HLA Genotyping Assays for Transfusion Medicine

The National Institutes of Health (NIH) intends to award a fixed priced purchase order on a sole source basis to Omixon Inc. Salem, MA, 01970 to procure thirty (30) New Generation Sequencing (NGS)-based HLA Genotyping Assay, Holotype HLATM 24/11 - Configuration A1 v2 for the existing government owned Illumina® MiSeq instrument, and thirty-four (34) Amplification kit Q250. This instrumentation is used by Department of Transfusion Medicine, Human Leukocyte Antigen (HLA) Lab to determine the HLA type of a patient or donor. The specified reagents are necessary to perform the highest resolution typing possible for HLA testing which is necessary for the workup of mismatched transplants performed at NIH via the unrelated and haploidentical transplant protocols. The Holotype HLATM provides targeted amplification and library preparation reagents for comprehensive gene coverage of multiple HLA loci and the most accurate, high resolution genotying available, with no reflexive testing required.

These reagents are the only kits known which are currently available in the United States utilizing the technology that the NIH HLA laboratory deems essential to employ, including preparatory steps to achieve the final product.Omixon is the sole licensor of the product. Training in the use of Omixon's products is exclusively provided by Omixon, a designated reference lab, Agent or Distributor. Omixon's products are all protected trade secrets. There are no potential substitutes.This acquisition is being conducted under the authority of the FAR Subpart 13.106-1(b)(i), Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available. Interested concerns capable of providing the same or similar products or services as described in this notice may submit a capability statement outlining their capabilities. Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. A determination to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. The total dollar value of this purchase order shall not exceed $150,000.00.Each response should include the following Business Information:a. DUNS.b. Company Name, address, POC, Phone and Email addressc. Current GSA Schedules or NAICS codes appropriate to this Award.d. Type of Company (i.e., small business, 8(a), woman owned, hubZone, veteran owned, etc.) as validated in System For Award Management (SAM). All offerors must register on the SAM located at http://www.sam.gov/portal/SAM/#1e. Capability StatementComments to this announcement may be submitted to the Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Malinda Dehner, Contract Specialist, dehnerm@cc.nih.gov by the due date and time marked in this notice.Contact Information: Malinda Dehner, Lead Contract Specialist, Phone 301-594-6320, Email dehnerm@cc.nih.gov - Barbara Taylor, Contracting Officer, Phone 301-594-5915, Email Barbara_Taylor@nih.gov Office Address :6707 Democracy Blvd, Suite 106, MSC 5480 Bethesda MD 20892-5480 Location: Clinical Center/Office of Purchasing & Contracts Set Aside: N/A