November 04, 2013 8:51am EST
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MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE: OPK) has commenced a pivotal, multi-center
clinical validation study for the Company’s proprietary 4Kscore™ test
for the prediction of prostate cancer prior to prostate biopsy. The
4Kscore™ test is based on over a decade of research of a four kallikrein
panel of biomarkers conducted by scientists at Memorial Sloan Kettering
Cancer Center and leading research centers in Europe on over 10,000
patients. The OPKO multi-center study is expected to generate data to
support the launch of the 4Kscore™ test as a laboratory developed test
through the Company’s CLIA laboratory in Nashville, TN. The Company has
begun enrolling patients at the first of 13 sites across the United
States and is planning to enroll more than 1,200 patients referred for a
prostate biopsy over the course of the next few months.
“The OPKO Lab 4Kscore™ test is expected to be an important tool in the
fight against prostate cancer and the prevention of unnecessary
biopsies,” said Dr. Peter Scardino, Chair, Department of Surgery,
Memorial Sloan Kettering Cancer Center. “We are optimistic that the
newly initiated clinical study will prospectively demonstrate for
U.S.-based clinicians and payers the value of the 4Kscore™ test as an
important guide in managing patients.”
According to a paper titled “The Kallikrein Panel for Prostate Cancer
Screening: Its Economic Impact”, published online October 26, 2013 in
the journal The Prostate, it is estimated that about $1 billion in
healthcare costs could be saved annually in the U.S. by implementing a
four kallikrein panel test and using the results of the test to
determine if a prostate biopsy should be performed.
“We believe OPKO’s 4Kscore™ test will address a significant unmet
medical need for better tests to identify men at risk for aggressive
prostate cancer, while at the same time avoiding unnecessary, costly,
and potentially harmful treatments,” said Phillip Frost, M.D., OPKO's
Chairman and Chief Executive Officer.
“Our clinical study with over 15 of the leading and largest urology
centers across the United States is the last step before our commercial
launch of the 4Kscore™ in the first quarter of 2014. The data we
generate in this clinical study will not only be used for the required
CLIA validation, but will also provide important data for securing
4Kscore™ reimbursement,” stated David Okrongly, Ph.D., President of OPKO
Diagnostics.
About the 4Kscore™ Test
The 4Kscore™ is a convenient blood test that measures the serum levels
of four different prostate-derived kallikrein proteins: total PSA, free
PSA, intact PSA and hK2. Levels of these biomarkers are combined with a
patient’s age and digital rectal exam (DRE) status using a proprietary
algorithm to calculate the probability of a finding of aggressive
prostate cancer. The information provided by the 4Kscore™ test can help
facilitate the shared decision-making process between urologist and
patient in determining the advisability of a prostate biopsy.
About Prostate Cancer
In 2013, over 238,000 new cases of prostate cancer will be identified
and 29,720 men will die from the disease, according to estimates
released by the National Cancer Institute, making it the second most
deadly cancer in U.S. men. Prostate cancer is usually first detected by
elevations in serum PSA. However, PSA level is often high for reasons
unrelated to prostate cancer and, since an elevated PSA level often
leads to biopsy, 75% of all prostate biopsies performed are either
negative or indicate a low likelihood of aggressive cancer.
About OPKO Health, Inc.
OPKO is a multi-national biopharmaceutical and diagnostics company that
seeks to establish industry-leading positions in large and rapidly
growing medical markets by leveraging our discovery, development and
commercialization expertise and our novel and proprietary technologies.
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™, whether OPKO’s multi-center study will generate data to
support CLIA validation and reimbursement, whether the 4Kscore™ will
be an important tool in the fight against prostate cancer and the
prevention of unnecessary biopsies, expectations regarding enrollment of
the study and the completion date for the study, whether OPKO will be
able to successfully launch and commercialize the 4Kscore™ and the
expected launch date for the 4Kscore™, the market for and expected sales
of 4Kscore™, whether the use of the 4Kscore™ could result in savings of
$1 billion in healthcare costs and address a significant unmet medical
need for better tests to identify men at risk for aggressive prostate
cancer, while at the same time avoiding unnecessary, costly, and
potentially harmful treatments, 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.
Steven D. Rubin or Juan F. Rodriguez, 305-575-4100
Source: OPKO Health, Inc.
Released November 4, 2013
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