Oversight of Laboratory Developed Tests: Impact on Genomics
What is a laboratory developed test?
A type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory. They include a wide variety of analytes. This includes DNA which can be used to help diagnose a genetic disease or predisposition to disease
FDA Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories - Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs),
[PDF 312.49 KB]
October 1, 2014
FDA draft LDT guidances to be available for public comment Oct. 3,
Genome Web, Oct 1 [by free subscription only]
Big changes for molecular diagnostics as FDA moves on lab developed tests,
by Aaron Krol, Bio IT World, Sep 23
Regulatory changes raise troubling questions for genomic testing![External Web Site Icon External Web Site Icon](https://lh3.googleusercontent.com/blogger_img_proxy/AEn0k_v3cIWXmdKNZcprEpZcaRt3r76_tygEW3QcbjbyD96VNB-BWM-jt6903EobvLmlakeCVbdPZqCtYhroAj5NPxafr5LZh4Iv84T2UT3ZbfaaCDhYoJeNeqjC=s0-d)
Barbara J. Evans, et al. Genet Med advance, September 25, 2014
Barbara J. Evans, et al. Genet Med advance, September 25, 2014
FDA takes steps to help ensure the reliability of certain diagnostic tests. Reinforces agency’s commitment to fostering personalized medicine,
FDA, Jul 31
Regulation of genetic tests,
information from the National Human Genome Research Institute
No hay comentarios:
Publicar un comentario