Frequently Asked Questions about the 4Kscore Test for Prostate Cancer

4Kscore Test for Prostate Cancer

The 4Kscore Test can help reduce the number of unnecessary biopsies, by measuring a man’s risk of having aggressive prostate cancer. If that risk is low, a patient may, in consultation with his Urologist or physician, decide not to have a prostate biopsy and avoid the associated pain and complications such as bleeding and infection that can result from the biopsy procedure. Also, by avoiding a diagnosis of a low-grade, non-life threatening form of prostate cancers (Gleason score = 6), the patient may avoid treatments that he may not need.

The 4Kscore test was developed by OPKO Health and is performed at its CLIA-accredited and CAP-Certified wholly-owned subsidiary laboratories, BioReference Laboratories and GenPath Diagnostics. It is a physician-ordered and physician-reported test. Since the release in March 2014 we have received many requests from potential patients and healthcare providers. We are actively providing healthcare providers with critical information on the 4Kscore Test so they can become providers of the test. If you are a patient currently under the care of a Urologist, we will assist your Urologist in learning more about the 4Kscore Test.

The 4Kscore Test is a blood test that measures the levels of four different prostate-derived proteins. The values of these protein levels and other medical information from your Urologist are used to calculate the chances of finding aggressive prostate cancer if a prostate biopsy were to be done.

The four prostate derived proteins or biomarkers, commonly called Kalikriens, are:

  • Total PSA
  • Free PSA
  • Intact PSA
  • Human Kallikrein 2 (hK2)

The 4Kscore Test can help reduce the number of unnecessary biopsies, by measuring a man’s risk of having aggressive prostate cancer. If that risk is low, a patient may, in consultation with his Urologist, decide not to have a prostate biopsy and avoid the associated pain and complications such as bleeding and infection that may result from the biopsy procedure. Also, by avoiding a diagnosis of a low-grade, non-life threatening form of prostate cancers (Gleason score = 6), the patient may avoid treatments that he may not need.

The 4Kscore Test would benefit any patient with concern about prostate cancer. The 4Kscore provides a patient with their risk or chance of having an aggressive form of prostate cancer that can help them avoid an unnecessary biopsy or provide information that can move them to diagnosis and effective treatment.

Common Reasons for a TRUS prostate biopsy:

  • Family history of prostate cancer
  • Elevated PSA or High PSA
  • Abnormal results from a digital rectal exam (DRE)
  • Prior negative biopsy

No, the 4Kscore Test does not provide a diagnosis of prostate cancer. It is a blood test that provides a patient with their risk of having an aggressive form of prostate cancer. The 4Kscore result, along with other clinical information, can form the basis of a discussion between you and your Urologist about the medically appropriate next step.

The biomarkers utilized in the 4Kscore Test is based on over a decade of research on 10,000 patients conducted by scientists at Memorial Sloan-Kettering Cancer Center and leading research centers in Europe. OPKO Health developed the 4Kscore Test, and validated the performance of the 4Kscore Test in a clinical trial on 1,012 men at 26 urology centers in the United States. The test is currently performed at BioReference Laboratories and GenPath Diagnostics, wholly-owned subsidiaries of OPKO Health.

BioReference Laboratories and GenPath Diagnostics, wholly-owned subsidiaries of OPKO Health, offer healthcare providers a single source for all their laboratory testing needs in both the primary and specialty health care segments.  BioReference Laboratories will bill a patient’s insurance company, and it typically takes 60 days for insurance companies to respond to claims.  At that time the insurance company may request additional information to process the claim.

The patient may receive an Explanation of Benefits (EOB) statement in the mail; It is important to note that this is not a bill. The purpose of an EOB is to explain what medical services were covered and what the patient’s financial responsibilities will be.  If any insurance company does not pay the filed claim because the company deems the test investigational, not a covered service or out-of-network, BioReference and GenPath will file an appeal on the patient’s behalf.  The patient will only be responsible for applicable copayment, coinsurance and/or deductible amounts.  For non-covered services, BioReference also has self-pay and payment plan options available.

If a patient has  any  questions  or  concerns,  please  call  our  special  4Kscore  Customer Service Hotline at 855-4KBILLING (855-452-4554) 9am-5pm EST Monday-Friday.

Yes. You may access the full list of publications by visiting the clinical validation page for Urologists.

OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise and novel and proprietary technologies.

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

BioReference Laboratories, Inc., a wholly-owned subsidiary of OPKO Health, is one of the largest and fastest growing full service diagnostic laboratories in the world, providing clinical testing services to physician offices, clinics, hospitals, long-term care facilities and employers while also advancing drug discovery and development with disease foundations, academic and pharmaceutical partners.

BioReference Laboratories’ comprehensive testing capabilities and expertise spans molecular diagnostics, anatomical pathology, women’s health, oncology and rare disease genetics. Its oncology and urology division, GenPath Diagnostics offers a comprehensive cancer patient workup in one laboratory. From routine clinical and special coagulation testing to complex genomic testing for tumor sequencing and hereditary cancer syndromes, the full spectrum of a cancer patient work-up is covered.

For more information, visit www.bioreference.com and www.genpathdiagnostics.com.