Patients

The 4Kscore® Test Provides Information About Your Risk of Aggressive Prostate Cancer

The 4Kscore® Test

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 risk of aggressive prostate cancer using four prostate-specific biomarkers and your clinical information.

The 4Kscore® result assesses your risk of finding high-grade 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.

 

Novitas Issues Final Local Coverage Determination for the 4Kscore® Test   

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Understanding Your 4Kscore® Test Result

The 4Kscore® Test result provides you and your physician with your risk of high-grade, aggressive prostate cancer (Gleason 7 or higher) if a prostate biopsy were to be performed. The test has been validated in multiple US 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® result and overall clinical history.

NOTE: Biotin supplementation (>5 mg/day) may cause interference with assays that are components of the 4Kscore® Test and may lead to a falsely lower result.  Please abstain from taking biotin supplements for 7-10 days prior to having your blood drawn.

Low Risk

Based on your overall evaluation, your physician may wish to continue monitoring you.

Elevated Risk

Your physician will evaluate your 4Kscore® result, along with your clinical information, and discuss available options for next steps.

Find a Physician or 4Kscore® Draw Center

The 4Kscore® Test is a simple blood test that requires a blood sample, drawn at your physician's office or at a conveniently located 4Kscore® collection center. The 4Kscore® requires a test order form from your physician. Talk to your physician today to find out if the 4Kscore® Test is right for you.

Find a Physician

Physicians nationwide can order the 4Kscore® Test. Speak to your physician to find out if 4Kscore® is right for you or find a physician in your area through our physician locator.

Find a Physician Now

Find a 4Kscore® Draw Center

If your physician does not have the ability to draw a blood sample in the office, you can visit a 4Kscore® draw center in your area. The 4Kscore® requires a test order form from your physician. 

Find a 4Kscore Draw Center

Making a Shared Decision

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
The appropriate management for you depends on your medical history, clinical findings, and preferences after discussing several options with your physician. Shared decision making helps you and your loved ones make informed decisions.

LEARN MORE
This is a guide for screening and evaluation of aggressive prostate cancer and is not all inclusive of the risks, benefits, or complications for procedures and tests described.  Please review this decision aid with your physician to determine the next steps in your care.

 Download Our Guide

Patient FAQ

The 4Kscore® Test result provides you and your physician with your risk of high-grade, aggressive prostate cancer (Gleason 7 or higher) if a prostate biopsy were to be performed. The test has been validated in multiple US and European studies in over 20,000 men. Evaluation of test result and management decisions should be made in consultation with your physician, based on your 4Kscore® result and overall clinical history.

The 4Kscore® Test result assesses your risk of finding high-grade prostate cancer if a biopsy were performed and has been shown to categorize long-term risk of metastasis or dying from prostate cancer. With this information, you and your physician can make better-informed health care decisions.

4Kscore® measures four prostate-specific biomarkers (Total PSA, Free PSA, Intact PSA, 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 your risk for aggressive prostate cancer.

The 4Kscore® Test does not diagnose prostate cancer. It assesses your risk for aggressive prostate cancer after an abnormal screening result, to assist in the biopsy decision.

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 included in current US, Canadian, and European prostate cancer early detection guidelines.

4Kscore® was validated in two large independent US based prospective studies, including a 2017 study performed at Veterans Health Administration facilities involving predominantly 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 US.

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.  

Physicians nationwide can order the 4Kscore® Test, and many who are already using 4Kscore® are listed in our 4Kscore® physician locator. 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).

4Kscore® is covered by most leading health care 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 special 4Kscore® 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 health care 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 two comprehensive diagnostics divisions: BioReference Laboratories, Inc. and GeneDx, 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 http://www.opko.com        

 

GenPath Urology

GenPath Urology, provides comprehensive testing services to help monitor and evaluate urologic health, including:

  • Prostate Health: Find out why monitoring your prostate health is so important, information on various conditions that may affect your prostate, and how to get tested for them.
  • Bladder Health: Get to know more about common conditions that may require a visit to a urologist, including interstitial cystitis, urinary tract infection, and bladder cancer.
  • Kidney Health: Learn about two common kidney conditions, kidney stones and kidney cancer, and find out how GenPath can help to see if you might be at risk.
  • Sexually Transmitted Infections: Without knowing, you may be at risk for developing complications or could pass an infection to a current or future partner, so it’s important to get tested.
  • Hereditary Cancer: Certain cancers, such as prostate cancer or renal cancer, may run in your family. GenPath provides the testing and access to genetic counseling, so you can understand your risk.

References

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