Expand the bone marrow screening program and continue to improve the typing resolution and accuracy by continuing improvements in the solid phase based system paired with DNA sequencing for HLA in support of Naval Medical Research Center

The Naval Medical Logistics Command (NMLC) intends to award a sole source contract under the authority of FAR 6.302-1 to One Lambda, Incorporation (Inc.), 21001 Kittridge Street, Canoga Park, CA 91303-2801; for the performance of a research and development (R&D) project in support of the Naval Medical Research Center (NMRC), Silver Spring MD. The estimated period of performance of the project is 12 months. The research project will support the Department of Defense (DOD) in expanding the bone marrow screening program and continuing to improve the typing resolution and accuracy by continuing improvements in the solid phase (bead) based system paired with Deoxyribonucleic acid (DNA) sequencing for Human Leukocyte Antigen (HLA). The objective is to develop an HLA typing system for donors that allow transplant centers searching for matched donors to identify these positively through complete allele level data on the search files used by the NMRC program to support potential patients and causalities of marrow toxic exposure. One Lambda, Inc. is the only source that has developed a high resolution (HD) rSSO (Reverse Sequence-Specific Oligonucleotide) DNA typing reagents in the LABType product family and accompanying In Vitro Diagnostic Medical Devices (IVD) analysis software (HLA Fusion). The collaboration of One Lambda, Inc. with NMRC since 2007 has been successful in continuing to develop specific probes to improve assay resolution and to meet the typing requirements of the DOD HLA typing program and bone marrow registry under the C.W. Bill Young Marrow Donor Program. One Lambda Inc. is the only source that will continue to develop and manufacture new SSO typing kits to support NMRC donor recruitment HLA-A, HLA-B, HLA-C, HLA-DRB, HLA-DQB1 and HLA-DPAB alleles to detect and discriminate between alleles found in the DOD bone marrow donor pool, even if they are rare in the general population. One Lambda will use 2 patents assigned by the U.S. Patent Office to continue this research. Further, One Lambda, Inc. is the only source who will continue to use the solid phase bead system and be paired with DNA sequencing capable of simultaneously analyzing multiple HLA loci as referenced above. This requires extensive use of both of One Lambda's 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. One Lambda Inc. will continue to develop and HLA test library preparation protocols and integration of existing NMRC automation equipment so that the software will be consistent with products being delivered. Further, given its patents, One Lambda, Inc. is the only company who can continue to develop DNA primer pairs and sequence the 3.6 MB region of major histocompatibility complex genes from HLA-A to HLA-DP and incorporate technology from this study into the existing proprietary bed/sequencing system used by NMRC to improve genetic matching for marrow transplantation. A sources sought notice was issued on 08 July 2015 for this requirement and the Government determined after the review of capability statements, that no other source had the capability to perform the required work. This notice of intent 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 and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. Capability statements shall not exceed 1 (8.5 x 11 inch) page and shall be submitted in 12 point, Times New Roman font. 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 5:00 PM Local Time, July 28, 2015. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: contact@example.gov.