OPKO Launches the 4Kscore Test in Europe
September 15 2014 - 09:13AM
Business Wire
OPKO Health, Inc. (NYSE:OPK) today announced the European launch
of the 4Kscore ™ Test, the only blood test that accurately
identifies risk for aggressive prostate cancer, through its wholly
owned subsidiary, OPKO Health Spain. The launch in Europe follows
the U.S. launch of the 4Kscore earlier this year.
The 4Kscore is a blood test that provides a patient his
individualized risk for aggressive prostate cancer. The panel of
biomarkers utilized in the 4Kscore is based on over a decade of
clinical research conducted in Europe by investigators from
Memorial Sloan-Kettering Cancer Center and leading European medical
institutions involving over 10,000 patients. The 4Kscore Test was
developed and validated by OPKO Lab in a 1,012 patient blinded,
prospective study in the U.S. in 2014. “We are proud to now offer
the 4Kscore Test to European clinicians and patients,” said Julián
Agut Sánchez, CEO of OPKO Health Europe. “The 4Kscore will bring
exceptional value to European healthcare by allowing clinicians to
accurately identify risk for aggressive prostate cancer. In
addition, there is great benefit for the patients and the
healthcare systems in avoiding the cost of unnecessary, sometimes
harmful procedures.”
The European launch of the 4Kscore Test is being done in
partnership with Barnaclínic, a branch of Hospital Clínic de
Barcelona, one of the most modern and largest clinical laboratories
in Europe. “The 4Kscore Test represents the new direction we must
follow in clinical medicine by combining multiple biomarkers for
greater diagnostic accuracy and delivering the results to the
clinician in an easy to interpret report,” said Aurea Mira Vallet,
Manager of the Diagnostic Biomedical Center, Hospital Clínic de
Barcelona. “We look forward to our partnership with OPKO on the
4Kscore Test and helping European Urologists to more accurately
identify risk for aggressive prostate cancer.”
Prostate cancer is the most common cancer in Europe for males
with over 400,000 new cases diagnosed in 2012. However, most of
these cancers are indolent cancers and are not likely to be life
threatening to the patient. “By accurately identifying risk for the
aggressive form of prostate cancer, the 4Kscore Test can make a
significant contribution in Europe to help target the right
patients for aggressive treatment and avoid the harms that
accompany over detection and over treatment of indolent prostate
cancer,” said David Okrongly, President of OPKO Diagnostics. “We
look forward to the growth in use of the 4Kscore in the U.S. and
Europe, and plan to launch the test in Latin America in the coming
months.”
About Prostate Cancer
According to the World Health Organization, prostate cancer is
the second most common cancer in men worldwide, with over 1.1
million men diagnosed with prostate cancer in 2012 and over 300,000
men dying from their disease. In countries like the U.S. where
screening for prostate cancer with the PSA test began 20 years ago,
there has been a sharp decline in prostate cancer mortality and
sharp rise in the incidence of prostate cancers detected. However,
most of the prostate cancers that are now detected are an indolent,
non-life threatening form of the disease. The net result has been
over detection and over treatment of indolent prostate cancers and
a rise in the complications from prostate cancer treatment such as
infection, erectile dysfunction, urinary obstruction and
incontinence.
About the 4Kscore Test
The 4Kscore is the only blood test that accurately identifies
risk for aggressive prostate cancer. The 4Kscore measures the blood
plasma levels of four different prostate-derived kallikrein
proteins: Total PSA, Free PSA, Intact PSA and Human Kallikrein 2
(hK2). These biomarkers are combined with a patient's age, Digital
Rectal Exam (DRE) status (nodule / no nodule), and prior negative
biopsy status (yes / no) using a proprietary algorithm to calculate
the risk (probability) of finding a Gleason Score 7 or higher
prostate cancer. The four kallikrein panel of biomarkers utilized
in the 4Kscore Test is based on over a decade of research conducted
by scientists at Memorial Sloan-Kettering Cancer Center and leading
European institutions. The 4Kscore Test provides individualized
risk for the presence of aggressive prostate cancer and adds new
information to the shared decision making discussion between a
Urologist and patient.
About OPKO Health
OPKO is a multinational biopharmaceutical and diagnostics
company that seeks to establish industry leading positions in
large, rapidly growing markets by leveraging its discovery,
development and commercialization expertise and novel and
proprietary technologies. For more information, visit
http://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 4Kscore Test, that the 4Kscore will
accurately identify risk for aggressive prostate cancer, whether
the test will bring exceptional value to European healthcare by
allowing clinicians to accurately identify risk for aggressive
prostate cancer, whether the test will bring great benefit to
patients and the healthcare system by helping avoid the cost of
unnecessary, sometimes harmful procedures, whether the 4KscoreTest
can make a significant contribution in Europe to help target the
right patients for aggressive treatment and avoid the harms that
accompany over detection and over treatment of indolent prostate
cancer, expected growth in use of the test in the U.S. and Europe
and whether OPKO will launch the test in Latin America, whether the
test will accurately predict high-grade cancers, whether OPKO will
successfully commercialize the 4Kscore, the market for and expected
sales of 4Kscore, whether the test will be an important benefit for
Urologists and their patients and will lead to lower overall
healthcare costs, 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.
OPKO Health, Inc.David Okrongly, 305-575-4133
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