Welcome to precisionFDA

Welcome to PrecisionFDA

A community platform for NGS assay evaluation and regulatory science exploration.

The security of precisionFDA users’ personal information and data is of critical importance. In order to further strengthen the safeguards already in place, precisionFDA will be introducing several changes in order to achieve compliance with the FedRAMP and FISMA security standards. Please click here for more information.

Please Note: There will be a service outage between 5pm EST Oct 31 - 5pm EST Nov 1 to upgrade precisionFDA for FISMA compliance.

Expert Spotlight:
Cdrh biothreat updated
FDA ARGOS Team – DoD USAMRIID Collaboration on Biothreat Detection


Heike Sichtig, Ph.D.
FDA

The Ebola outbreak in West Africa in 2014 used advanced infectious disease (ID) detection technology based on next generation sequencing (NGS) to determine index case and potential novel microbes. Current ID-NGS technology is still evolving and typically involves complex laboratory and bioinformatics workflows. The use of NGS provides a biased-free, detailed view of infectious microorganisms that promises to enable faster detection, traceback, and selection of therapeutics without prior knowledge of disease cause. To reach these objectives, ID NGS computational workflows must be independently evaluated and validated. [read more at the full blog]

precisionFDA Challenges
Engage and improve NGS software through community challenges
Latest precisionFDA News
Learn about the latest precisionFDA events and news
Community Participants
Personalis
Seracare
Sequenom
Emory Genetics Lab
Roche
NIH
Broad Institute
DNAnexus
Edico Genome
Macrogen
Human Longevity Inc.
Crystal Genetics
Illumina
23andMe
GeneDx
NIST
White House Office of Science and Technology Policy
American Heart Association
Baylor College of Medicine
Garvan
US House of Representatives
Natera
PharmGKB
Qiagen
Counsyl
Intel
Blueprint Genetics
Centers for Disease Control and Prevention

Dr. Lester Carter
Dr. Euan Ashley
Dr. Teri Klein
Dr. Dennis P. Wall
Rachel Goldfeder
Hans Nelsen
Dr. Russ Altman
Dr. Peter Tonellato
Mark Woon
Dr. Snehit Prabhu
Dr. Mark Wright

The comparison framework uses open-source software by Real Time Genomics
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