QUANTIFICATION TESTING FOR CLINICAL TESTING FOR PHASE 2 TRIALS AND ASSAY REAGENT SUPPLIES

This is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis with Meso Scale Discovery (MSD), a division of Meso Scale Diagnostics, LLC of Rockville, MD for the following:

MA6000 384-well Prototype anti-L9LS Singleplex - QTY:300 with shipping and handling cost to VIP Lab, 9 West Watkins Mill Road, Gaithersburg, MD 20878 The supplies/services to be purchased MA6000 384-well Prototype anti-L9LS Singleplex x 300 plates provide quality documentation for each lot of plates provided under this PO such as a certificate of analysis or equivalent.

This requirement is to procure a quantification service for the Meso Scale Discovery (MSD) SECTOR S600 reader purchased new in FY23, as well as additional assay plate supplies for said reader. The VIP is performing clinical testing for phase 2 trials NCT05816330 and NCT05400655. With samples being collected and stored from these trials, a timely analysis of these samples is required to inform the dosing and administration strategy for additional trials being organized for this monoclonal antibody therapeutic.

The supplies/services to be purchased MA6000 384-well Prototype anti-L9LS Singleplex x 300 plates provide quality documentation for each lot of plates provided under this PO such as a certificate of analysis or equivalent. This requirement is to procure a quantification service for the Meso Scale Discovery (MSD) SECTOR S600 reader purchased new in FY23, as well as additional assay plate supplies for said reader.

For the integrity of our clinical testing for phase 2 trials, it is imperative that we only use the same reagents and services. This is a sole source requirement for these reasons. The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL.

All responsible sources that could provide comparable services may submit a capability statement that will be considered by email (subject line to reference NOI-RML-24-2218672) to Diana Rohlman at diana.rohlman@nih.gov, by 4:00 pm EST April 16, 2024. All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.