What I need from the FDA as an Entrepreneur

Dear FDA,

I need a path that allows genetic information to ENTER the marketplace.

I'd like for anyone planning on commercializing genetic information to be able to submit their interpretation and receive an identifier for their submission along with a rating in three areas:

Medical Utility (the 5 star rating system commonly seen for the web) .

Quality of Science (graded the same as school, A thru F with I for incomplete and W for withdrawn).

Viewing Risk (graded same as for motion pictures E, PG, R, X and NR). We can treate PG as physician guidance recommended and require certification for R and X rated information access.

Here’s an example: FDA Genetic Interpretation Test ID: FDAgi001

Medical Utility: 4.5 Stars
Quality of Science: B+
Viewing Risk: PG (Physician Guidance recommended)

Approval for a molecular diagnostic could then be dynamic and progressive - allowing for works in progress to move through the marketplace (and/or be kicked out). Entrepreneurs could build applications that applied whatever rules an organization wanted regarding reimbursement or patient engagement. The whole process of evaluating the interpretation of a persons genome could become more transparent, timely and hopefully affordable.

We want to be able to provide incremental improvements in the interpretation of a persons genome to the global marketplace in near real time.

Sincerely,

Alice Rathjen