Information about 4kscorestest

¿Is the 4Kscore test scientifically tested?

The 4Kscore Test has undergone extensive clinical development and confirmation. The biomarkers utilized in the 4Kscore Test are based on over a decade of research conducted by scientists at the Memorial Sloan Kettering Cancer Center and leading research centers in Europe, encompassing over 10,000 men in Europe and the United States. The results have recently been replicated in a prospective, blinded clinical study conducted at 26 urology centers across the United States on 1,012 patients.
The test has been shown to identify the actual risk of aggressive prostate cancer for the individual patient, including agressive prostate cancer pathology and poor prostate cancer clinical outcomes within 20 years, with both high sensitivity and negative predictive value for aggressive prostate cancer.

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¿Who needs the 4Kscore Test?

Any man with doubts about having a prostate cancer and whose urologist has indicated the test, to decide if a biopsy is necessary. In many cases, the result of the 4Kscore test can give information about an indolent pathology, and therefore it wouldn’t be necessary to perform a biopsy, which is always uncomfortable and is not free of adverse events.

THE TEST SHOULD NOT BE USED FOR:
1. A patient with a previous diagnosis of prostate cancer.
2. A patient that has received a DRE in the previous 96 hours (4 days) before phlebotomy. A DRE performed after the phlebotomy is aceptable.
3. A patient that has received within the previous six (6) months 5-alpha reductase inhibitor (5-ARI) therapy such as Avodart® (dutasteride) or Proscar® (finasteride).
4. A patient that has undergone within the previous six (6) months 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. Such therapies or procedures include, but are not limited to, prostate biopsy, thermotherapy, microwave therapy, laser therapy, TURP, urethral catheterization and lower genitourinary tract endoscopy.

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¿What does the 4Kscore Test result mean?

The 4Kscore test evaluates the analytical and clinical parameters to provide an individualized risk of having agressive prostate cancer. The result is easy to interpret. For example: if the 4Kscore test gives a risk of 7%, it means that 7 out of 100 patients in the same situation will have an agressive prostate cancer.
A result of a 20% means that 20 out of 100 patients in the same situation will have an agressive-prostate cancer.
And the same applies to each of the values, from 1% to 99%. There are not indetermined results with the 4Kscore test, therefore, the information is always valid as an assistance in the decision-making process.

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¿How do I order the 4Kscore test?

After the recommendation by an urologists, in order to have additional information in the decision-making process in the prostate cancer diagnostic process and the need of a biopsy, the patient should go to one of our authorised labs for a phlebotomy. The sample will be processed for the 4Kscore and the doctor will receive the results in a few days. To know which is the phlebotomy site more convenient contact your urologist or our Customer Service representative:

 

900 102 167
Mail: customerservice.europe@opko.com

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