Study Demonstrates OPKO’s 4Kscore Test Reduces Unnecessary Prostate Biopsies While Improving Risk Prediction for Aggressive...
February 09 2016 - 8:30AM
Business Wire
4Kscore Test Results Significantly Influenced
Physician-Patient Shared Decision-Making in Clinical Practice and
Led to a 64.6% Reduction in Prostate Biopsies
OPKO Health, Inc. (NYSE: OPK) announced today the results of a
study for the 4Kscore® Test’s clinical utility in reducing the
number of prostate biopsies performed, while increasing the
probability of detecting aggressive prostate cancer in men with
abnormal prostate-specific antigen (PSA) levels and or digital
rectal examination (DRE) results. The peer-reviewed study, “The
4Kscore® Test Reduces Prostate Biopsy Rates in Community and
Academic Urology Practices”, written by Badrinath Konety, MD, et
al. and published in the January 2016 edition of Reviews in
Urology, a MedReviews, LLC. Publication, which included 611
patients seen by 35 academic and community urologists across the
United States, indicated that consideration of results from the
4Kscore tests led to 64.6% fewer prostate biopsies being performed
among participating patients.
“The 4Kscore test is a useful tool in identifying men with a
significant risk of having an aggressive form of prostate cancer,
who are most likely to benefit from a prostate biopsy and selective
treatment or intensive intervention, while avoiding biopsies in men
who are at low risk for developing aggressive disease,” commented
lead researcher Badrinath Konety, M.D., Dougherty Family Chair in
Uro-Oncology and director of the Institute for Prostate and
Urologic Cancers at the University of Minnesota. “Our findings
suggest that PSA screening, when coupled with the 4Kscore test, can
be made more specific, reduce biopsy complications and
overtreatment, and be a more cost-effective solution for managing a
patient’s prostate health.”
Dr. Konety and colleagues evaluated the influence of the 4Kscore
test on urologist-patient decisions about whether to perform a
biopsy in men who had an abnormal PSA and or DRE result. Test
results for patients were stratified into low risk (<7.5%),
intermediate risk (7.5%-19.9%) and high risk (≥20%) for developing
aggressive prostate cancer. Nearly half (49.3%) of the men were
categorized as low risk; 25.7% and 25.0% fell into the
intermediate-risk and high-risk categories, respectively. Notably,
the 4Kscore test results influenced biopsy decisions in 88.7% of
the men. In the three risk groups, a biopsy was avoided in 94.0%,
52.9%, and 19.0% of men in the low, intermediate, and high-risk
categories, respectively.
A higher 4Kscore test result was significantly associated with a
greater likelihood of having a prostate biopsy (P< 0.001). Among
the 171 men who had a biopsy, 45 of the 104 cases (43.3%) with a
high-risk 4Kscore test result (≥20% risk) were found to have
aggressive prostate cancer upon prostate biopsy.
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 test 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, and other
clinical information 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 included as a 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, Inc.
OPKO Health, Inc. is a diversified healthcare company that
seeks to establish industry-leading positions in large, rapidly
growing markets. Our diagnostics business
includes Bio-Reference Laboratories, the nation's
third-largest clinical laboratory with a core genetic testing
business and a 420-person sales force 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™, a treatment for secondary
hyperparathyroidism (SHPT) in stage 3-4 chronic kidney disease
(CKD) patients with vitamin D insufficiency (March 29,
2016 PDUFA date) and VARUBI™ for chemotherapy-induced nausea
and vomiting (oral formulation launched by partner Tesaro, IV
formulation in Phase 3). 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 (entering 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.
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 biopsies by 64.6%, reduce overtreatment and provide a cost
effective solution for managing prostate health, 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.
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OPKO Health, Inc.Tara Mackay, 305-575-4100Investor
RelationsorMediaRooney & AssociatesTerry Rooney,
212-223-0689trooney@rooneyco.comorMarion Janic,
212-223-4017mjanic@rooneyco.comorInvestorsLHAAnne Marie
Fields, 212-838-3777afields@lhai.comorBruce Voss,
310-691-7100bvoss@lhai.com
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