Clinical Division Genetic Testing and Next Generation Sequencing Services for Active Clinical Protocols- bone marrow failure syndromes, aplastic anemia, myeloid neoplasms, clonal hematopoiesis, and related hematologic disorders

The National Heart, Lung, and Blood Institute intends to sole-source award clinical genetic testing and next-generation sequencing services to The University of Chicago Medical Center, with responses due September 8, 2026 at 12:00 PM ET. Work supports the Division of Intramural Research's active clinical protocols addressing bone marrow failure syndromes, aplastic anemia, myeloid neoplasms, clonal hematopoiesis, and related hematologic disorders across approximately 160 active clinical protocols, roughly 30 percent involving Investigational New Drug or Investigational Device Exception approvals.

The contractor must deliver a validated next-generation sequencing assay analyzing approximately 111 genes associated with hematologic malignancies and inherited bone marrow failure syndromes. Minimum requirements include complete sequence analysis of coding regions; analysis of 5' untranslated regions for ANKRD26, DKC1, TERC, and TERT; coverage of all coding exons and flanking intronic sequences; target enrichment using validated capture technologies; Illumina or equivalent sequencing technology with paired-end sequencing capability; validated bioinformatics analysis; supplemental Sanger sequencing confirmation; and clinical reports identifying pathogenic and likely pathogenic variants per accepted laboratory standards. The contractor must maintain all applicable clinical laboratory certifications and accreditations.

Work is performed at the University of Chicago Genetics Services Laboratory, 5841 S. Maryland Ave., Room G701, Chicago, Illinois 60637. Period of performance consists of one base year plus four one-year option years. The contractor provides specimen collection kits, prepaid shipping, specimen processing, quality control and assurance, secure electronic reporting, and technical consultation. The sole-source justification emphasizes that The University of Chicago is the only institution capable of providing the required 111-gene panel with necessary comprehensiveness and analytical continuity; transitioning alternatives would introduce unmitigated risks to patient safety and research integrity due to technical variance in variant-calling and loss of longitudinal data comparability.

Interested parties must submit responses to noelle.decenzo@nih.gov referencing solicitation number 75N98026Q01002, including unit pricing, list price, shipping costs, delivery period, payment terms, F.O.B. point, UEI, TIN, and business size certification. All offerors must maintain active SAM registration. The acquisition is conducted under FAR Subpart 12.102(a) as a commercial purchase. NAICS is 622110 (General Medical and Surgical Hospitals) with a $47 million small business size standard.