OPKO Health, Inc. (NASDAQ:OPK) announces that GenPath Women’s
Health, a business unit of OPKO Health subsidiary BioReference
Laboratories, will offer ClariTest™, a non-invasive prenatal test
(NIPT) initially to be performed at Illumina, Inc. (NASDAQ:ILMN) on
the Verifi™ platform. This platform utilizes massively
parallel sequencing technology to screen for trisomies 13, 18, 21
and sex chromosome abnormalities, with the option to screen for 5
microdeletions including 22q11.2 (DiGeorge syndrome).
ClariTest™ can be performed as early as 10 weeks of gestational
age, can be performed in twin and egg donor pregnancies, has
excellent sensitivity and specificity, and has the lowest failure
rate in the industry.
Illumina’s most recent clinical evidence study of Verifi™ was
comprised of more than 85,000 clinical samples and demonstrated
observed sensitivity and specificity of trisomy 21 at greater than
99%. Trisomy 18 and trisomy 13 had observed sensitivity at
greater than 97% and specificity at greater than 99%. With the
industry’s lowest failure rate at 0.1%, Illumina’s Verifi™ service
can reduce maternal anxiety by requiring fewer redraws and reliably
providing fetal genetic information to a greater number of patients
and providers.
GenPath Women’s Health will ultimately develop and validate its
own laboratory-developed test for NIPT using Illumina’s sequencing
technology. Adoption of Illumina’s Verifi™ test allows GenPath to
continue to serve the NIPT market using the immense power of whole
genome sequencing while developing its own NIPT offering.
“We believe the best way to improve patient care is to unlock
the power of whole genome sequencing. We are pleased to partner
with BioReference and GenPath Women’s Health to expand the use
of Illumina technology for women’s health. The partnership
further extends Illumina’s strategy to enable a broader number of
customers to offer NIPT on our sequencing technology,” said Jeff
Hawkins, Vice President and General Manager of Reproductive Genetic
Health at Illumina.
“NIPT testing has become an incredibly valuable addition to
prenatal care and we are pleased to offer what we believe to be the
most technically advanced NIPT test available on the market.
ClariTest is a safe option to help pregnant women and their
physicians screen patients who are at an increased risk of a fetal
chromosome abnormality,” said Gregory S. Henderson, M.D., Ph.D.,
President of BioReference Laboratories. “Patient care is foremost
at BioReference and ClariTest provides highly accurate results at
an early gestational age. ClariTest is based on the latest
advances in technology, offering superior detection rates compared
to conventional screening methods for fetal chromosome
abnormalities and can significantly reduce the need for invasive
testing, which is associated with an increased risk for adverse
pregnancy outcomes, including pregnancy loss.”
ClariTest is available from GenPath Women’s Health. As a
convenience to patients and physicians alike, the laboratory
provides easy-to-read results reports available within 5-7 days
after testing, access to an industry-leading team of genetic
counselors, contracts with most national insurance carriers,
direct-to-patient pricing as part of the Community Health Advocacy
Program, the ability to interface with most EMR/EHRs, a
comprehensive network of patient service centers and other
ancillary support services.
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 launched
by partner TESARO and IV formulation pending FDA approval), TT401,
a once- or twice-weekly oxyntomodulin for type 2 diabetes and
obesity which is a clinically advanced drug candidate among the new
class of GLP-1 glucagon receptor dual agonists (phase 2), and
TT701, an androgen receptor modulator for androgen deficiency
indications (phase 2). 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 production and distribution
assets worldwide, multiple strategic investments and an active
business development strategy. More information is available at
www.opko.com.
About GenPath Women’s Health: GenPath Women’s
Health and its parent company BioReference Laboratories Inc. are
members of the OPKO Health, Inc. (NASDAQ:OPK) group of companies.
GenPath Women’s Health is a full-service laboratory offering a
complete menu of tests for the OB-GYN and women’s health providers.
Since its inception in 2005, GenPath Women’s Health has risen to
become one of the premier specialty labs in the country, including
the development of an innovative technology platform for sexually
transmitted and other vaginal infections, pan-ethnic carrier
testing and maternal risk assessment and prenatal diagnosis.
GenPath has grown and evolved to become the One Lab for every phase
of a patient’s life, offering solutions to all women’s health
testing and service needs. In 2015, GenPath launched an
industry-leading line of hereditary cancer testing. More
information is available at
http://www.genpathdiagnostics.com/womens-health/.
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 ClariTest and the performance of the test,
whether it will reliably provide fetal genetic information, whether
it offers superior detection rates and will significantly reduce
the need for invasive testing, 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.
Contacts:
OPKO Health, Inc.David Malina, 305-575-4137
GenPath Women’s HealthKesha Walker, 201-791-2600 x8651
MediaRooney PartnersTerry Rooney,
212-223-0689trooney@rooneyco.comorMarion Janic,
212-223-4017mjanic@rooneyco.com
InvestorsLHAAnne Marie Fields, 212-838-3777afields@lhai.com
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