Inactive
Notice ID:23-009927
Title Oncogene mutation sequencing assay for the Department of Transfusion Medicine of the NIH Clinical Center Product Service Code: 6640 NAICS Code: 334516 Place of Performance: Bethesda, MD 20892 US...
Title Oncogene mutation sequencing assay for the Department of Transfusion Medicine of the NIH Clinical Center Product Service Code: 6640 NAICS Code: 334516 Place of Performance: Bethesda, MD 20892 USA POTS: 23-009927 Description 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. The National Institutes of Health (NIH) intends to award a fixed price contract on a sole source basis to Q Squared Solutions Expression Analysis LLC of Durham, North Carolina 27703 to procure an oncogene mutation sequencing assay. The test confirms that the stem cells used in the cell therapy project to differentiate retinal pigment epithelium cells for the transplantation purposes don’t have any cancer-related mutations, and that the clinical product is safe to be transplanted in the patient. Using the technology of gene sequencing, the vendor performs analysis to determine cancer-related mutations in the induced pluripotent stem cells derived from patient’s blood cells. The proposed vendor, Q Squared Solutions Expression Analysis LLC is the sole manufacturer of the oncogene sequencing assay and they are already deemed a qualified vendor by the FDA. In addition, the vendor has a proprietary database for sequencing and analyzing a panel of 523 oncogenes in a CLIA certified laboratory. 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 Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Shasheshe Goolsby, Lead Contract Specialist, shasheshe.goolsby@nih.gov by August 11, 2023 1:00PM EST. *** Please send your capability statements ONLY. This IS NOT a request for proposal. ***
