This request is for a Cepheid GenExpert System for the detection of C. trachomatis, N. gonorrhoeae and other sexually transmitted infections. Cepheid is the developer, manufacturer and sole vendor for the GenExpert System.

This is a new test system for the detection of C. trachomatis and N. gonorrhoeae. The system has user flexibility allowing for additional organisms to be included as needed. It is a moderately complex system which is ideal for outreach programs for the diagnosis of these infections.

This is an enclosed nucleic acid amplification assay that is unique to other assays that are based on open amplification. For this reason, the GenExpert is moderately complex while others are highly complex as categorized by CLIA. This categorization allows for greater expansion of testing in laboratories that are not certified for highly complex testing assays. CDC requests this assay for comparative studies with laboratories that are moderately complex and/or outreach programs. There are no other assays available to meet these conditions. All other nucleic acid amplification assays currently on the market are classified by CLIA as highly complex because of their technology and operator expertise requirements. This prohibits our field partners (states, territories and some global) from using nucleic acid diagnostics. GenExpert is CLIA designated "moderately complex". The closed system protects against contamination. The low power requirement and small footprint make it appropriate for more field operation. Thus GenExpert can be used in our partner labs if we can do the comparative studies to validate their results. This expands our partnership role with these labs. In addition, the ability to modify specimen target enhances CDC's ability to expand the test menu to meet specific program needs for assessing different disease causing organisms.

It is the understanding of the Government that an award to any other source would cause unacceptable delays in meeting the requirements of the Government. Interested parties who feel that they possess the capabilities to provide the services described above should submit a capability statement demonstrating their abilities to provide the services. The information received in response to this notice will be considered solely for the purpose of determining whether or not to conduct a competitive requirement. Please send your documentation to Deborah Workman by fax (770) 488-2868, or email to [email protected]. Documentation should be received within fifteen (15) days after the date of publication of this synopsis to be considered by CDC. A determination by the CDC not to compete this proposed contract, based upon responses to this notification, is solely within discretion of the government.