Access to Specimens for Testing
De-identified clinical specimens for testsing POC devices are available to companies with working prototypes. Device subsystems need not be fully integrated, though a plan for full integration should be available.
Details and Requirements:
- A Non-Disclosure Agreement and a Material Transfer Agreement will be required following an assessment of testing and recommendation for samples approved by the Center Director or her/his designee.
- Organizations needing access to proof of concept for clinical samples for early stage sample preparation technologies or late stage verification of detection technologies may receive up to 10 archival samples for free with application for Center support. More samples as required for validation and/or optimization will be provided at a low cost under the Center’s Institutional Review Board approved Exempt Research protocol.
- Samples which cannot be provided from archival samples due to limitations of the technology may be provided at low cost if allowed under the current IRB-approved protocol.
- More extensive sampling, which would require a new IRB-approved protocol, is beyond the scope of Center funding but samples may be provided under another funding mechanism such as a SBIR award.
- A limit of 100 samples will be instituted for each organization’s development process.
- All organizations must provide a report of the distribution and/or destruction of specimens and results obtained. Unused samples remaining after 12 months must be returned to the Center or destroyed.
- Additional samples may be made available based on proof of progress provided by the organization to Center Director and staff for evaluation.
- Data generated from these studies will be the property of the participating organization, however, the Center will be included in any open source publication of these data.
- Data generated will be required to be included in any limited distribution formal government documents as required by Federal Acquisition Regulation (FAR) standards. These will include but are not limited to final reports required at the conclusion of IRB approved studies and annual or final FOUO reports to government sponsors.