R&D Mycoplasma PCR testing

This is a notice of intent to award a sole-source purchase order and is not a request for competitive proposals. The National Center for Emerging and Zoonotice Infectious Diseases (NCEZID), intends to solicit and enter into a contract with Bionique Testing, Saranac Lake, NY 12983. The contractor shall furnish the require rapid rt-PCR testing platform for consistent determination of low levels of Mycoplasma contaminants (1-10 genomic copies), generation of growth curves by enrichment for sensitivity, and pan-species detection for the dozens of Mycoplasma species that could contaminate our 25 mammalian cell culture lines in weekly production and hybridoma lines that have never been tested previously. This PCR technology should replace time-consuming, subjective in-house testing with consistency and certificates of analysis. The contractor shall test 8-12 samples per month for at least 5 independent cell lines and 3-7 individual hybridomas. Testing turnaround should be 4-5 days and require controls to insure proper PCR sensitivity which should include: Spike Recovery Control, Positive Extraction Control Negative Extraction Control, Inhibition Control and Negative PCR Control. This would fulfill the cell culture and hybridoma quality control requirements of the National Center for Emerging Infectious Diseases (NCEZID), Division of Scientific Resources (DSR) in the Office of Infectious Diseases, Center for Disease Control and Prevention. All cell lines shall be tested as indicated and in a manner according to parameters set forth in PCR specifics. They are the only manufacturer on the market that can meet the PCR technology that met the rigorous standards for the program. Bionique PCR technology fulfills the cell cultures and hybridoma needs of DSR and growing list of projects developed from CDC SMEs. The Government intends to solicit, negotiate and award to only one contractor using other than full and open competition procedures pursuant to the authority of FAR 13.106-1(b)(1). The NAICS code for this acquisition is 811219 and the small business size standard is 500 employees. This requirement will be procured under the guidelines of FAR Part 12, Commercial Items. Award will be made using Simplified Acquisition Procedures, FAR Part 13. Interested parties should submit a capabilities statement demonstrating their ability to provide the required system to Deborah T. Workman by email at contact@example.gov. This notice of intent is not a request for competitive proposals; however, the Government shall consider all responses received. A determination by the CDC not to compete this proposed contract, based upon responses to us notification, is solely within the discretion of the Contracting Officer.