Details after the break.
The Pre Submission Web Page is titled Document M00117 and this discussion is based on V1, released in 4/2015. MolDX writes:
Due to multiple requests for assistance with Technical Assessments (TA), the MolDX Team is pleased to announce the development of the Pre-Submission Review Process. This new process offers developers the opportunity to receive feedback on dossier materials prior to a TA submission.
Although the Pre-submission Process does NOT affect the requirements or review timeline for a TA, the Team hopes the information obtained through the Pre-submission Review will be used to prepare a comprehensive TA submission package and reduce unsuccessful TA submissions.
To request a Pre-submission Review, please follow the steps outlined in the instruction document (M00113), complete the form (M00114), collect appropriate reference and study material per the instructions and submit your request.
Document M00113: "Pre-Submission Review Instructions [V1]"
M00113 is a very brief PDF providing a few instructional steps. M00113 advises that "this option was developed to provide guidance on registered tests [eg with Z code] prior to a Technology Assessments [TA]." Tests must be registered at the McKesson Diagnostics Exchange [DEX] and receive a Z code identifier. Pre-SubmissionGuidance Form M00114 must be filled out, with "relevant published study material, if available." Meetings will be considered with "valid requests" and "availability of subject matter experts."
Document M00114: "Pre-Submission Guidance Form [V1]"
This form is quite similar to the tabular technology assessment that is submitted with full final coverage requests or for NGS tests. Row by row, the table requests summary information on accuracy, limits of detection, precision (e.g. inter run), clinical validation, and clinical utility. Note: Palmetto does NOT require that applicants feel obligated to fill this out literally as a table; it may be more legible as a Word document following each section as described.
Current link to MolDX Home Page here, Technology Assessment website here, and to M00117 webpage here.
Current links to PDF M00113 are here, and PDF M00114 here.
Compare the MolDX approach to a recent FDA publication on bringing payers and regulators together with companies in the pre-regulatory review process, here.
Short URL for THIS webpage: http://tinyurl.com/moldxpresub