Evaluation of the Relationship Between Phenotypic and Molecular Measures

Sole Source Award Notice: Jones Microbiology Institute, Inc. The purpose of this procurement is to develop an unambiguous, comprehensive model that can allow for the mapping and classifying the evidence of the relationship between molecular (genotype) mechanism of resistance and the resistance phenotype for clinically relevant human bacterial pathogens. There is a major need to capture existing knowledge about the resistance phenotype (accumulated through many years and form clinical drug studies) and the molecular detection to make the results of an in vitro diagnostic device “actionable” when reporting results in the same manner as a current phenotypic-based antimicrobial susceptibility test methods; this can only be accomplished by a ‘living’ database, one that FDA, sponsors, and clinicians can use for regulatory and clinical practice. A notice of intent is issued a sole source to Jones Microbiology Institute, Inc. with authority of the FAR Part 12.603 (c)(2)(i), this is a combined synopsis/solicitation for commercial items prepared in accordance with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. and If there are no responses have received in response to the posting. Therefore, it was determined that no other sources are capable and willing to develop an unambiguous, comprehensive model that can allow for the mapping and classifying the evidence of the relationship between molecular (genotype) mechanism of resistance and the resistance phenotype for clinically relevant human bacterial pathogens to Center for Devices and Radiological Health/Office of In Vitro Diagnostics and Radiological Health. Estimated Value: $85,000.00 for a base year. In accordance with FAR Part 13.106-1(b), the Contracting Officer may solicit from one source if the Contracting Officer determines that the circumstances of the contract action deem only one source reasonably available. For the reasons stated above, Jones Microbiology Institute, Inc. is the only source considered in this procurement.