Study 1315

  • The Client:

Diagnostic Developer

  • The Science:

Head and Neck Cancer samples for imaging

  • The Challenge:

Acting as a core pathology lab to validate samples for FDA submission

  • The Folio Solution:

Folio provided a dedicated team to work one on one with the client.

Based on the client’s needs:

Folio, monitored procurement from 13 US sites
Kits were provided to each site and inventory of kits monitored to ensure proper supplies
Documentation according to client protocol for shipping samples to Folio.
Once the samples were received, the integrity was verified and QC’d by our histologists, then processed in our CLIA lab and evaluated by a board certified pathologist. Folio created and managed an electronic database of records for all sample results. Consistent study report packages were created and sent to the client, which was maintained according to FDA protocol.