The continued development and delivery of new reagents able to identify HLA alleles required for typing thousands of DoD volunteer marrow donors in NMRC's laboratory.
The Naval Medical Logistics Command (NMLC) intends to award a sole source contract to One Lambda, Inc. to support the Department of Defense (DoD) in expanding the bone marrow screening program require... The Naval Medical Logistics Command (NMLC) intends to award a sole source contract to One Lambda, Inc. to support the Department of Defense (DoD) in expanding the bone marrow screening program requirement for the Naval Medical Research Center (NMRC), Silver Spring, MD. This effort is a continuation of the development of high-resolution Human Leukocyte Antigen (HLA) typing reagents and methods for provision of developmental items to NMRC's HLA typing program and Bone Marrow Research Department, C. W. Bill Young Marrow Donor Program under Contract N62645-17-C-4026 awarded to One Lambda, Inc. The anticipated period of performance of this requirement is 12 months. If capable sources are not identified through this notice, NMLC intends to award a sole source contract under the authority of 10 U.S.C. 2304(c)(1), (as implemented by FAR 6.302-1) to One Lambda, Incorporation (Inc.), 21001 Kittridge Street, Canoga Park, CA 91303-2801 for the performance of the described requirement. The continued rapid increase in the number of newly defined HLA alleles requires continued development and delivery of new reagents able to identify HLA alleles required for typing thousands of DoD volunteer marrow donors in NMRC's laboratory. These reagents will include reagent "spikes" (special DNA probes) specifically required by NMRC as an incorporated component of the developed probe-typing bead reagents to be delivered to NMRC for typing donors. This effort will continue to incorporate technology from this study into the existing proprietary bead/sequencing system used by NMRC to improve genetic matching for marrow transplantation. The description of the supplies and services required to meet NMRC's needs include building upon the research provided under the prior contract (N62645-17-C-4026) to: • Develop and manufacture new HLA typing kits for combined bead based SSO sequencing, and to provide the reagents to support NMRC donor recruitment for HLA-A, B, C, DRB, DQB, and DPAB alleles to detect and discriminate between alleles found in the DoD BM donor pool, even if they are rare in the general population; • Develop and HLA test library preparation protocols and integration of existing NMRC automation equipment and modification of One Lambda software to be consistent with products being delivered; and • Test, evaluate, and extend development of DNA primer pairs, DNA capture, and sequencing of the 3.6 MB region of the major histocompatibility complex (MHC) genes. This will continue to increase the ability to identify unique gene sequences in the MHC genetic region to identify MHC haplotypes specific sequences that can be used for sequence specific oligonucleotide probe (SSOP) beads and DNA sequencing for identifying genetic characteristics of MHC that affect clinical outcome in unrelated donor transplants. Multiple genetic samples will be evaluated for consistency of identifying MHC haplotypes and to evaluate the haplotype (the linked set of alleles from within the MHC on chromosome 6 from HLA-A to HLA-DP) testing system in samples from complex genetic backgrounds based on known HLA alleles. The C. W. Bill Young Marrow Donor Program will be provided the laboratory tools to be able to determine the specific haplotypes of each individual tested (haplotypes are the HLA - A, B, C, DR, DQ, DP as a linked set together with intervening MHC genes on each of the two haplotypes of individuals (one maternal and one paternal haplotype)). The research efforts require continued use of the incumbent's two patents, exclusive license, and proprietary technology providing testing of tens of thousands of unique samples at research level genetic testing (allele level) with federal laboratory certification for continued development of HLA test library preparation protocols and integration of existing NMRC automation equipment so that the software will be consistent with products being delivered. This effort will further refine the solid-phase HLA test system and reagents, provide these for approval by the Navy and for HLA typing of volunteer donors for donor registration. The high capacity high resolution system will use the solid phase bead system and be paired with DNA sequencing capable to simultaneously analyzing multiple HLA loci (HLA-A, HLA-B, HLA-C, HLA-DRB, HLA-DQB1 and HLA-DPAB). This notice is not a request for competitive proposals, and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data, as well as cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. Capability statements shall not exceed one (8.5 x 11 inch) page using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source contract. Capability statements are due by 2:00PM Eastern Time, 20 June 2019. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: jesse.d.nisley.civ@mail.mil.
Links ()
Attachments ()
Data sourced from SAM.gov.
View Official Posting »