The United States Food and Drug Administration (FDA) in its attempts to play catchup to a new breed of genomics based companies and the burst of genomics tests, is setting up a new platform called precisionFDA in partnership with DNAnexus.
Defined as a new approach of regulating and evaluating bioinformatics workflows, precisionFDA will help FDA to better understand and validate next-generation DNA based diagnostic tests. Reference diagnostic datasets sources (reference genomes) around NGS analytical tests will be build using a community of companies, clinics and hospitals. DNAnexus is also hoping to built a community around its platform to aid uniform standards around bioinformatics formats, secondary analysis, gene mapping, alignment and variant calling.
If successful it could change the way genetic diagnostic tests are developed, regulated and evaluated in the United States. According to usaspending.gov, DNAnexus will get upwards of $850,000 to build this community and help FDA step foot into the era of personalised medicine. I would also help the participating companies improve their diagnostic services and gain the confidence of the end users.
FDA was left inadequately informed recently when 23andMe started offering $99 DNA sequencing diagnostic tests. PrecisionFDA will be a vital tool to handle tests offered by 23andMe and similar companies and bring credibility and standardisation to “laboratory developed tests” being offered by their community members. It will also help FDA to make quick regulatory decisions with greater faith in the data and bring them under the same regulatory umbrella that drug and medical device manufacturers are currently under.
The Chief Cloud Officer
CEO of DNAnexus Omar Serang believes that crowdfunded consensus could lead to a larger and better reference genomes and bring reproducibility by comparing and contrasting the results from different labs. Unlike the marketplace of bioinformatics apps, Helix being built by Illumia, this community will help the app providers to offer certain tests. The community members could learn from each other’s findings and mistakes.
FDA and DNAnexus aim to launch a minimalist version of the platform by the end of this year. For the Google Ventures backed DNAnexus, this opportunity gives it a firm footing in NGS diagnostic tests.
Source: DNAnexus Press Release