High Throughput SARS-CoV-2 Binding Antibody Immunoassay for Testing of Clinical Samples and Variant Assessment

PRE-SOLICITATION NOTICE OF INTENT
NON-COMPETITIVE

INTRODUCTION

PURSUANT TO FAR Subpart 5.2—Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT TO ACTION.   

THIS IS A PRE-SOLICITATION NON-COMPETITIVE NOTICE OF INTENT TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). 

The Division of Contracts Management and Acquisition (CMA) within the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (DHHS) proposes to enter into a sole-source contract using simplified procedures for certain commercial items included in FAR Subpart 13.5—Simplified Procedures for Certain Commercial Items.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 621511—Medical Laboratories with a Size Standard of $32.5M.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses of the Federal Acquisition Regulation (FAR) in effect through the Federal Acquisition Circular (FAC) 2021-07 (effective 9/10/2021)

STATUTORY AUTHORITY

This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and FAR Subpart 13.5—Simplified Procedures for Certain Commercial Items.

DESCRIPTION OF REQUIREMENT

Project Description

Title: High Throughput SARS-CoV-2 Binding Antibody Immunoassay for Testing of Clinical Samples and Variant Assessment

An outbreak of respiratory disease caused by a novel coronavirus was first detected in China in late 2019 and has now spread worldwide, including the United States (US). The virus has been named Severe Acute Respiratory Disease Coronavirus-2 (SARS-CoV-2) and causes Coronavirus Disease 2019 (COVID-19). The Federal Response, a joint HHS and Department of Defense (DOD) leadership team, is charged with development of COVID-19 vaccines and other medical countermeasures (MCMs). Viruses are constantly changing, and this includes SARS-CoV-2. A new virus variant has one or more mutations that differentiate it from the wild-type or predominant virus variants already circulating among the general population. As expected, multiple variants of SARS-CoV-2 have been documented in the United States and globally throughout this pandemic. The US Government (USG) is monitoring the situation closely. The federal government is working with state public health, academic, and commercial laboratories to increase domestic genomic surveillance to improve our ability to detect emerging variants. 

The USG entered into a contract with Neomed Laboratory Holdings Inc (DBA Nexelis Laboratories Canada Inc) in December 2020 (contract no. 75A50121P00015).  The objectives of that contract included: (1) to establish a high throughput multiplex MSD-ECL immunoassay for COVID-19 for use in testing of serum samples from human subjects enrolled in clinical trials of COVID-19 vaccines in compliance with Good Clinical Laboratory Practice (GCLP); and (2) to provide the USG with serologic data to support establishment of a correlate of protection to help facilitate expanded use of approved COVID-19 vaccines and accelerated approvals of additional vaccines.  Nexelis was successful in achieving those objectives, and the Government now has a need to continue sample testing using the assay validated by Nexelis under contract number 75A50121P00015.

Purpose and Objectives

The USG has a need for laboratory assay capacity sites for analysis of serum samples collected from subjects enrolled in COVID-19 vaccine clinical trials to provide serologic data to support the establishment of a correlate of protection to help facilitate expanded use of approved COVID-19 vaccines and accelerated approvals of additional vaccines.  Serum samples are tested to ascertain the ability of the vaccine to induce an immune response. The SARS-CoV-2 spike protein (S), which mediates binding to host cells, is highly immunogenic with the receptor-binding domain (RBD) being the target of many neutralizing antibodies. Serological analyses of COVID-19 vaccine trial specimens must be performed using the high throughput multiplex MSD-ECL immunoassay because it allows for simultaneous measurement of multiple SARS-CoV-2 proteins in the same well.

The objectives of this contract are: (1) test the clinical trial samples of COVID-19 vaccines using the validated MSD-ECL immunoassay for COVID-19 in compliance with Good Clinical Laboratory Practice (GCLP); (2) develop and validate assays for SARS-CoV-2 emerging variants by the Contractor; and (3) test serum samples from human subjects enrolled in clinical trials of COVID-19 vaccines using the variant assay in compliance with GCLP.

Period of Performance

The Government anticipates a one-year period of performance, and the desired start date is mid-December 2021.  The Government intends to issue a firm fixed price contract and anticipates the use of option quantities for additional sample testing.

CLOSING STATEMENT

This synopsis is not a request for competitive proposals.  However, interested parties may identify their interest and capability to respond to this notice. 

Responses to the eventual solicitation must include clear and convincing evidence of the offeror’s capability of fulfilling the requirement as it relates to the technical evaluation criteria.  The price proposal must include sufficient information to allow the Government to perform a basis analysis of the propose cost or price of the work.  The Government anticipates issuing a firm fixed price contract.

In addition, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.”

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.  The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.  

All responses must be received by 3:00PM EST November 26, 2021.and must reference solicitation number 75A50122R00007. 

Responses must be submitted electronically to Jeffrey Schmidt at jeffrey.schmidt2@hhs.gov and must reference the solicitation number 75A50122R00007on your electronic request.  FAX requests are not accepted.

“All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.”