01-21271. Opportunity To Collaborate in the Evaluation of Rapid Diagnostic Tests for Syphilis

AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS).

ACTION:

Opportunities for collaboration for evaluation of rapid diagnostic tests for syphilis. The Centers for Disease Control and Prevention (CDC), National Center for HIV, STD, and TB Prevention (NCHSTP), Division of STD Prevention, has an opportunity for collaboration to evaluate rapid diagnostic tests for syphilis. These evaluations will include evaluation of the sensitivity in primary, secondary and latent syphilis, and of the specificity of the test.

SUMMARY:

The Division of STD Prevention of the National Center for HIV, STD, and TB Prevention (NCHSTP) at the Centers for Disease Control and Prevention (CDC) of the Department of Health and Human Services (DHHS) seeks one or more companies who have developed or are distributing a rapid diagnostic test for syphilis and are interested in marketing the test for use in the United States. The Division of STD Prevention is interested in evaluating such tests. The evaluation will include determination of the sensitivity in primary, secondary and latent syphilis and of the specificity of the test. This collaboration will have an expected duration of two (2) to three (3) years. The goals of the collaboration include the timely development of data to be used to determine whether the test could be used in the diagnosis of syphilis and/or screening for syphilis in the United States.

Confidential proposals, preferably six pages or less (excluding appendices), are solicited from companies who have a product that is suitable for commercial distribution.

DATES:

Formal proposals must be submitted no later than September 24, 2001.

ADDRESSES:

Formal proposals should be submitted to Candice Nowicki-Lehnherr, Division of STD Prevention, NCHSTP, CDC, 1600 Clifton Road, Mailstop E-05 Atlanta, GA 30333; Phone [phone]; Fax [phone]; e-mail: [e-mail]. Scientific questions should be addressed to Madeline Sutton, MD, Division of STD Prevention, NCHSTP, CDC, 1600 Clifton Road, Mailstop E-05, Atlanta, GA 30333; Phone: [phone]; Fax: [phone]; e-mail [e-mail].

SUPPLEMENTARY INFORMATION

Technology Sought

One mission of the Division of STD Prevention/NCHSTP is to develop and evaluate biomedical interventions to reduce syphilis. To this end, the Surveillance and Epidemiology Branch is seeking rapid diagnostic tests for syphilis that are suitable for commercial distribution and that are simple, tests that can be performed in 30 minutes or less by persons with minimal training.

NCHSTP and Collaborator Responsibilities

The NCHSTP role may include, but will not be limited to, the following:

(1) Providing scientific, and technical expertise needed for the research project;

(2) Planning and conducting research studies of the diagnostic tests and interpreting results; and

(3) Publishing research results.

The NCHSTP anticipates that the role of the successful collaborator(s) will include the following:

(1) Providing tests that can be used in the evaluation; and

(2) Providing NCHSTP access to necessary data in support of the research activities.

Selection Criteria

Proposals submitted for consideration should address, as best as possible and to the extent relevant to the proposal, each of the following:

(1) Data available on the performance of the tests in different stages of syphilis and in the absence of syphilis;

(2) Information on the technology used for the test;

(3) Information on the time required to perform the test, whether the test is preformed on whole blood, sera, plasma or saliva and the steps involved in performing the test; and

(4) Interest by the company to seek FDA approval and market the test in the United States.

Dated: August 17, 2001.

Joseph R. Carter,

Associate Director for Management and Operations, Centers for Disease Control and Prevention.