AN12--MVP ROAR DNA Sequencing Laboratory Services

The Million Veteran Program- Return of Actionable Results Study MVP_030 Statement of Work Contractor, is to provide laboratory services to the VA Boston Healthcare System (VABHS) to support the conduct of the VA Office of Research and Development funded study, MVP_030, The Million Veteran Program- Return of Actionable Results (MVP-ROAR) Study. The principal investigator for the MVP-ROAR Study is Jason L. Vassy, MD, MPH, SM, a VABHS clinician-investigator. Background: The MVP-ROAR Study is a pilot study associated with the Million Veteran Program (MVP) a VA research initiative developed to enhance the healthcare of Veterans. The MVP-ROAR Study is intended to generate knowledge about the processes and outcomes of returning genetic results for various genetic conditions identified by researchers in the Million Veteran Program. The MVP-ROAR Study will enroll patient-participants nationwide, for which genetic testing will be required. Through this study, patient-participants will undergo genetic testing and will receive an interpreted laboratory report from the Contractor provided to them and their healthcare providers through a VABHS genetic counseling intervention. Specimens for genetic testing will be collected at the participant s preferred local VA facility, or via an at home saliva collection kit, and will be shipped using a common carrier delivery service and standard chain of custody. All reports will be provided to VABHS study staff via a secure web-interface. Requirements Contractor is to have a Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) certified clinical diagnostic genetic testing laboratory. Vendor to counsel family on abnormal results. Vendor to have free family testing after reporting date of abnormal results. Description of Work VABHS wishes to contract for the laboratory services. Will need a company to perform DNA sequencing, analysis, interpretation, and reporting for this study. Primary contractor duties include, but are not limited to: Specimen accessioning, extraction, and test management Sequencing and deletion duplication analysis for the requested gene panel Bioinformatics annotation and filtration Data review and variant assessment Orthogonal confirmation as necessary Case interpretation, drafting, and reporting As-needed consultation with PI or genetic counselor for report interpretation Deliverables Specific items to be delivered to the VA investigator, include, but are not limited to: Human specimen sample collection supplies and shipping materials, compliant with all current federal regulations Interpreted report for each patient Free familial testing within 90 days of the report date, which has temporarily been extended to 150 days due to Covid-19. Timeframe Beginning and ending dates during which contractor is required to perform work for VABHS are January 9, 2022 to January 8, 2023 with the option to renew yearly through January 8, 2027.