Inactive

CLIA-accredited laboratory that is uniquely able to provide screening for the chimera deletion. Product Service Code: Q301 NAICS Code: 621511 Place of Performance: Bethesda, MD 20892 POTS: 23-008554 D... CLIA-accredited laboratory that is uniquely able to provide screening for the chimera deletion. Product Service Code: Q301 NAICS Code: 621511 Place of Performance: Bethesda, MD 20892 POTS: 23-008554 Description This is a notice of intent, not a request for a quotation. A solicitation document will not be issued and quotations will not be requested. The National Institutes of Health (NIH) intends to award a Firm Fixed Price contract with a twelve (12) month base year to PREVENTION GENETICS, LLC. Marshfield, Wisconsin 54449-9030 on a sole source basis to provide genetic analysis and genetic sequencing of the tenascin X gene. It is the only US laboratory providing this service for this gene. It is also the only US laboratory offering screening for the chimera deletion for the Pediatrics Department (PEDS) at the NIH Clinical Center (CC). In support of a clinical research project, we need to perform genetic analysis related to congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. Patients are being seen under the Natural History Study of Patients with Excess Androgens, Protocol # 06-CH-0011. A major goal of this study is to evaluate genetic causes associated with certain clinical conditions. We need to provide results to patients; thus, we need 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 offers genetic analysis and genetic sequencing of a gene of interest to our study and associated with CAH: the tenascin-X gene which lies next to the CAH gene. No other CLIA certified laboratory offers tenascin-X genetic analysis. We 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 and sequencing of the tenascin-X gene. This acquisition is being conducted using policies unique to the Federal Acquisition Regulation (FAR) Part 13 – Simplified Acquisition Procedures, Subpart 13.106-1(b)(1), For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. Interested parties may identify their interest and capabilities in response to this posting. The determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government. Comments to this announcement, referencing this posting number, may be submitted to the CC, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Gregory Noland, Contract Specialist, gregory.noland@nih.gov by the due date (08/30/2023) marked in this notice.