FAQs for Physicians about the 4Kscore Test for Prostate Cancer

Physicians Test for Prostate Cancer

The 4Kscore Test is the most accurate test to assess a patient’s risk for aggressive prostate cancer prior to a prostate biopsy.  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. The biomarkers utilized in the 4Kscore Test are based on over a decade of research conducted by scientists at Memorial Sloan Kettering Cancer Center and leading research centers in Europe on over 10,000 patients and a prospective, blinded clinical study conducted at 26 urology centers in the United States on 1,012 patients.

The 4Kscore Test measures the plasma 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, DRE status (nodule / no nodule), and history of prior biopsy status (prior prostate biopsy / no prior prostate biopsy). These elements are processed using a clinically validated algorithm to calculate the risk (probability) of a finding of prostate cancer with Gleason score 7 or higher if a prostate biopsy were to be performed.

The 4Kscore Test has the potential to dramatically increase the accuracy of prostate cancer diagnosis in the United States, particularly in its most aggressive forms.  Other clinical information may modify an individual patient’s risk and the decision to perform a prostate biopsy should be an individual choice based upon shared decision making between physician and patient.

The 4Kscore Test would benefit any patient for whom additional information about their risk (probability) of having aggressive cancer would enhance clinical decision-making before deciding to perform a prostate biopsy.

The 4Kscore Test can help urologists and physicians to identify patients who can benefit from biopsy while avoiding unnecessary biopsy for low-risk patients. The result is that more of the right patients get the diagnosis and treatment they need, while unnecessary biopsy is minimized.

The 4Kscore Test does not provide a diagnosis of prostate cancer. Rather, it is designed to help clarify the decision on whether or not to perform a biopsy based on the probability of a patient having aggressive prostate cancer.

OPKO Health assessed the performance of the 4Kscore Test in a recently concluded US Clinical Trial on 1,012 men. The biomarkers utilized in the 4Kscore Test are based on over a decade of research conducted by scientists at Memorial Sloan Kettering Cancer Center and leading research centers in Europe on over 10,000 patients and a prospective, blinded clinical study conducted at 26 urology centers in the United States on 1,012 patients.

The 4Kscore Test provides information on the risk (probability) of a man having aggressive prostate cancer (Gleason score 7 or higher). Other clinical information may modify an individual patient’s risk and the decision to perform a prostate biopsy should be an individual choice based upon shared decision making between Urologist and patient.

Yes. The biomarkers utilized in the 4Kscore Test are based on over a decade of research conducted by scientists at Memorial Sloan Kettering Cancer Center and leading research centers in Europe on over 10,000 patients. The results seen in the research phase have recently been validated by OPKO Lab in a prospective blinded clinical study conducted at 26 urology centers in the United States on over 1,012 patients. For more information, please see what is the 4Kscore Test.

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 and GenPath 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 and GenPath 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.

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 test’s 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 would like additional information or would like to become a client, please contact us to request a visit to your office by one of our sales representatives to discuss your service needs.

No, the 4Kscore test is not FDA approved, but is offered as a Laboratory Developed Test (LDT) through BioReference Laboratories and GenPath Diagnostics, both CLIA-Certified and CAP-Accredited laboratories and wholly owned subsidiaries of OPKO Health.

Do not use the 4Kscore Test for a patient:

  • With a previous diagnosis of prostate cancer
  • That has received a DRE in the previous 96 hours (4 days) before phlebotomy. A DRE performed after the phlebotomy is acceptable
  • That has received 5-alpha reductase inhibitor (5-ARI) therapy, such as Avodart® (dutasteride) or Proscar® (finasteride), within the previous six (6) months
  • That has undergone any procedure or therapy to treat symptomatic BPH or any invasive, urologic procedure that may be associated with a secondary PSA elevation prior to phlebotomy within the previous six (6) months
  • What is the turnaround time?

BioReference Laboratories and GenPath Diagnostics provide results within three business days for the 4Kscore Test. For turnaround time on other tests, please contact Customer Service at 1-800-627-1479.

You can receive the results in whatever manner is most compatible with your office’s needs. Results can reported through courier delivery, office fax, online reporting through CareEvolve, or direct interfacing into Electronic Medical Records (EMR).

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.

If you are interested in becoming a client or would like additional information, please contact us at 800-627-1479 to request a visit to your office by one of our sales representatives to discuss your service needs.