OPKO 4Kscore® Recommended in 2016 European Association of Urology Prostate Cancer Guidelines

MIAMI–(BUSINESS WIRE)– OPKO Health, Inc. (NYSE:OPK) today announced the decision of the European Association of Urology (EAU) Prostate Cancer Guidelines Panel to include the 4Kscore® Test in the 2016 EAU Guidelines for Prostate Cancer. 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.

“The EAU Prostate Cancer Guidelines Panel is an international, multi-disciplinary group of specialists in prostate cancer diagnosis and treatment,” said Dr. Alberto Briganti, Department of Urology, San Raffaele Scientific Institute, Milan, Italy. “The decision to include the 4Kscore in the guidelines indicates that the Panel views the 4Kscore Test as having achieved an appropriate level of clinical evidence to recommend its use for both assessment of asymptomatic men prior to a first prostate biopsy and as an additional investigational test to be done after a negative prostate biopsy.”

The 4Kscore test has been studied on over 22,000 patients with results published in 12 peer-reviewed scientific publications. The 4Kscore test is the only blood test that accurately identifies an individual patient’s risk for high-grade, aggressive cancer.

Acerca de la prueba 4Kscore

The 4Kscore, a laboratory developed test, 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 both the 2016 NCCN Early Detection Guidelines and the 2016 EAU Guidelines for prostate cancer. 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.

Acerca de OPKO Health

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 (29 de marzo de 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. Hay más información disponible en www.opko.com.

DECLARACIÓN DE PUERTO SEGURO

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, reduce overtreatment and provide a cost effective solution for managing prostate health, whether OPKO will successfully commercialize the 4Kscore in the U.S. and Europe, 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. Muchos factores podrían hacer que nuestras actividades o resultados reales difieran sustancialmente de las actividades y resultados anticipados en las declaraciones con perspectivas de futuro. Estos factores incluyen los descritos en nuestras presentaciones ante la Comisión de Bolsa y Valores, así como los riesgos inherentes a la financiación, el desarrollo y la obtención de aprobaciones regulatorias de productos y tratamientos nuevos, comercialmente viables y competitivos. Además, las declaraciones con perspectivas de futuro también pueden verse afectadas de manera adversa por factores generales del mercado, desarrollo de productos de la competencia, disponibilidad de productos, normas y leyes federales y estatales, el proceso regulatorio de nuevos productos e indicaciones, problemas de fabricación que puedan surgir, posiciones de patentes y litigios, entre otros factores. Las proyecciones que contiene este comunicado de prensa solo expresan la situación a la fecha en que se realizaron, y no asumimos obligación alguna de actualizar las proyecciones. Tenemos la intención de que todas las declaraciones con perspectivas de futuro estén sujetas a las disposiciones de puerto seguro de la ley PSLRA.

OPKO Health, Inc.
Tara Mackay, 305-575-4100
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Fuente: OPKO Health, Inc.

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