Inactive

This synopsis is hereby issued in accordance with FAR Part 5.203(a). The purpose of this synopsis is to announce that the Office of the Biomedical Advanced Research and Development Authority (BARDA), ... This synopsis is hereby issued in accordance with FAR Part 5.203(a). The purpose of this synopsis is to announce that the Office of the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) intends to negotiate a Firm Fixed Price sole source contract with Monogram Biosciences, Inc, located at 345 Oyster Point Blvd, South San Francisco CA 94080 for the purposes of (1) testing of clinical trial samples of COVID-19 vaccines using the validated wildtype (WT) assay; (2) developing and validating assays for SARS-CoV-2 emerging variants; and (3) testing serum samples from human subjects enrolled in clinical trials of COVID-19 vaccines using the variant assay in compliance with Good Clinical Laboratory Practice (GCLP). The Government intends to negotiate solely with Monogram Biosciences, Inc. per FAR 6.302-1 as no other source will satisfy agency requirements. Under FDA regulatory requirement, the laboratory which has validated the assay for each vaccine company samples, would be required as the SARS-CoV-2 Spike pseudotyped Virus Neutralization (VN) assay performing site for the entire set of samples generated as part of its Phase 3 clinical trial. Therefore, both the early and late stage (durability of the immune response) time-points samples for each vaccine manufacturer have to be tested using the same assay and laboratory. Consequently, Monogram Biosciences Inc, is the only responsible source that can perform assays for the original Wuhan WT pseudotyped VN assay. Additionally, the FDA regulatory guidance for accelerated authorization of vaccines for SARS-CoV-2 emerging variants requires data from the exact same assay that was used for evaluation of the original Wuhan SARS-CoV-2 vaccine. Since Monogram Biosciences Inc, already has the validated Wuhan WT pseudotyped VN assay, only Monogram can perform the variant assessment in accordance with this regulatory requirement. The NAICS code for this acquisition is 541714, with a size standard of 1,000 employees. A determination by the Government not to compete the proposed acquisition based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No solicitation package will be issued. This notice of intent is NOT a request for competitive quotations. However, responses received by 11/02/2021 4:00 PM Eastern Time will be considered.