SBIR-STTR Award

The availability of a ruggedized, fully integrated STR typing instrument that combines DNA purification, amplification, separation and detection, and data analysis into a single, easy-to-operate system would represent a substantial advance in human identification. The purpose of the Phase I SBIR proposal is to plan the development of a device that enables the rapid determination of kinship of persons seeking to immigrate and of children being adopted overseas. The major tasks are: To conduct a DHS needs and requirements assessment for a fully integrated STR DNA typing instrument for the immigration application. Requirements to be defined will include throughput, cost, site and data security requirements, and user qualifications. To establish specific performance metrics for the device. Metrics will include: time to answer, sensitivity, and resolution and precision of the STR profiles. To study candidate enabling technologies and risks. Required performance metrics, technology readiness level, ability to integrate the modules, manufacturability, cost, and likelihood of system completion within the next two years will be evaluated. To define a viable technology architecture for the proposed device. This work will define technology architecture elements currently in place and areas requiring customization to address DHS needs and requirements.

First described in the early 1990's, short tandem repeat (STR) analysis is the gold standard of human identification. With a false identification rate as low as one in hundreds of trillions, STR analysis is a powerful tool for determining human identification objectively. The goal of this work is to improve the ability to evaluate kinship based on STR analyses. By creating an STR assay system that allows more accurate determination of kinship, DHS responsibilities such as granting asylum, processing applications for relatives to come to the US, and deterring child trafficking and illegal adoptions can be enhanced significantly. Current STR assays are highly effective for determining the likelihood of first degree relationships (parent-child and sibling-sibling) but are less effective at more distant relationships. By increasing the number of STR loci tested in a given assay, more distant relationships can be determined. The proposed work would result in such an improved assay, building on NetBio`s experience in designing systems that rapidly process nucleic acids without human intervention. It is hoped that this technology will improve the safety of society in general, and protect some of the most vulnerable members of our society in particular.