Quantification testing for clinical testing for phase 2 trials and assay reagent supplies
Closed Pre-Solicitation Posted
- Solicitation number
- NOI-NIAID-24-2218672
- Agency
- National Institute of Allergy and Infectious Diseases National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 325414 Biological Product (except Diagnostic) Manufacturing
- PSC
- 6505 Drugs And Biologicals
- Place of performance
- Gaithersburg, Maryland 20878, United States
- Points of contact
-
- Jesse jesse.weidow@nih.gov
- Diana Rohlman diana.rohlman@nih.gov (406) 363-9366
Notice details come from SAM.gov. Updated .
About this opportunity
Paragraph 1:
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, for the procurement of 300 units of MA6000 384-well Prototype anti-L9LS Singleplex plates. These supplies and services are required to provide a quantification service for the MSD SECTOR S600 reader, as well as additional assay plate supplies, to support clinical testing for phase 2 trials. The requirement is a sole source due to the need to use the same reagents and services for the integrity of the clinical testing. The deadline for submitting capability statements is 4:00 pm EST on April 16, 2024.
Paragraph 2:
This procurement is not set aside for any specific program. The relevant NAICS code is likely 541711 (Research and Development in Biotechnology), and the applicable PSC code is likely 6515 (Laboratory Equipment and Supplies). Meso Scale Discovery (MSD) is the potential incumbent for this requirement. The total value of the contract is not specified, but the requirement is for 300 units of the MA6000 384-well Prototype anti-L9LS Singleplex plates.
Notice text
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.
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