Notice of Intent to Sole Source – BIONANO GENOMICS, INC NOI-CC-25-009351

This is a notice of intent, not a request for a quotation. A solicitation document will not be issued and quotations will not be requested. This procurement is for reagents for the Bionano Optical Genome Mapping (OGM) assay for testing samples from patient. Bionano OGM instrument and assay are used to perform optical genome mapping of patient samples to detect chromosomal, cytogenetic, and structural abnormalities that are often missed by other molecular technologies such as cytogenetics, fluorescence in situ hybridization (FISH), or next generation sequencing (NGS). Bionano is the original reagent manufacturer and sole vendor for instruments of these kinds of tests, i.e., optical genome mapping to detect large deletions and cytogenetic abnormalities, copy number abnormalities, and small structural variants from patient samples. It is advisable to use OGM for testing of samples from patients with cancer, cancer predisposing disorders, and with complicated clinical and pathological phenotypes. Furthermore, the instrument obtained from the vendor will be available to other researchers in the Clinical Center and potentially validated for clinical testing purposes. This acquisition is being conducted using policies unique to the Federal Acquisition Regulation (FAR) Part 13 Simplified Acquisition Procedures, Subpart 13.106-1(b)(1), For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. Interested parties may identify their interest and capabilities in response to this posting. The determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government. Comments to this announcement, referencing this posting number, may be submitted to the NIH, Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, to the attention of Ryssa Nix, Contract Specialist via email to Ryssa.nix@nih.gov by close date.