Physicians

The 4Kscore® Test is a simple blood test that combines four prostate-specific biomarkers along with patient clinical information in a complex algorithm that determines the probability of aggressive prostate cancer if a biopsy were to be performed. The 4Kscore® Test allows patients and physicians to make better-informed decisions in determining if a prostate biopsy is needed.

The 4Kscore® Test result assesses the probability of finding high-grade prostate cancer if a biopsy were performed and has been shown to categorize long-term probability of prostate cancer metastasis and mortality. By specifically assessing the probability of finding aggressive prostate cancer after an abnormal PSA or DRE screening result, The 4Kscore® Test may help men to decide the appropriate next steps in their prostate healthcare.

The 4Kscore® Test measures the serum levels of four different prostate-derived kallikrein proteins: Total PSA, Free PSA, Intact PSA, and human kallikrein 2 (hK2). Levels of these biomarkers are combined with a patient’s age, prior biopsy status, and DRE, and processed using an FDA-approved algorithm to calculate a patient’s individualized probability of having high-grade, aggressive prostate cancer (Gleason score 7 or higher) if a prostate biopsy were performed.

The intended use population of The 4Kscore® Test are:
• Men 45-54 years old and total PSA ≥2 ng/mL and/or abnormal DRE
• Men 55-75 years old and total PSA ≥3 ng/mL and/or abnormal DRE
• Men ≥76 years old and total PSA ≥4 ng/mL and/or abnormal DRE

The 4Kscore® Test does not diagnose prostate cancer. It is used after an abnormal PSA or DRE screening test to assist in the biopsy decision. The 4Kscore® Test assesses a patient’s probability of having aggressive prostate cancer if he were to have a biopsy.

The 4Kscore® Test algorithm is FDA approved and has been researched extensively by scientists at leading international cancer research centers. The accuracy and reliability of The 4Kscore® Test have been shown in clinical trials involving more than 20,000 men.

• The 4Kscore® Test is indicated for use with other patient information as an aid in the decision for prostate biopsy in men 45 years of age and older who have an abnormal age-specific total PSA and/or abnormal DRE. The 4Kscore® Test is intended to aid in detection of aggressive prostate cancer (Gleason score ≥7/Gleason Grade Group ≥2) in those for whom a biopsy would be recommended by a urologist, based on current standards of care before consideration of The 4Kscore® Test
• A 4Kscore® <5.0 is associated with decreased likelihood of a Gleason score ≥7 on biopsy. Prostate biopsy is required for the diagnosis of cancer. The test is not recommended more than once every 6 months
• The 4Kscore® Test was validated in two large independent U.S.–based prospective studies
  • When the probability score of 7.5% was used for assessment, no Gleason scores >8 were missed
  • One validation study was completed in 2017 and performed at Veterans Health Administration facilities involving a predominantly African American population
• Over a dozen peer-reviewed studies on the clinical effectiveness of The 4Kscore® Test have been published
• Over 200,000 4Kscore® Tests have been performed in the U.S.
• Research has demonstrated that The 4Kscore® Test can probability-stratify men for prostate cancer metastasis and mortality for up to 20 years

The 4Kscore® Test result provides the probability of finding aggressive prostate cancer (Gleason 7 or higher) if a prostate biopsy were performed. Patients with an elevated 4Kscore® result should be considered for further evaluation and treatment.

The 4Kscore® Test result should be interpreted in conjunction with other patient-specific information to develop a personal patient management plan.

The 4Kscore® Test is not indicated in men with:

• Previous diagnosis of prostate cancer
• DRE performed in the previous 96 hours before phlebotomy
• 5-alpha reductase medication within previous 6 months
• Prostate procedure within the last 6 months

The 4Kscore® Test result is usually provided within 2 to 3 working days of receiving a completed requisition and patient sample. For turnaround time on other tests, please contact our Customer Service team at 1-800-627-1479.

