KIT COBAS 58/68/8800 HIV 192T IVD and related control reagents through Roche Diagnostics

PRE-SOLICITATION NOTICE **NOTICE OF INTENT TO SOLE SOURCE NOI-NIAID-24-2260950 NAICS – 325414 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 Roche Diagnostics Corporation to provide: KIT COBAS 58/68/8800 HIV 192T IVD, Catalog# 9040803190, Quantity 17 EA (to be delivered over 8 shipments between June 2025 - Feb 2026) Shipping/Handling fees to Bethesda, MD The Laboratory of Immunoregulation (LIR) focuses its research efforts on the elucidation of cellular and molecular mechanisms of the regulation of the human immune response in health and disease.

A major component of these efforts is focused on the study of the mechanisms of viral persistence in human immunodeficiency virus (HIV) infected individuals receiving antiretroviral therapy (ART). The advent of ART has dramatically improved the clinical outcome in HIV-infected individuals through sustained reduction in viral replication.

However, it has become clear that ART alone cannot eradicate HIV in infected individuals, likely in part due to the persistence of viral reservoirs in peripheral blood and various tissue compartments. Consequently, a major thrust of HIV research over the past several years has been to develop therapeutic strategies that can eliminate persistent viral reservoirs and boost host immunity to control viral replication upon discontinuation of ART.

Given lack of efficacy and difficulties encountered with modalities, such as HIV purging agents and chemotherapy and stem cell transplantation, a more realistic approach is needed to explore the therapeutic strategies that harness host immunity to control HIV replication in infected individuals in the absence of ART.

To that end, the LIR requires 17 kits of COBAS 58/68/8800 HIV 192T IVD and related control reagents from Roche Diagnostics for use in long-standing research projects in the area of HIV/AIDS Pathogenesis. Use of these kits determines plasma viremia in people living with HIV who are enrolled in two ongoing clinical trials initiated prior to 1/20/2025 The clinical trials are ClinicalTrials.gov IDs NCT05582694 and NCT05612178.

The reagent requested is to be used in the most critical step of research analyses wherein the lab needs to quantitate HIV RNA in the plasma and culture supernatants in a highly reproducible way. The reagents on this requirement are designed specifically for the existing instrument. In addition, changing instruments/reagents would introduce a variable that would impede the lab’s ability to compare both cross-sectional and longitudinal assays performed with clinical specimens.

Reproducibility and consistency are critical to pursue the research goals and bring projects to completion. The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as 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.

All required documents must be submitted via the NIAID electronic Simplified Acquisition Submission System (eSASS) website at https://esass.nih.gov by May 6, 2025 at 5:00 pm ET. All vendors must register in the eSASS system to submit their documentation. Instructions on how to register /submit documents are included on the website. 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.