been tested
and most likely would have been missed. This study provides important
empirical data for clinical decision-making when choosing between single
genes and NGS cancer panel testing for a variety of cancers.”
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
Reade™, 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 .
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 NGS cancer panels, the ability
to accurately determine the heritable factors increasing the risk of
cancer, permitting tailored treatment, screening and prevention of
cancer in 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 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20151221005547/en/
OPKO Health, Inc .
Carly Erickson, 202-600-4558
or
Tara
Mackay, 305-575-4100
Investor Relations
or
Media
Rooney
& Associates
Terry Rooney, 212-223-0689
or
Marion
Janic, 212-223-4017
or
Investors
LHA
Anne
Marie Fields, 212-838-3777
or
Bruce
Voss, 310-691-7100
Source: OPKO Health, Inc.
Released December 21, 2015
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