NIC TestRegistration

When would you like to take the miR Sentinel™ Prostate Cancer Test?

The miR Sentinel™ Prostate Cancer Test requires a medical provider’s evaluation to determine that the testing meets the stated indication and that all of your questions about the Test are answered. Once you complete and submit this form, a medical provider from Healthway Medical Group will reach out to you to schedule a telehealth appointment ahead of the NIC Conference. Medical consultation will not be available during the conference. By submitting this form you consent to miR Scientific sharing your personal information on this form with Healthway Medical Group for the purpose of ordering the Test.

Description of Test

The miR Sentinel™ Prostate Cancer Test is a clinical laboratory developed test (“LDT”) that aids in characterizing expression of RNA isolated from exosomes in urine. This test was developed and its performance characteristics determined by miR Scientific, LLC (CLIA ID #31D2256870). The U.S. Food and Drug Administration (FDA) has not approved or cleared this test; however, FDA approval or clearance is currently not required for clinical use of this test. The laboratory is regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing and has established and verified the test accuracy.

Test Results

The results may assist you and your provider in making informed choices relevant to your prostate cancer status. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions and should only be used by healthcare providers in conjunction with other tests and clinical information. Because of the complexity and important implications of the test results, miR Scientific sends your test results only to your designated provider(s). You may contact your provider to obtain your test results. miR Scientific maintains the confidentiality of your tests results and health information as required under applicable laws.

Interpretation of Test Results

Your provider will evaluate and discuss with you the results of your miR Sentinel™ test, in conjunction with your relevant clinical information in order to determine the best course of treatment for you. miR Scientific LLC does not offer any interpretative findings or evaluations. It is your provider’s responsibility to review the test results and provide you with their medical interpretation.

Intended Use
‍
This test can be used to help providers (i) detect the presence of prostate cancer, and (ii) if cancer is detected, to classify the risk of such cancer. The test is intended for genetic males only and is not intended to be used to test for cancers other than prostate cancer.

Test Procedure

You will be asked to provide a urine sample, which will be sent to the miR Scientific clinical laboratory in the United Statesfor processing.

Test Limitations

This test is limited to determining the expression of RNAs associated by the test with prostate cancer. This test does not measure a patient's inherited risk for prostate cancer and does not provide information on the anatomy or focality of a tumor. As new scientific information becomes available, such information could alter the interpretation or significance of test results. It is therefore recommended that patients proactively contact their provider for updated information regarding their test results at regular intervals in the future. Our test is not 100% sensitive or specific to prostate cancer. This test is subject to additional quality control or quality affairs to confirm the result. We may request an additional urine sample from you in order to ensure the accuracy of results.

The results may indicate a molecular tumor response associated with prostate cancer and therefore are not a diagnostic result of prostate cancer and should be interpreted along with other clinical assessment tests. Your provider may also recommend other laboratory tests, which may or may not be related to prostate cancer. Even if this test identifies the presence of prostate cancer, it is possible that it will not allow for a prediction of the prognosis or severity of an underlying disease. While there is a possibility that identifying the presence of prostate cancer may help direct management and treatment of the disease, it is also possible that this knowledge will not change or inform the management or treatment.