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Agendia to Provide Testimony at Public Meeting on FDA Oversight of Laboratory-Developed Tests
Date:7/15/2010

LDT category in a uniform and unbiased manner to ensure that all claims are validated, data is accurate and post-market surveillance is in place. Moreover, Agendia believes that holding the LDT category to the rigors of FDA scrutiny will inspire greater confidence among investors to enter this emerging market, foster a level playing field among molecular diagnostics companies and encourage the best technology to come to the fore in personalized medicine.

As the developer of the first and only FDA-cleared breast cancer recurrence test, MammaPrint, Agendia has led by example in the molecular diagnostics industry by embarking on a path of regulatory compliance. Agendia believes that patients and physicians deserve to be fully informed about the benefits and risks of medical diagnostics, and that all companies developing these devices should be held accountable for the claims and safety of their tests.

The FDA will collect and review all comments and information presented at this public meeting towards the development of a draft oversight framework for public comment. The meeting will be held on July 19 (8:00 a.m. to 5:00 p.m.) and July 20 (8:00 a.m. to 5:30 p.m.) at The Marriott Inn and Conference Center, University of Maryland University College.


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