2_JA 2117422.docx

Justification for Other than Full and Open Competition:

Meso Scale Discovery at or Below the Simplified Acquisition Threshold

Project Title: Meso Scale Discovery SARS CoV-2 kits

Identification of the agency and contracting activity:

DHHS, NIH, NIAID, VRC, VIP

Address of the requesting lab/office: 9 West Watkins Mill Rd, Gaithersburg, MD 20878

Description of the project and supplies or services required to meet the agency's needs Project Background

a. The Vaccine Immunology Program (VIP) aids the Vaccine Research Center (VRC) by supporting the development of monoclonal antibodies and vaccines for infectious diseases such as HIV, Influenza, Ebola and more recently SARS-CoV-2 Coronavirus. Support is through the state-of-the-art laboratory performing Phase 1 and Phase 3 clinical end point testing to inform further study designs, research questions and vaccine modification and design. As part of a broader strategy to accelerate the development of monoclonal antibodies as therapy for targeting SARS CoV-2 spike and its newly emerging variants, VIP has identified the electro chemiluminescent (ECL) assay format as the most reliable and sensitive assay system that offers high dynamic range in the detection of antibodies isolated specific to SARS-CoV-2 spike (S2P). Specifically, the VIP is in the process of developing an assay for detection of binding antibodies to subdomains of the spike such as RBD, NTD, S1 and S2, which offers high throughput measurement of immune responses elicited by infections. The VIP needs the plates to perform the assay testing in support of SARS CoV2 therapeutic antibody isolation and development project.

This reader is only compatible for use with kits manufactured and sold by Meso Scale Discovery LLC, such as the V-PLEX SARS-CoV-2 Panel 25 Kit.

Product needed:

Manufacturer: Meso Scale Discovery

Identification of the statutory authority permitting other than full and open competition:

· 41 USC 1901(a)(l) and FAR Part 13.106-1(b): Only one responsible source/Brand Name

Demonstration that the proposed contractor unique qualifications or the nature of the acquisition requires use of the authority cited.

Name and address of the proposed contractor:

Meso Scale Discovery 1601 Research Boulevard Rockville MD 20850

Describe why only the requested brand name of the supply will meet the government's needs:

As the threat of COVID-19 continues in the international community with new variants emerging every week, the need for a safe and efficacious monoclonal antibody therapy at an accelerated timeline is a health care priority. To assist in this effort, the VRC-VIP will use the electro chemiluminescent (ECL) assay format which they have recently developed for a SARS CoV-2 specific assay for the detection of specific antibodies directed towards SARS CoV-2 S-2P (or other stabilized version of this same protein), variants and subvariants (B.1.1.529, AY.4, B.1.1.7, B.1.351, B.1.640.2). Spikes that are 'printed' or 'spotted' in a single well of a MSD 96-well microtiter plate. The VRC-VIP identified the ECL assay as the most reliable and sensitive assay system over the last 10 years, that offers high dynamic range in the detection of specific serum antibodies generate towards a variety of viral proteins. The platform offers extremely high throughput for the simultaneous measurement of antibodies to their epitopes. This reader is only compatible for use with kits manufactured and sold by Meso Scale Discovery LLC, such as the V-PLEX SARS-CoV-2 Panel 25 Kit.