June 26, 2015 10:25am EDT
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MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK) today announced the decision of the
National Comprehensive Cancer Network (NCCN) to include 4Kscore® as a
recommended test in the 2015 NCCN Guidelines for Prostate Cancer Early
Detection. The panel concluded that the 4Kscore, as a blood test with
greater specificity over the PSA test, is indicated for use prior to a
first prostate biopsy or after a negative biopsy to assist patients and
physicians in further defining the probability of high-grade cancer.
“We are pleased that the NCCN, an organization leading the way in the
establishment of evidence-based guidelines for cancer diagnostics, is
recommending the use of the 4Kscore test in the 2015 Prostate Cancer
Early Detection Guidelines,” said David Okrongly, Ph.D., President of
OPKO Diagnostics.
The 4Kscore test has been studied on over 22,000 patients with results
published in 12 peer-reviewed scientific publications. “Since its
launch, I have been offering and using the 4Kscore test with my patients
who have an abnormal PSA prior to a first prostate biopsy and before
repeating a prostate biopsy after a negative biopsy,” said Dr. Dipen
Parekh, Professor and Chair, Department of Urology at the University of
Miami and principal investigator for the recently published United
States multicenter validation study. “The 4Kscore provides me as a
clinician with important information about my patient’s individual risk
for having aggressive prostate cancer and allows me to have an informed
discussion with my patient about whether or not to proceed with a
prostate biopsy or safely follow the patient.”
The 4Kscore test is the only blood test that accurately identifies an
individual patient’s risk for high-grade, aggressive cancer. In arriving
at their recommendations, the NCCN panel stated: “The challenge is to
minimize immediate treatment (over-treatment) of indolent cancers by
accurately characterizing the biology of the detected cancer.
Identification and selective treatment of aggressive cancers should
result in significant decreases in morbidity and mortality while
limiting adverse effects on quality of life.”
“OPKO is committed to the strategy that effective therapy, particularly
cancer therapy, can be greatly enhanced by use of diagnostic tests,”
said Phillip Frost, M.D., OPKO's Chairman and Chief Executive Officer.
“Through diagnostics, we can enable physicians to take a more targeted
and precise approach in their treatment strategies and thus improve
patient outcomes and lower overall healthcare costs.”
About the 4Kscore Test
The 4Kscore is the only blood test that accurately identifies an
individual patient’s risk for aggressive prostate cancer, the lethal
form of prostate cancer. The 4Kscore uses a proprietary algorithm that
incorporates the blood levels of four different prostate-derived
kallikrein proteins: Total PSA, Free PSA, Intact PSA and Human
Kallikrein-2 (hK2), plus the patient's age, Digital Rectal Exam (DRE)
status (nodule / no nodule), and prior negative biopsy status (yes / no)
to calculate the percentage risk (probability) of finding a Gleason
Score 7 or higher grade of 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 and is established as a
recommended standard of care in the 2015 NCCN Prostate Cancer Early
Detection Guidelines. The 4Kscore Test provides individualized risk for
the presence of aggressive prostate cancer and adds new information to
the shared decision making discussion between the Urologist and the
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, the power of the 4Kscore to provide valuable information to
accurately identify aggressive prostate cancer and guide clinical
decision making, whether it will accurately predict high-grade
cancers, improve patient outcomes and reduce health care costs, whether
OPKO will successfully commercialize the 4Kscore, and the market for and
expected sales of 4Kscore, 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/20150626005490/en/
OPKO Health, Inc.
David Okrongly, 305-575-4133
Source: OPKO Health, Inc.
Released June 26, 2015
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