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Oragene Oragene is the trade name for DNA Genotek’s non-invasive DNA self-collection kit. Oragene allows the collection, stabilization and long term storage of DNA from saliva at ambient temperature. Oragene first became available to the genetic research community in 2004. Oragene is available in a variety of formats for various markets. In 2011, Oragene•Dx received 510(k) clearance from the U.S. Food and Drug Administration (FDA).〔Oragene.Dx DNA Collection Device gets FDA Clearance (http://www.medgadget.com/2011/12/oragene-dx-dna-collection-device-gets-fda-clearance.html)〕 ==History== Oragene was invented by Dr. H. Chaim Birnboim. The basis for Oragene is outlined in his 1979 paper which described the widely-used method of alkaline extraction of plasmid DNA from bacteria.〔Birnboim, HC; Doly, J (1979). "A rapid alkaline extraction procedure for screening recombinant plasmid DNA" ''Nucleic Acids Research'' 7 (6): 1513–23. doi:10.1093/nar/7.6.1513. PMC 342324. PMID 388356.〕 For the first time, genetic researchers had access to a mechanism to collect large amounts of high quality DNA through non-invasive sampling. Prior to this discovery, the only option for those with this requirement was to use blood samples. Oragene allows donors to spit into a plastic tube to provide a reliable, high quality DNA sample in a non-invasive way.
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