Intent to Sole Source to Vela Diagnostics USA Inc.

The government proposes to make an award to Vela Diagnostics USA Inc to procure reagents and consumables to fulfill the test service requirement for Sentosa SQ HIV-1 Genotyping Assay, which is the only FDA approved NGS assay for HIV drug resistance (HIVDR) detection. These reagents, include all kits for sample extraction, PCR amplification, library preparation and purification, sample barcoding, normalization, and sequencing, which is a package specifically designed and developed for conducting the NGS HIVDR genotyping testing procedures. Conducting the HIVDR genotyping test is a core lab activity in supporting the global HIV drug resistance surveillance in PEPFAR supported countries. While using these specific reagents from Vela Diagnostics in testing services is required to maintain the integrity of FDA label and mandatory to achieve the quality standard in accordance with the accreditation requirements of International Organization for Standardization (ISO) and the College of American Pathologists (CAP).This notice of intent is not a request for competitive quotations; however, all quotations/responses received within fifteen (15) days of the issuance of this notice will be considered by the government. A determination by the government not to compete this proposed contract based upon 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. Any quotation/response should be emailed to contract specialist at uid1@cdc.gov by COB June 14,