Early detection of prostate cancer often begins with a PSA (Prostate Specific Antigen) test. While PSA is an effective initial prostate screening test, the result can be abnormal in a variety of benign (non-cancerous) conditions as well as in prostate cancer and lacks the specificity to distinguish between aggressive, potentially lethal prostate cancer and less serious cancer forms. As a result, many men are subjected to invasive procedures, including prostate biopsies, that could be avoided. Approximately 25% of biopsies performed after an abnormal PSA screening test detect aggressive prostate cancer. The majority of prostate biopsies find either no cancer or detect the low-grade, slow-growing forms of prostate cancer.1
The 4Kscore® Test is a follow-up blood test after an abnormal PSA and/or digital rectal exam (DRE) to assess your probability of finding aggressive prostate cancer, using four prostate-specific biomarkers and your clinical information.
The 4Kscore® Test result assesses your probability of aggressive prostate cancer if a biopsy were performed and has been shown to categorize long-term risk of cancer metastasis or of dying from prostate cancer.
For information on diagnostic testing options for the male reproductive system offered through GenPath Urology, read more below.
The 4Kscore® Test result provides you and your physician with your probability of finding of high-grade, aggressive prostate cancer (Gleason 7 or higher) if a prostate biopsy were to be performed. The 4Kscore® Test is FDA approved and has been validated in multiple U.S. and European studies in over 20,000 men. Evaluation of test results and management decisions should be made in consultation with your physician, based on your 4Kscore® Test result and overall clinical history.
NOTE:Biotin concentrations up to 25 ng/mL in serum demonstrate a less than or equal to 10% change in measurement of The 4Kscore® Test. Biotin concentrations greater than this may change The 4Kscore Test results for patient samples. Patients taking supplements containing biotin should discontinue usage for at least 3 days prior to 4Kscore testing.
A 4Kscore® <5.0 is associated with decreased likelihood of a Gleason score ≥7 on biopsy.
Your physician will evaluate your 4Kscore® result, along with your clinical information, and discuss options for next steps.
The 4Kscore® Test is a simple blood test and requires a test order from your physician. The blood can be drawn at your physician's office, at a conveniently located Patient Service Center, or at your home or office using Scarlet. Talk to your physician today to find out if The 4Kscore® Test is right for you.
Physicians nationwide can order The 4Kscore® Test. Speak to your physician to find out if The 4Kscore® Test is right for you.
DISCUSS PROSTATE CANCER
Screening for prostate cancer is an individual decision for you to discuss with your physician. 1 in 9 men will be diagnosed with prostate cancer in their lifetime.2
MAKING A SHARED DECISION
Shared decision-making helps you and your loved ones make informed decisions. Discussing your medical history, clinical findings, and preferences with your physician will help you make a decision that is right for you.
This is a guide for screening and evaluation of aggressive prostate cancer and is not all inclusive of the probabilities, benefits, or complications for procedures and tests described. Please review this decision aid with your physician to determine the next steps in your care.
The 4Kscore® Test is an FDA approved follow-up blood test after an abnormal PSA and/or digital rectal exam (DRE) to assess the probability of finding aggressive prostate cancer if you were to have a prostate biopsy.
The 4Kscore® Test is FDA approved and has been validated in multiple U.S. and European studies in over 20,000 men. Disease management decisions should be made in consultation with your physician, based on your 4Kscore® Test result and overall clinical history.
The 4Kscore® Test result provides you and your physician with the probability of finding high-grade, aggressive prostate cancer (Gleason 7 or higher) if a prostate biopsy were to be performed and has been shown to categorize long-term probability of metastasis or death from prostate cancer. With this information, you and your physician can make better-informed healthcare decisions.
The 4Kscore® Test measures four prostate-specific biomarkers (Total PSA, Free PSA, Intact PSA, and human kallikrein 2 [hK2]), along with your clinical information (patient age, prior biopsy history, digital rectal exam result [optional]) using a complex algorithm to assess the probability of finding aggressive prostate cancer if you were to have a prostate biopsy.
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 the probability of finding aggressive prostate cancer if you were to have a biopsy.
Yes. The four kallikrein biomarkers utilized in The 4Kscore® Test have been researched for over a decade by scientists at leading international cancer research centers. The accuracy and reliability of The 4Kscore® Test has been shown in clinical trials involving more than 20,000 men. The 4Kscore® Test is approved by the FDA and included in current U.S., Canadian, and European prostate cancer early-detection guidelines.
The 4Kscore® Test was validated in two large independent U.S.–based prospective studies, including a 2017 study performed at eight Veterans Health Administration facilities involving a majority of African American men. Over a dozen peer-reviewed articles have been published in leading medical journals on the clinical effectiveness of the 4Kscore® Test, and more than 200,000 4Kscore® Tests have been performed in the U.S.
Your physician should receive your 4Kscore® Test result within 2 to 3 working days from the time our laboratory receives your blood sample. Your physician will contact you to discuss your 4Kscore® Test result and options for next steps regarding your prostate health.
Physicians nationwide can order The 4Kscore® Test. Contact your physician for more information about The 4Kscore® Test.
If you would like assistance in contacting a physician, please contact Customer Service at 1-833-4Kscore (1-833-457-2673).
The 4Kscore® Test is covered by most leading healthcare insurance plans. We will bill a patient's insurance company, and the patient will only be responsible for applicable copayment, co-insurance, and/or deductible amounts. For non-covered services, BioReference Laboratories, Inc. and our GenPath division also have self-pay and payment plan options available.
If you have any questions or concerns, please call our 4Kscore® Test Customer Service Hotline at 855-4KBILLING (855-452-4554), 9 am – 9 pm EST Monday-Friday.
If you are looking to pay an invoice from BioReference Laboratories, Inc. or our GenPath division, please proceed to our online payment portal where you will be able to use your credit card to pay your bill for the test you received easily and securely.Pay Bill*
*By clicking this link, you will be taken to an external page for the BioReference payment portal. Should you have any other questions about your bill or insurance, please call: 1-855-4KBILLING (1-855-452-4554).
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 the comprehensive diagnostics division 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
GenPath Urology, provides comprehensive testing services to help monitor and evaluate urologic health, including:
1. Oregon Health & Science University. "Presence Of High-risk Prostate Cancer Can Be Predicted Without A Biopsy, New Study Says." ScienceDaily, 22 May 2005.
2. American Cancer Society. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html