The U.S. Food and Drug Adminstration(FDA) hereby issues this notice of intent to award a sole source order to BioGx, Inc., located at 1500 1st Ave North Suite L-123, Birmingham, AL 35203-0000, to obtain 125 Lyophilized E.Coli Polymerase Chain Reaction (PCR) Bead Kits sold under Product Item Number BioGX 202-0004 (Cepheid 900-0004). BioGX, Inc. is the only known source which can provide the required bead kits. The procedure for PCR amplification E. coli O157:H7 (which is outlined in the FERN-MIC-0003.00) requires the use of lyophilized beads containing specific primers and reagents. See the attached document for more detailed specifications on the bead kits. The beads are not made by any other manufacturer. These beads are only produced by BioGX inc. in partnership with Cepheid. They are produced specifically for the Food Emergency Response Network (FERN) for the analysis of E. coli O157:H7 in regulated products. BioGX is the sole producer of these unique kits and accessories.

The NAICS Code is 541711 Research and Development in Biotechnology.  This procurement will be conducted under the authority of FAR 6.302-1, only one responsible source and no other supplies or services will satisfy agency requirements. Authority: 41 U.S.C. 253(c)(1).

This notice is not a request for competitive quotes; no solicitation document is available and telephone requests will not be accepted. However, sources may submit descriptive literature, fully documenting their capability to perform these services within the timeframes needed, which will be considered by the agency. A determination to compete this procurement based on response(s) to this notice is solely within the discretion of the Government. It is anticipated that award may be issued to  within approximately 15 days after the date of this notice unless the Government determines that any other organization has the capability to meet this requirement. All responses must be received no later than 3:00 PM Eastern Time on July 8, 2010 to the attention of Jennifer Eskandari at [email protected].

Bid Protests Not Available