Services for indentification of mutations that affect the tenascin-X gene

The Department of Health and Human Services (DHHS), the National Institutes of Health (NIH), the Clinical Center (CC), in the Office of Purchasing and Contracts (OPC) has a need to continue existing genetic analysis laboratory services related to congential adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency, where patients are being seen under the Natural History Study of Patients with Excess Androgens, Protocol number: 06-CH-0011 which is currently being provided by Prevention Genetics, LLC in accordance with FAR 13.106-1(b). A major goal of this study is to evaluate genetic causes associated with certain clinical conditions. NIH/CC needs to provide results to patients, thus NIH/CC needs to use a Clinical Laboratory Improvement Amendments (CLIA) certified lab. This requires sending blood to a CLIA certified commercial laboratory. Prevention Genetics is a CLIA-certified laboratory that is currently offering and has offered genetic analysis and genetic sequencing of a gene of interest to the NIH/CC study: the tenascin-X gene which lies next to the CAH gene. NIH/CC are interested in screening some patients for a contiguous gene deletion that involves both the CAH gene and the tenascin-X gene. This is referred to as a chimera deletion. Prevention Genetics offers screening for this genetic mutation. Therefore, the need to assure continuity of protocol content and data control, the NIH/CC/OPC intends to sole source the requirement for the required laboratory services. The purpose of the work is to identify mutations that affect the tenascin-X gene for up to 100 samples on an annual basis. Government responsibilities, NIH/CC will be responsible for obtaining blood specimens from patients under an Internal Review Board (IRB) approved protocol and will be responsible for interpreting clinical implications of results. Reporting requirements of the laboratory shall provide a written report of the genetic analysis performed. Program management and control requirements for the laboratory shall be CLIA certified. Blood and/or DNA will be shipped from NIH/CC to Prevention Genetics according to the NIH/CC regulations and via courier- per company standards. It is NIH/CC/OPC's intent to sole source the requirement to: Prevention Genetics, LLC 3800 S. Business Park, Avenue Marshfield, WI 54449-9030 The NAICS code is: 621511. It is anticipated that one purchase order will be issued for a 1 year base period and 2 one year option periods. This is not a Request for Quote. Sources interested in this requirement must provide a statement of capabilities in sufficient detail to determine if the requirements of this synopsis can be met. Responses must be in writing and must be received within fifteen (15) calendar days from the date of this notice. A determination by the Government not to compete the proposed contract based on responses from this notice is soley within the discretion of the Government. Information received will be considered soley for the purpose of determining whether to conduct a competitive procurement. No phone calls will be accepted.