HEALTHCHART LLC — Department of Health and Human Services STTR Phase I: 102

Description

Project Summary Abstract Peripheral T cell lymphomaPTCLis a heterogeneous cancer that constitutes up toof all non Hodgkin lymphomaNHLThe World Health Organization classification recognizes a number of distinct subtypes of PTCL but the diagnosis of these different subtypes is challenging even for expert hematopathologistsFurthermoreof PTCL cases are not classifiable into any specific subtype at all using current diagnostic methodsPatients with PTCL generally have a poor prognosis with current standard of care therapyand no improvement in the outcome of PTCL patients has been achieved in the last two decadesHowevernovel therapies targeted to specific PTCL subtypes have recently begun testingsome with spectacular resultsAccurate diagnosis of PTCL and its subtypes has therefore become essential to ensure selection of the most appropriate and effective treatment for each individual patientThis project will leverage seminal work performed by academic investigators associated with the Lymphoma Leukemia Molecular Profiling ProjectLLMPPin which robust molecular gene expressionGEsignatures have been identified that are unique to each major subtype of PTCLThe project will build upon this workutilizing it as the basis for the creation of a commercial assay for routine clinical application to improve the diagnosistreatmentand outcomes of PTCL patientsHealthChart LLCa recently founded molecular diagnostics firm focused on the development of novel diagnostic assays for niche indications in cancer and other diseaseshas licensed the intellectual property and patent portfolio associated with the academic work and is the small business partner in these proposed studiesThe overarching goal of this PhaseSTTR proposal is to transition theacademicPTCL diagnostic and prognostic GE signatures originally developed using fresh frozen specimens analyzed with expression microarrays to an optimizedlocked down signature applicable to formalin fixed paraffin embeddedFFPEspecimens analyzed on the NanoString nCounter platformThe two Aims of this proposalAimIdentify a reduced set of transcripts and create a novel model able to replicate the existingacademicdiagnostic and prognostic PTCL signatureAimConfirm the applicability of the refined diagnostic and prognostic PTCL gene signature sets on the nCounter platformNanoStringfor the analysis of FFPE specimenswill create an optimized and locked down PTCL signatureestablish performance specifications for inter lab reproducibilityand validate the signature to a rigorous set of target metricsThese studies will enable application of the assay as a CLIA lab offering at the end of Phasewhile positioning the PTCL assay for transition to Phasedevelopment as an in vitro diagnosticIVDkit and possibly a companion diagnosticCDxfor novel and or existing PTCL therapies Project Narrative Peripheral T cell lymphomasPTCLare a heterogeneousdifficult to diagnose group of cancers that constitute up toof all non Hodgkin lymphomasNHLand are associated with a poor prognosiswith no improvement in outcomes over the past two decadesHowevernovel therapies targeted to specific subtypes of PTCL have recently begun to undergo testingsome with spectacular resultsThis scientific proposal describes the development of a novel clinical diagnostic test for commercial application that is designed to reliably identify the subtypes of PTCLthus helping to ensure the selection of the most appropriate and effective treatments for each individual patient and ultimately improving the outcomes of individuals with these cancers