Self-Sampling Devices for HPV-Testing-Based Cervical Cancer Screening

Fast-Track proposals will be accepted. Direct-to-Phase II proposals will be accepted Number of anticipated awards: 3 - 5 Budget (total costs, per award): Phase I: up to $400,000 for up to 9 months Phase II: up to $2,000,000 for up to 2 years PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED. Summary All currently recommended screening tests for cervical cancer require a clinic visit and a clinical provider (physician/nurse practitioner/physician assistant)-conducted per-speculum examination for sample collection for the screening method (HPV testing and/or Pap smear cytology). An alternative that has been explored is self-collection of samples (‘self-sampling’) by women themselves for HPV testing, an approach that offers several benefits including ease of collection at a time/place of women’s choosing and without a need for appointment or speculum examination. However, most current sampling devices have not incorporated consumer-friendly/user-centric design principles; therefore, it has been challenging to demonstrate acceptable accuracy given the variations in collection type and the expected decrement in yield of cellular material when performing self-sampling versus a clinician-collected sample from the cervix directly. Therefore, there exists a significant need for development and evaluation of novel devices for self-collection. The proposed contract topic solicitates the development and evaluation of novel self-collection devices, including activities leading to manufacturing and regulatory approval. Project Goals The overall goal of the contract solicitation is to facilitate the commercial development and regulatory approval pathway for novel self-sampling devices for HPV-testing-based cervical cancer screening. In particular, companies are expected to propose designing and manufacturing of devices for self-collection and transport/storage of cervicovaginal specimens and to demonstrate their clinical accuracy with a goal to seek FDA clearance via the 510(K) pathway (substantial equivalence with a predicate device for safety and efficacy; NCI will provide access to the predicate device that is being evaluated in an ongoing trial). The type of novel self-sampling devices that fall within the scope of this solicitation can be, but not be limited to, cytobrush-like, broom-like, or tampon-like devices and when applicable may include the following accessories: (i) Transport media (e.g., dry-swab, paper-based, fluid-based), independent or in conjunction with the collection devices, and (ii) shipment protection (with or without the transport media) to prevent contamination and maintain sample integrity during transport. Please note that technologies that involve collection approaches that are designed to be performed without patient participation are NOT considered appropriate for development under this contract topic. Phase I Activities and Deliverables: Offers must propose to conduct activities that lead to development of a working prototype device ready for clinical evaluation, including but not limited to: • Using user-centric design principles, develop the prototype self-sampling device, transport media and shipment kits for evaluation. • Conduct studies to establish analytical performance (analytical sensitivity, specificity) and other performance characteristics (e.g., limit of detection, consistency, reproducibility). • Conduct studies to evaluate and test user acceptability and feasibility in both intended use populations (i.e., women who are likely to miss regular cervical cancer screening and may therefore be appropriate candidates for home-based self-sampling) as well as average-risk populations. • Conduct initial clinical testing with at least one of the current FDA-approved HPV testing assays to determine the clinical performance measures (e.g., concordance with clinician-collected sample, clinical sensitivity and specificity). • Offerors may need to establish a collaboration or partnership with a research group or medical facility that can provide relevant patient access; offerors must provide a letter of support from the partnering organization(s) in the proposal. Phase II Activities and Deliverables: Offerors must propose activities leading to the manufacturing and regulatory approval of the device, including but not limited to: • Develop a well-defined self-sampling device under good laboratory practices (GLP) and/or good manufacturing practices (GMP). • Perform manufacturing scale-up and production for multi-site and multi-test evaluations • Demonstrate the clinical sensitivity and specificity of the device for self-sampling by performing multi-site and multi-test evaluations • Establish a strategy for FDA regulatory approval and insurance and/or CMS reimbursement