Opko Health Inc (OPK)

[Traderbytrade]

OPKO Health, Inc. (NYSE:OPK) (“OPKO” or the “Company”) announces that Novitas Solutions has issued a draft local coverage determination for the 4Kscore® Test, the only blood test that accurately identifies an individual patient's risk for high-grade, aggressive prostate cancer. Novitas Solutions is a Medicare Administrative Contractor (MAC) for Medicare jurisdictions L and H, with responsibility for nearly 10 million Medicare beneficiaries in New Jersey, Pennsylvania, Maryland, the District of Columbia and Texas, among other geographies.

The draft local coverage determination is posted to the Medicare Coverage Database on the Centers for Medicare & Medicaid Services (CMS) website, and proposes to establish reimbursement coverage for patients with PSA levels >3 ng/mL who have not yet had a biopsy, or patients with a PSA level of >3 ng/mL who have had at least one prior negative biopsy and are considered to be at higher risk.

"This first MAC determination is a major milestone for the 4Kscore Test as it expands access to a potentially life-saving tool," said Phillip Frost, M.D., OPKO's Chairman and Chief Executive Officer. "We believe this decision by Novitas will help accelerate further coverage decisions by other payers, and will encourage adoption of the 4Kscore Test by physicians and patients. More importantly, it will allow broader access to this important test, which can assist patients and physicians in further defining a patient’s risk of having a high-grade prostate cancer that requires immediate or aggressive treatment.”

The draft local coverage determination follows the 4Kscore’s inclusion as a standard-of-care in the 2015 National Comprehensive Cancer Network Guidelines and in the 2016 European Association of Urology Prostate Cancer Guidelines for Prostate Cancer.

About the 4Kscore Test

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 National Comprehensive Cancer Network’s 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 physician and the patient.