Prostate Cancer Transition Research

The two main objectives of current research are (i) to achieve cGMP production certification of the proposed AptacheckTM In Vitro Multivariate Index Assay for screening and diagnosis of prostate cancer and also (ii) achieve CLIA certification for conducting PCa laboratory based tests.

Currently there are two common assays done in the CLIA labs for prostate cancer and they are the Prolaris® and the Oncotype Dx® assays, both the tests are genetic tests and they are do not help in detection of prostate cancer. These tests allow a physician to make better decisions on the risk and what types of chemotherapy will be likely to be effective. They are cleared for marketing by the US Food and Drug Administration (FDA) for use only in the CLIA lab setting. At this time they are not accepted as a way to diagnose or treat prostate cancer.

        The AptacheckTM in vitro Multivariate Index Assay developed by IPMD is a test for detection of PCa and therefore, obtaining CLIA certification is one of the key objectives of the proposal. IPMD is an ideal candidate to apply for the DOD prostate cancer research program of clinical-research transition award because IPMD has access to CLIA and cGMP certified lab space in Irvine. 

The proposed AptacheckTM concept is novel, the hypotheses are logical,  the preliminary findings are extremely promising and have been tested in patient population, the literature evidence is convincing and the research design is scientifically sound and flexible to include different US patient populations . There is indeed, confidence that the proposed research and cGMP and CLIA certification of AptacheckTM would lead to a new paradigm in diagnosing and managing prostate cancers in the US.