2_JA 2134476 MSD.pdf

Justification for Other than Full and Open Competition at or Below the Simplified Acquisition Threshold

Project Title: Meso Scale Brand MULTI-SPOT 96 10-Spot Custom SARS CoV-2 Panel

I . Identification of the agency and contracting activity

DHHS, NIH, NIAID, VRC, VIP

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

II. Description of the project, and supplies or services required to meet the agency’s needs

A. 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 viral antigens, VIP has identified the electrochemiluminescent (ECL) assay format as the most reliable and sensitive assay system that offers high dynamic range in the detection of antibodies isolated specific to viruses. 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.

B. Project Description The Vaccine Immunology Program (VIP) of the National Institutes of Allergy and Infectious Diseases (NIAID) is seeking to procure Meso Scale Discovery kits. The objective is to supply the plates for the VIP to perform the assay testing in support of SARS CoV2, Ebola, HIV, and Flu theraputic antibody isolation and development projects.

Manufacturer:

Meso Scale Discovery

Product needed:

MULTI-SPOT 96 10-Spot Custom SARS CoV-2 Panel Catalog #N05CA-1

QTY: 300

Includes

- CoV-2 Spike RBD

- RBD B.1.1.529 (BA.1)

- RBD B.1.1.529 (BA.2)

- RBD B.1.1.529 (BA.1.1)

- RBD Delta AY.4

- RBD B.1.1.7

- RBD B.1.351

- RBD P.1

Provide all accompanying reagents, including but not limited to:

• SULFO TAG Anti Human lgG Antibody

• Calibrator/Normalization Reagent

• MSD Blocker A

• Diluent 100

• MSD Gold Read Buffer B

• Wash buffer

III. Identification of the statutory authority permitting other than full and open competition 41 USC 1901(a)(1) a nd FAR Pa r t 13 .106- 1 ( b ) : Only one responsible source/Brand Name

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

A. Name and address of the proposed contractor(s)

Meso Scale Discovery 1601 Research Blvd Rockville, MD 20850 301-524-7997

B. Describe why only the requested supply/service will meet the government’s needs Many viruses continue to circulate 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 electrochemiluminescent (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 and RBD (or other stabilized version of this same protein), variants and subvariants (B.1.1.529, AY.4, B.1.1.7, B.1.351, P.1). These paltes will also allow us to screen for many other viruses including Ebola, Flu, and HIV. RBD proteins 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.

Since the multip-plex assyas used for Ph1 and Ph3 testing is on the MSD platform, it is very logical to also develop the 10-plex assays on the same platform for ease of testing and familiarity of the technology and utilization of the current instruments in the lab.