FoundationOne companion diagnostic FDA approved

Non-Sponsored Content

By: scienterrific | Last updated: 30 November 2017 | In: US FDA Onc\Haem Approvals, Uncategorised

Article Keywords

NGS, FDA, CDx, F1CDx, Foundation Medicine, FoundationOne, IVD

On 30 November 2017, the FDA granted marketing approval for the FoundationOne companion diagnostic (F1CDx®, Foundation Medicine), a next generation sequencing (NGS) based in vitro diagnostic (IVD) to detect genetic mutations in 324 genes and two genomic signatures in any solid tumour.

Disclaimer

This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).

Non-Sponsored Content