Notice of Intent to Sole Source - Development and Validation of Diagnostic Methods for Coccidioidomycosis (Valley Fever)

Statement of Work / Performance Work Statement Title: Development and Validation of Diagnostic Methods for Coccidioidomycosis (Valley Fever) Period of performance of this contract is: September 30, 2026, to September 29, 2027 SECTION 1 – BACKGROUND Coccidioidomycosis (Valley Fever) is a significant public health concern in endemic regions of the United States and poses risks to both residents and travelers. Current diagnostic approaches are limited by delayed testing, reliance on centralized laboratories, and lack of tools to identify prior infection. These limitations contribute to misdiagnosis, delayed diagnosis, under-detection, and challenges in treatment and clinical management. Existing diagnostic methods are insufficient to support rapid clinical decision-making or to identify individuals with prior infection who may be at risk for disease reactivation, particularly among immunocompromised populations. There is a critical need for improved diagnostic tools, including rapid serologic assays and methods to detect prior infection. The Valley Fever Center for Excellence (VFCE) maintains an established biospecimen repository derived from patients with coccidioidomycosis. This existing resource provides a unique and critical foundation for diagnostic development. However, additional specimen collection and enhanced storage capacity are required to support expanded research and validation activities. This requirement supports the CDC Mycotic Diseases Branch (MDB) mission by leveraging and expanding existing resources to advance diagnostic capabilities for coccidioidomycosis. SECTION 2 – PURPOSE/OBJECTIVE The purpose of this acquisition is to support the development, evaluation, and validation of diagnostic methods for coccidioidomycosis through collaboration with the Valley Fever Center for Excellence (VFCE). This project will leverage VFCE’s existing biospecimen repository and clinical infrastructure to support diagnostic assay development. Additional specimen collection and enhanced storage capacity will be implemented to support expanded research needs. Specific objectives include: • Expansion and utilization of an existing biospecimen repository • Development and evaluation of improved serologic diagnostic methods • Development and analytic validation of a laboratory method to detect prior infection • Generation of data to support future clinical and public health applications Performance objectives include successful specimen collection and characterization, development of prototype assays, and production of validated laboratory procedures suitable for CLIA-compliant environments. Operating constraints include adherence to applicable regulatory standards (e.g., CLIA), use of approved protocols, and coordination with clinical and laboratory partners. SECTION 3 – SCOPE OF WORK The scope of work includes leveraging and expanding an existing biospecimen repository, conducting additional patient recruitment and specimen collection, supporting specimen storage and management, and performing laboratory-based assay development and validation activities. The contractor shall utilize existing infrastructure and enhance it as needed to support project objectives, including procurement of additional storage capacity and collection of supplemental biospecimens. Work shall include development and evaluation of serologic assays and validation of laboratory methods to detect prior infection. -- 1 of 16 -- This effort is limited to research, development, and validation activities and does not include large-scale commercialization or deployment of diagnostic products. SECTION 4 – TASKS TO BE PERFORMED Task 1: Biospecimen Repository Utilization and Expansion 1. The contractor shall utilize an existing biospecimen repository containing clinical specimens from patients with coccidioidomycosis. 2. The contractor shall expand the repository to support project objectives by: a. Recruiting and enrolling additional patients under approved IRB protocols b. Collecting, processing, and storing additional blood and urine specimens c. Maintaining a de-identified inventory of specimens 3. The contractor shall ensure that sufficient specimen volume and diversity are available to support assay development and validation activities. 4. The contractor shall procure and implement additional storage capacity, including the acquisition of a dedicated laboratory freezer, to support storage and organization of specimens used for this project. 5. The contractor shall manage specimen storage and retrieval in a manner that supports efficient use of specimens for research and diagnostic development. Task 2: Development and Evaluation of Serologic Diagnostic Methods 1. The contractor shall receive human subjects review and IRB approval of this task, if applicable, prior to beginning development of diagnostic assays. 2. The contractor shall develop and evaluate serologic assays for detection of early coccidioidomycosis infection. 3. The contractor shall: a. Produce recombinant antigen components (e.g., CTS1 fragments) b. Develop a prototype ELISA assay c. Evaluate assay performance using clinical specimens from the biobank 4. The contractor shall assess sensitivity and specificity of the assay relative to existing diagnostic methods. 5. The contractor shall document findings and provide data to support feasibility of future point-of-care diagnostic development. Task 3: Development and Validation of Assay for Prior Infection 1. The contractor shall receive human subjects review and IRB approval of this task, if applicable, prior to beginning development of diagnostic assays. 2. The contractor shall develop and validate a laboratory method to detect prior coccidioidomycosis infection. 3. The contractor shall: a. Utilize PBMC-based stimulation assays with appropriate antigens b. Conduct laboratory analyses (e.g., flow cytometry-based detection methods) c. Evaluate assay performance for sensitivity to prior infection 4. The contra…