3 Experts Comment to FDA on MCED

 https://media.licdn.com/dms/document/media/D561FAQEWoC8S1Dy1xQ/feedshare-document-pdf-analyzed/0/1705445993154?e=1706745600&v=beta&t=-hTnTSekCyauz-qETg06MTVIikLUZVlZEAK6xJxr4Zk

https://www.linkedin.com/posts/girish-putcha-md-phd-b052524_public-comments-to-fda-re-mcd-tests-ugcPost-7153159302596190208-yaRr?utm_source=share&utm_medium=member_ios

The letter addresses the design and evaluation of multi-cancer detection (MCD) tests, focusing on their validation, safety, and effectiveness. The authors emphasize the need for thorough clinical validation in the intended use population, caution against relying solely on short-term endpoints, and highlight the insufficiency of aggregate clinical performance measures. They stress the importance of tissue-of-origin information in MCD tests and advocate for rigorous, scientifically sound regulatory frameworks. The letter also suggests hosting a workshop for further discussion on these complex topics.

Key points from the letter include:

1. Clinical validation for MCD tests should be performed in the intended use population.
2. Reliance on surrogate short-term endpoints is inadequate for demonstrating the benefits of MCD tests.
3. Aggregate measures of clinical performance can be misleading for MCD tests.
4. Tissue-of-origin information should be a mandatory component of MCD tests.
5. Long-term outcomes must be assessed in randomized controlled trials for MCD tests.
6. Specific subgroup analyses are necessary for different risk groups in MCD test studies.
7. The need for transparent, consistent, scientifically rigorous, and least burdensome regulatory frameworks.
8. Suggestion to host a workshop to address detailed aspects of MCD test development and evaluation.
9. Consideration of the challenges posed by different natural histories, molecular pathophysiologies, and care pathways of cancers.
10. Emphasis on the importance of demonstrating safety and effectiveness in the intended use population before market authorization.