SBIR Diagnostic Method to Identify approved drugs as treatment options in individuals with rare cancer

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The long term objective of this proposal is to improve outcomes for ovarian cancer patients in the frontline setting. Few effective drug treatment options exist for ovarian cancer and other rare cancers whereas 300+ drugs have been approved by the FDA to treat non-rare cancers. Analysis of tumor mRNA gene expression has the potential to identify over expression of approved drug targets, such as HER2, AR, and PD-L1, and silencing of DNA repair genes that make ovarian tumors more responsive to PARP inhibitors. In this project, a proprietary tumor mRNA sequencing method called “OneRNA” will be analytically validated in 30 clinically annotated de-identified ovarian tumors by (1) comparing relative mRNA expression levels (tumor vs normal) to reverse transcriptase PCR (RT-PCR) (2) evaluating concordance of aberrantly expressed genes detected with the OneRNA assay with FDA approved immunohistochemical (IHC) assays. Based on preliminary data, we expect to identify at least one clinically actionable aberrantly expressed gene in over 90% of tumors. The resulting data will support the launch of an ovarian tumor expression analysis service by the Genomic Expression CLIA lab to help oncologists identify which drugs and drug combinations are likely to benefit ovarian cancer patients.