The 4Kscore® Test result can be received in the manner most compatible for the physician’s needs. Results can be reported through:

• Courier delivery
• Office fax
• Online reporting through InsightDx
• Direct interfacing into Electronic Medical Records (EMR)

There is also an easy-to-understand patient report that physicians can use to explain The 4Kscore® Test results to patients.

When you are better able to navigate test results and can effortlessly sort through complex sets of patient data, you are free to focus on providing excellent patient care.

Our bio-portal adds value to your EMR investment. It provides an internet-based order entry and results reporting solution for laboratory, pathology, and radiology outreach businesses. Its EMR and EHR connectivity solutions can deliver results to and accept orders from virtually every electronic medical record system in the market today, and more than 30,000 physicians use our system daily for Computerized Physician Order Entry (CPOE) and clinical results review.

Contact your local sales representative for additional details and information.

Yes, physicians nationwide can order The 4Kscore® Test. It is performed using a patient’s blood sample drawn at the physician’s office, a conveniently located 4Kscore® Test blood draw facility, or a patient’s home or office using Scarlet. The test is performed by BioReference Laboratories, Inc. and results are sent back to the ordering physician.

The 4Kscore® Test is performed by BioReference Laboratories, Inc. (a wholly owned subsidiary of OPKO Health, Inc.), a CLIA-certified and CAP-accredited laboratory.

If you are interested in adding The 4Kscore® Test to your diagnostic offering, please contact us to request a visit to your office by one of our sales representatives to discuss your service needs. Your dedicated sales representative will also be pleased to provide you with:

• An overview of our general diagnostic and urology offerings
• Arrangements for a customized laboratory program
• Monthly “Clinical Updates” newsletters

Please contact us at 833-4Kscore (833-457-2673) or by email at 4kcustomerservice@bioreference.com
to request a visit to your office by one of our sales representatives to discuss your service needs.

The 4Kscore® Test helps you optimize your treatment workflow so that high-probability patients get the diagnosis and treatment they need while reducing prostate biopsies in men not likely to have aggressive prostate cancer.

BioReference Laboratories, Inc. has contracts with all national carriers and hundreds of regional carriers to simplify billing and minimize out-of-network billing issues. To provide better service, our laboratory helps patients with any insurance questions and makes appeals on patients’ behalf.

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The invoice a patient receives is for laboratory services provided by BioReference, which were ordered by a physician. This invoice is for laboratory testing fees only and is separate from any bill they may have received from the physician and/or paid at the physician’s office. The bill typically includes charges for deductibles, insurance co-payments, or those services not covered by the insurance provider. Please review the insurance policy for more information about specific coverage. If it appears that a patient does not have insurance coverage, or if the information provided to BioReference was incomplete or inaccurate, we will request that the patient provide additional information. We will gladly resubmit any claim to the insurer once we have the new information. Because we work through the patient’s insurance provider in this way, it may take several months after the date of service before a patient receives our bill.

Each time we bill an insurer for laboratory services provided on behalf of the patient or a covered dependent, the insurer will send the patient an Explanation of Benefits. The Explanation of Benefits explains how much the insurer will pay, along with an estimate of the patient’s financial responsibility. Since the Explanation of Benefits is not a bill, the patient should only pay BioReference when they receive a bill directly from us.

If a patient has any questions or concerns, please call our special 4Kscore® Customer Service Hotline at 855-4KBILLING (855-452-4554), 9 am – 9 pm EST Monday-Friday. The BioReference Billing Department can also be reached at 1-800-229-5227, option 2, 8 am – 9 pm EST, Monday through Friday.

OPKO Health, Inc. is a diverse healthcare company with the flexibility to adapt to evolving patient needs. OPKO Health, Inc. offers first-in-class products such as Rayaldee® and The 4Kscore® Test, as well as BioReference Laboratories, Inc. In addition to clinical products and diagnostics, OPKO Health, Inc. also features a robust research and development pipeline and a variety of biomedical and pharmaceutical business solutions.

For more information, visit https://www.opko.com