The PURE Index Test is a simple non-invasive urine test that provides an assessment of a patient’s risk for prostate cancer. It combines a biomarker along with patient PSA level and age in a complex algorithm that generates a Index for the risk of having prostate cancer diagnosed by prostate biopsy. The PURE Index Test recommends patients and doctors to make better-informed decisions in determining if a prostate biopsy is needed.
The PURE Index Test is a follow-up urine test after an abnormal PSA (PSA level >4ng/mL). It is a simple, non-invasive test with high accuracy of PCa risk evaluation. By specifically assessing the risk for prostate cancer after an abnormal screening result, the PURE Index Test could help avoid around 40% unnecessary biopsy, while distinguishing men with an elevated risk who may benefit from early intervention.
PURE Index Test measures the polyamine levels in urine. Level of the biomarker is combined with the patient’s clinical information and PSA level. Then, it is processed using a validated algorithm to calculate a patient’s individualized risk of finding prostate cancer if a prostate biopsy were to be performed.
The PURE Index Test can be used in the initial and subsequent management of patients with elevated PSA level. Clinical study confirms that the PURE Index Test is effective to identify men at higher risk of prostate cancer and could help reduce unnecessary biopsies. For patients with the low PURE Index or prostate biopsy does not show any evidence of cancer, one can perform the PURE Index test annually for monitoring purpose.
The PURE Index Test does not provide a diagnosis of prostate cancer. Instead, it is an evaluation of a patient’s risk for prostate cancer. The PURE Index is designed to help evaluate the necessity of performing a prostate biopsy.
The PURE Index Test provides an assessment of a patient’s risk for prostate cancer if a prostate biopsy were performed. Patients with an elevated PURE Index result should be considered for further evaluation and treatment. The PURE Index Test result should be interpreted in conjunction with other patient-specific information to develop a personal patient management plan.
- Patient with recent urinary tract infection within 6 weeks prior to urine collection.
- Patient with recent urethral instrumentation, such as Foley catheter insertion, cystoscopy etc., within 6 weeks prior to urine collection.
- Patient with digital rectal examination done within 7 days prior to urine collection.
- Patient with consumption of 5 alpha reductase inhibitors in the past 6 months.
- Patient with previous history of other malignant neoplasms
The PURE Index Test result can be received in the manner most compatible with the doctor’s needs. Results can be reported through courier delivery. There is also an easy-to-understand patient report that doctors can use to explain PURE Index Test results.