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PRE-SOLICITATION NOTICE **NOTICE OF INTENT

NOI-NIAID-2170294

NAICS – 541380

This is a Notice of Intent, not a request for proposal. The Laboratory of Immunoregulation (LIR) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis with CD Genomics, DBA CD Biosciences Inc, to procure HPV-related study and analysis genotyping and sequencing services.

This requirement is for microbiome analysis in severe skin and mucosal HPV-related diseases; services for HPV genotyping (210 types) and 19 S rRNA sequencing (V3/V4) for 106 samples respectively. This LIR lab investigates the progression of HPV-related diseases and dysplasia in individuals with primary and acquired immunodeficiencies. The identification of the number and type of infecting HPV variants, their persistence as well as the alteration of the composition of the bacterial microbiome and presence of other coinfecting DNA virus will be investigated longitudinally in a cohort of patients with primary and acquired immunodeficiency. The clinical severity of HPV-related clinical manifestation and the immunological defect identified in the enrolled patients will be correlated with the type and number of HPV variants identified as well as the changes in the bacterial microbiome. As immunodeficiency and HPV infection is necessary but not sufficient to the progression of dysplasia to high-grade or frank invasive squamous cell carcinoma, LIR hypothesized that a proinflammatory microbiome in addition to high prevalence of oncogenic HPV variants will represent a determinant of severe clinical outcomes and high-grade dysplasia. This finding will provide the opportunity to risk stratify the study population and inform optimal clinical management. LIR has already used the services of CD genomics for an initial batch of clinical samples on this study protocol and this is a follow-on for an additional batch that requires the use of the same assays previously utilized in order to maintain consistent and comparable results for HPV genotyping and bacterial microbiome

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 by email (subject line to reference NOI-NIAID-2170294 to Dana Monroe at dana.monroe@nih.gov, by 5:00pm EDST Tuesday, April 18, 2023. 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.