Whole genome and single-nuclei RN sequencing from hemophagocytic lymphohistiocytosis (HLH) and sepsis patients

PRE-SOLICITATION NOTICE ** NOTICE OF INTENT NOI-NIAID-24-2207211 NAICS – 541380, Testing Laboratories 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 SeqMatic, LLC of Fremont, CA, to procure whole genome and single-nuclei RN sequencing from hemophagocytic lymphohistiocytosis (HLH) and sepsis patients.

The Laboratory of Immunoregulation (LIR) continues to be the elucidation of cellular and molecular mechanisms regulating the human immune response in health and disease. A major component of these efforts is the study of the immunopathogenic mechanisms of HIV infection and disease progression.

Within LIR is the HIV Pathogenesis Section (HIVPS) which focuses on immunological, genetic and virological determinants of the susceptibility to severe HPV-related diseases; viral pathogenesis in skin and mucosal surfaces of patients with primary and acquired immunodeficiencies; and immune-based therapeutic strategies of severe HPV-related diseases. The current project involves primary hemophagocytic lymphohistiocytosis (HLH) from perforin deficiency, a rare disease that has not been described in adults.

HIVPS has diagnosed the first adult patient with complete perforin deficiency and their inflammatory syndrome resembled primary HLH in children but with several key differences. Their tissues had massive T-cell infiltration throughout the thymus, spleen, lungs, lymph nodes, and bone marrow.

In order to better characterize the mechanisms of hyperinflammation in this patient, HIVPS plans to perform single-nuclei sequencing of flash frozen tissue from his effected organs (5-samples total) and will compare them to flash frozen tissue samples of a patient with sepsis as a control (3-samples total). Single nuclei sequencing is required as only flash frozen tissue is available and due massive hemophagocytosis at the tissue level would lead to an unacceptable rate of doublets in a single cell suspension.

By evaluating these mechanisms, HIVPS will be able to better characterize mechanisms contributing to HLH in adulthood which could be targeted with future treatments. Since only flash frozen tissue is available from the HLH patient and control sepsis patient, and in the setting of severe hemophagocytosis, a special tissue preparation is required to isolate and fix the nuclei from the tissue.

SeqMatic, LLC has already provided this isolation in combination with the library preparation for single-nuclei sequencing as well as the TCR sequencing and whole genome sequencing of samples and now we are purchasing the whole genome sequencing and the single-nuclei sequencing services for continuation of the same project and continuity within the study. 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 that will be considered by email (subject line to reference NOI-NIAID-24-2207211 to Dana Monroe at dana.monroe@nih.gov, by 5:00 pm eastern standard time January 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.