Implementation and Trial Preparation Considerations: A Case Review of the First Successful NGS Admissibility Hearing in the US

Implementation and Trial Preparation Considerations: A Case Review of the First Successful NGS Admissibility Hearing in the US

Next generation sequencing (NGS) has slowly been gaining traction internationally over the last decade in forensic science. The last 5 years has seen an uptick in the usage in laboratories in the United States with the release of numerous commercially available forensic systems, and even National DNA Index System (NDIS) approvals of some of these systems. Assessment, acquisition and validation of new technology is frequently a significant challenge for forensic laboratories. Forensic laboratory decision makers prefer to see technology proven to be fit for purpose prior to committing limited resources, particularly when case backlogs exist. Few forensic laboratories have the luxury of dedicated research and validation sections; therefore, staff must do double duty of conducting casework while evaluating technology potential for application to casework. Toward the end goal of having their technology successfully used in the hands of forensic laboratories, technology vendors must conduct developmental validations and support early adopters with information regarding their application. There is however a gap between technology vendors and the first forensic laboratories to implement the technology, where the next steps of technology acquisition, methods development, validation, and application to actual casework need to occur. Further, passing necessary accreditation, internal and external audits, and evidentiary admissibility in court are also significant landmarks increasing confidence of potential adopters. There are approximately 409 forensic laboratories and 203 DNA CODIS laboratories in the United States, the majority of which operate independently. With each of these laboratories conducting independent preliminary internal validation studies, there is potential for a lot of duplicative work which can be avoided by sharing validation information, including procedures and parameters, validation studies, and data. Collaborative or shared validation permits laboratories an easier mechanism to adopt existing procedures and parameters which have shown to be successful in original adopting laboratories. New laboratories can piggyback existing validation models and apply useful aspects of existing sample sets and other laboratories’ experience. New laboratories benefit from increased confidence they are running the right type, number replicates of samples, and are obtaining the correct answer through inter-laboratory comparison of data and results. A collaborative validation study has been conducted in the United States including DNA Laboratories International (Deerfield Beach, FL), New York State Police Crime Laboratory System (Albany, NY) and Kern Regional Crime Laboratory (Bakersfield, CA). This research sought to demonstrate concordance and reproducibility between replicate mock casework samples using the MiSeq FGx Sequencing System and the ForenSeq DNA Signature Prep Primer Set B Kit. Six (6) known samples from a variety of typical forensic sample types were prepared by one of the partner forensic laboratories (Kern County) in triplicate and shared among the participants. These samples included semen, blood and saliva, applied to frequently occurring substrates of fabric, swab and exhibit material. Each laboratory analyzed the samples using nearly identical procedures and interpretation guidelines, enabling comparison of data to evaluate repeatability and reproducibility. The results of this study will be discussed. Mandi S. Van Buren, MS1, Rachel Oefelein, MSc1, Cristina Servidio, MFS1, Dr. Ray A. Wickenheiser2, Russell R. Gettig, PhD2, Anthula V. Vandoros, PhD2, Jamie L. Belrose, PhD2, Jolin R. Z. Koch, MS2 1 – DNA Labs International, 2 – New York State Police Crime Laboratory System

Next generation sequencing (NGS) has slowly been gaining traction internationally over the last decade in forensic science. The last 5 years has seen an uptick in the usage in laboratories in the United States with the release of numerous commercially available forensic systems, and even National DNA Index System (NDIS) approvals of some of these systems. Assessment, acquisition and validation of new technology is frequently a significant challenge for forensic laboratories. Forensic laboratory decision makers prefer to see technology proven to be fit for purpose prior to committing limited resources, particularly when case backlogs exist. Few forensic laboratories have the luxury of dedicated research and validation sections; therefore, staff must do double duty of conducting casework while evaluating technology potential for application to casework. Toward the end goal of having their technology successfully used in the hands of forensic laboratories, technology vendors must conduct developmental validations and support early adopters with information regarding their application. There is however a gap between technology vendors and the first forensic laboratories to implement the technology, where the next steps of technology acquisition, methods development, validation, and application to actual casework need to occur. Further, passing necessary accreditation, internal and external audits, and evidentiary admissibility in court are also significant landmarks increasing confidence of potential adopters. There are approximately 409 forensic laboratories and 203 DNA CODIS laboratories in the United States, the majority of which operate independently. With each of these laboratories conducting independent preliminary internal validation studies, there is potential for a lot of duplicative work which can be avoided by sharing validation information, including procedures and parameters, validation studies, and data. Collaborative or shared validation permits laboratories an easier mechanism to adopt existing procedures and parameters which have shown to be successful in original adopting laboratories. New laboratories can piggyback existing validation models and apply useful aspects of existing sample sets and other laboratories’ experience. New laboratories benefit from increased confidence they are running the right type, number replicates of samples, and are obtaining the correct answer through inter-laboratory comparison of data and results. A collaborative validation study has been conducted in the United States including DNA Laboratories International (Deerfield Beach, FL), New York State Police Crime Laboratory System (Albany, NY) and Kern Regional Crime Laboratory (Bakersfield, CA). This research sought to demonstrate concordance and reproducibility between replicate mock casework samples using the MiSeq FGx Sequencing System and the ForenSeq DNA Signature Prep Primer Set B Kit. Six (6) known samples from a variety of typical forensic sample types were prepared by one of the partner forensic laboratories (Kern County) in triplicate and shared among the participants. These samples included semen, blood and saliva, applied to frequently occurring substrates of fabric, swab and exhibit material. Each laboratory analyzed the samples using nearly identical procedures and interpretation guidelines, enabling comparison of data to evaluate repeatability and reproducibility. The results of this study will be discussed. Mandi S. Van Buren, MS1, Rachel Oefelein, MSc1, Cristina Servidio, MFS1, Dr. Ray A. Wickenheiser2, Russell R. Gettig, PhD2, Anthula V. Vandoros, PhD2, Jamie L. Belrose, PhD2, Jolin R. Z. Koch, MS2 1 – DNA Labs International, 2 – New York State Police Crime Laboratory System

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Worldwide Association of Women Forensic Experts

Mandi Van Buren

DNA Analyst, DNA Labs International (DLI)

Mandi Van Buren began her forensic career at the Utah Bureau of Forensic Services and now has over 15 years of experience as a DNA analyst in forensic casework, crime scene processing and 7 years as a drug chemist.  Beyond casework, her expertise is in advanced DNA technologies such as next generation sequencing (NGS) and probabilistic genotyping including validations, implementation, training and expert testimony. 

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