On OPKO Health, Inc. (NYSE:OPK) reported that the American Medical Association (AMA) Current Procedural Terminology (CPT) Editorial Panel has granted a Category I CPT code for its 4Kscore Test, the only blood test that accurately identifies an individual patient’s risk for aggressive prostate cancer (Press release, Opko Health, NOV 12, 2015, View Source [SID:1234508212]). This important event upgrades the 4Kscore Test from a Category III Administrative code to a Category I CPT code, a designation reserved for established diagnostic tests, and will provide broader access to the 4Kscore Test to urologists and their patients across the United States.

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"The CPT Category I approval is recognition by the leading panel of medical experts in the United States that the 4Kscore Test is now an established diagnostic test addressing an important unmet medical need," said David Okrongly, Ph.D., President of OPKO Diagnostics. "The multiple peer-reviewed clinical studies, inclusion of the 4Kscore Test in the 2015 National Comprehensive Cancer Network (NCCN) guidelines for Prostate Cancer Early Detection, and the growing adoption of the test in the United States were key factors in the decision by the CPT Editorial Board reviewers."

"This is a major milestone for the 4Kscore Test toward providing access to the 4Kscore Test for all eligible patients," said Phillip Frost, M.D., OPKO’s Chairman and Chief Executive Officer. "We believe it will help streamline claims processing and accelerate further coverage and adoption decisions by payers, physicians, and patients."

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, 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 Category I CPT Codes

In addition to facilitating reimbursement in government programs such as Medicare and Medicaid, CPT codes are used by other insurance companies and government payers to describe health care services and procedures. The AMA CPT Editorial Panel has established criteria for Category I designation of new diagnostic tests and the details are available on the AMA website. In summary, the Category I criteria include: performance of the test in an appropriately regulated laboratory environment, ordering of the test by many physicians and at a volume consistent with the intended clinical use, demonstration that the use of the test is consistent with current medical guidelines, and published scientific evidence of clinical efficacy.