Tab_A16_J A_FBO.docx

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

1. Contracting Activity:

The Justification and Approval (J&A) is executed by the Naval Medical Logistics Command (NMLC), 693 Neiman Street, Fort Detrick MD 21702 on behalf of the requesting agency: Naval Medical Research Center (NMRC), Rockville, MD.

2. Description of the Action Being approved:

The proposed action is to expand on the development of the bone marrow screening program by continuing to improve the typing resolution and accuracy through improvements in the solid phase (bead) based system paired with Deoxyribonucleir acid (DNA) sequencing for Human Leukocyte Antigen (HLA). The Government intends on awarding a firm fixed price contract to One Lambda, Incorporation (Inc.), 21001 Kittridge Street, Canoga Park, CA 91303-2801

3. Description of the supplies or services required to meet the agency's needs:

The NMRC has a critical need to expand on the development of the bone marrow screening program by continuing to improve the typing resolution and accuracy through improvements in the solid phase (bead) based system paired with DNA sequencing for 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.

This effort is a continuation of research conducted under contracts N62645-08-P-2127, N62645-09-P-2187, N62645-10-C-4067, N62645-11-C-4049, N62645-12-C-4110, N62645-13-P-2067 and N62645-14-P-2070. The collaboration with NMRC in the past year under N62645-14-P-2070 has been very successful in developing specific probes and technology to improve assay resolution to meet the typing requirements of the DOD HLA typing program and donor registry of the C.W. Bill Young Marrow Donor Program. HLA alleles identified in the recent years have continued to increase dramatically, and the modified LABType DNA probe bead based system together with rapid DNA sequencing is now providing high resolution HLA results required for optimum donor selection for potential bone marrow transplantation. One Lambda, Inc. has been developing and testing reagents for solid-phase HLA typing for use by the NMRC program to HLA type approximately 30,000 to 60,000 volunteer marrow donors per year for entry into the C.W. bill Young Marrow Donor Program and the National Marrow Donor Program.

The contract is anticipated to be for a 12 month period of performance. The type of funds being utilized for this requirement is FY 2015 Navy Research, Development, Test and Evaluation (RDT&E).

4. Statutory Authority Permitting Other than Full and Open Competition:

10 U.S.C. 2304 (c)(1) (as implemented by FAR 6.302-1); Only one responsible source and no other supplies or services will satisfy agency requirements.

5. Rationale Justifying Use of Cited Statutory Authority:

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 Inc. 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 bead/sequencing system used by NMRC to improve genetic matching for marrow transplantation.

6. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable:

A sources sought notice was synopsized on the Federal Business Opportunities (FBO) website on 08 July 2015 and only One Lambda Inc. expressed an interest in this requirement. No additional market research was conducted because it is not practicable for the reasons discussed in paragraph 5 above, for any company other than One Lambda Inc. to perform the required work. Additionally, a notice of intent to award was synopsized on the FBO website on 13 July 2015 and no companies submitted a capability statement for this requirement.

7. Determination of Fair and Reasonable Cost:

The Contracting Officer will perform a cost and price analysis in order to determine whether the anticipated quotes received by the Government for the services covered by this J&A will be within fair market value and reasonable.

8. Actions to Remove Barriers to Future Competition:

For the reasons set forth in Paragraph 5, NMLC has no plans at this time to compete future contracts for the type of services covered by this document. If another potential source emerges, NMLC will assess whether competition for future requirements is feasible.