J&A_Redacted.pdf

NMLC LOG# 19-10030

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), Silver Spring, MD.

2. Description of the Action Being approved:

Award of a contract on a sole source basis for research, development, and manufacture of updated reagents in support of NMRC’s ongoing expansion of the bone marrow donor screening program.

The Government intends to award a firm fixed price contract to One Lambda, Inc. (One Lambda), 21001

Kittridge Street, Canoga Park, CA 91303-2801.

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

Development and manufacture of new HLA typing kits for combined bead based Sequence-

Specific Oligonucleotide (SSO) and reagents to support NMRC donor recruitment for HLA-A, HLA-B, HLA-C, HLA-DRB, HLA-DQB1, and HLA-DPAB alleles to detect and discriminate between alleles found in the Department of Defense (DoD) bone marrow 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.

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 including transplant donors and matched recipients.

This proposed action is a continuation of the effort 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, N62645-14-P-

2070, N62645-15-C-4032, N62645-16-C-4014, and N62645-17-C-4026.

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

The statutory exception permitting other than full and open competition for this acquisition is 10 USC

2304(c)(1), One source or limited sources. Refer also to FAR 6.302-1. There is only one responsible source, and no other supplies or services will satisfy agency requirements.

5. Rationale Justifying Use of Cited Statutory Authority:

One Lambda is the only known company to the Government that has the ability to continue to develop and manufacture new SSO typing kits to support NMRC donor recruitment HLA-A, HLA-B, HLA-C, HLA-

NMLC LOG# 19-10030

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.

With the use of two patents (LABType® & HLA Fusion™), One Lambda will continue this research. In addition, One Lambda is the only known company with the ability to continue to use the solid phase bead system to 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 that provides testing of tens of thousands of unique samples at research level genetic testing (allele level) with federal laboratory certification.

One Lambda is the only known company with the ability to 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. One Lambda is the only known company with the ability to continue to develop DNA primer pairs and sequence the 3.6 MB region of MHC 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 bone 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 20 May

2019 with a closing date of 28 May 2019. Thereafter, a Notice of Intent to sole source was synopsized on

FBO on 05 June 2019 with a closing date of 20 June 2019. No capability statements were received in response to either notice. 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 to perform the required work.

7. Determination of Fair and Reasonable Cost:

The Contracting Officer has determined the anticipated cost to the Government of the supplies/services covered by this J&A will be fair 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.

9. Contracting Point of Contact: