January 28, 2015 1:21pm EST
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MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK) today announced the launch of the 4Kscore®
test, the only blood test that accurately identifies risk for aggressive
prostate cancer, in Mexico through its wholly owned subsidiary, OPKO
Health Mexico. The launch in Mexico follows the U.S. and European launch
of the 4Kscore test in 2014.
The 4Kscore provides a patient with his own individualized risk for
aggressive prostate cancer. The test was developed and validated by OPKO
in a 1,012 patient blinded, prospective study in the United States in
2014. The results of this validation trial were published in the journal European
Urology and presented at the 2014 Congress of the Mexican Society of
Urology by one of the publication’s authors, Dr. Sanoj Punnen, of the
University of Miami.
“We are pleased to now be able to offer the 4Kscore test to the
clinicians and patients of Mexico,” said Joaquin Peniche, CEO of OPKO
Health Mexico. “The plenary presentation on the 4Kscore was well
received by Urologists attending the Congress of the Mexican Society of
Urology in Guadalajara, Mexico this past November and we now look
forward to offering the product into the Mexican market.”
In Mexico, prostate cancer is the most common cause of cancer death in
males with 5,911 deaths recorded in 2012.
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 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 value to Mexican
healthcare by allowing clinicians to accurately identify risk for
aggressive prostate cancer, whether the test will benefit patients and
the healthcare system by helping avoid the cost of unnecessary,
sometimes harmful procedures, whether the 4KscoreTest can 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., Mexico and Europe and
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
Source: OPKO Health, Inc.
Released January 28, 2015
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