Molecular Kits and Software for Lymphoid Malignancy Work-ups

DESCRIPTION provided by applicant The Specific Aim of this Phase II SBIR proposal is to develop four research use only RUO multiplexed molecular kits for comprehensive lymphoid malignancy pathology work ups Multiplexed amplification coupled with next generation sequencing NGS has a large awaiting market for pathology of lymphoid malignancy significantly decreasing material and labor costs compared with current methods Drs Kerschmann Zehnder andamp Negrin LOS For example current work ups for leukemia oligoclonality require laborious customization cost up to $ per subject and have a turnaround time of several weeks With around new lymphoid malignancies per year and $ per work up we estimate that the annual market for our kits in the US alone is $ million The technical innovation resulting from the Phase I SBIR project Johnson et al was a bioinformatics system for andquot cleaningandquot the non representative amplification that plagues multiplexed repertoire amplification Robins et al The market innovation resulting from this proposed Phase II SBIR project would be to provide a faster and cheaper system for lymphoid malignancy work ups that use immune repertoire analysis andquot GigaMune R HemeOncandquot In Phase II we will take the following steps to develop GigaMune R HemeOnc i manufacture four original equipment manufacturer OEM molecular kits that include amplification master mix amplification primers clean up reagents and positive control mixes ii implement web based analysis QC and QA software for the four molecular kits and iii use reference samples from the College of American Pathologists CAP to quantify the analytical validity of the kits and software We will be successful in our Phase II project if we achieve the following milestones i across replicate runs at GigaGen the OEM kits should amplify plasmid positive control mixes such that clonotypes present as low as have an average coefficient of variation CV of andlt power and with an area under the receiver operator characteristic curve AUC greater than power and ii across replicate runs at three testing sites the OEM kits should amplify reference samples such that clonotypes present as low as have an average CV of andlt power and with an AUC greater than power and a failure rate andlt After Phase II is complete we will market the RUO GigaMune R HemeOnc kits and software to pathology labs worldwide These kits and software will be best in class and facilitate clinical research and development of CLIA laboratory developed tests LDTs In the future we will explore the advantages of building GigaMune R HemeOnc into an FDA cleared in vitro diagnostic IVD kit For now the IVD route is not possible because there are currently no FDA cleared NGS systems that could be used in conjunction with GigaMune R HemeOnc PUBLIC HEALTH RELEVANCE Diagnostics laboratories often analyze immune cells to help characterize blood cancers such as leukemia and lymphoma We are building a streamlined cheaper and more comprehensive system for laboratories that analyze cancer samples