JA_for_N62645-17-C-4026.pdf

NMLC LOG #

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:

One Lambda, Inc. has developed high resolution (HD) Reverse Sequence-Specific Oligonucleotide (rSSO) Deoxyribonucleic acid (DNA) typing reagents in the LABType® product family and accompanying In Vitro Diagnostic Medical Devices (IVD) analysis software (HLA Fusion™) with specific DNA probes for testing Human Leukocyte Antigen (HLA) genes on DNA extracts from cells from bone marrow donors. This proposed action will continue to improve the accuracy and efficiency of the existing system and be paired with DNA sequencing, in order to provide additional critical information and typing reagents for typing potential marrow donors and patients and assists with the development of linking the series of HLA genes together as a haplotype.

The Government intends on awarding 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 sequencing and provide the reagents to support NMRC donor recruitment for HLA A, B, C, and DRB, DQB and 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 genes. This will continue to increase the ability to identify unique gene sequences in the major histocompatibility complex (MHC) genetic region to identify MHC haplotypes specific sequences that can be used for Sequence-Specific Oligonucleotide Probe (SSOP) beads 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 major histocompatibility complex 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. 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).

NMLC LOG

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, and N62645-16-C-4014.

The contract is anticipated to be for a 12 month period of performance. The type of funds being utilized for this requirement is FY 2017 Navy Research, Development, Test and Evaluation (RDT&E).

The estimated value of this contract is $2,300,000.00.

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) (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 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 (LABType® & HLA Fusion™) to continue this research. Further, One Lambda 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 that provides testing of tens of thousands of unique samples at research level genetic testing (allele level) with federal laboratory certification.

One Lambda 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 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 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 21 July 2017 and no capability statements were received. In addition, a notice of intent to sole source was synopsized on the FBO website on 26 July 2017 and no capability statements were received. 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 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.

NMLC LOG #

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:

The point of contact at NMLC is Cheryl Vendemia, 301-619-6004 or by email at cheryl.r.vendemia.civ@mail.mil.

See Approvals on Next Page mailto:cheryl.r.vendemia.civ@mail.mil

NMLC LOG #17-10174

TECHNICAL/REQUIREMENTS CERTIFICATION

I certify that the facts and representations under my cognizance which are included in this Justification and its supporting acquisition planning documents, except as noted herein are complete and accurate to the best of my knowledge and belief.

TECHNICAL/REQUIREMENTS COGNIZANCE

Naval Medical Research Center

LEGAL SUFFICIENCY REVIEW AND CONCURRENCE

I have determined this Justification is legally sufficient.

Legal Counsel, Code 00L Phone Date

CONTRACTING OFFICER CERTIFICATION

I certify that this Justification is accurate and complete to the best of my knowledge and belief. To the extent that the J&A/LSJ value is between $150K and $650K, the Contracting Officer’s signature below also represents approval of the J&A/LSJ.

Contracting Officer

COMPETITION ADVOCATE REVIEW

To the extent that the J&A/LSJ value is between $650K and $12.5M, the Competition Advocate’s signature below also represents approval of the J&A/LSJ.

Competition Advocate