February 09, 2016 8:30am EST
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4Kscore Test Results Significantly Influenced Physician-Patient
Shared Decision-Making in Clinical Practice and Led to a 64.6% Reduction
in Prostate Biopsies
MIAMI--(BUSINESS WIRE)--
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160209005602/en/
OPKO Health, Inc.
Tara Mackay, 305-575-4100
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Source: OPKO Health, Inc.
Released February 9, 2016
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