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Posted On: 03/21/2020 2:21:05 PM
Post# of 11802
From PR on 3/16 "GenViro!™ has been validated at the company's R&D center in Daegu, Korea for the H5N1 virus and most recently the methodologically similar corona virus. "
This states the GenViro! Assay is validated and per the 3/16 FDA Guidance, DECN can begin marketing and selling the test prior to EUA approval from FDA. So the kit isn't being created, it's now most likely being manufactured. Big difference.
Per FDA Guidance, DECN wouldve submitted EUA application within 15 days of notifying FDA of test validation.
Once this FDA guidance was interpreted in the context of how quickly they could get a product to market, combined with the fact that Covid was validated on their GenViro! Test which uses the same impedence technology as their glucometer which is FDA approved, they decided to secure funding ASAP.
They have a test validation, FDAs desire to rapidly bring tests to market, a technology that FDA has previously approved for another indication, manufacturing capability, demand, many suitors for licensing, partnering and distribution.
This states the GenViro! Assay is validated and per the 3/16 FDA Guidance, DECN can begin marketing and selling the test prior to EUA approval from FDA. So the kit isn't being created, it's now most likely being manufactured. Big difference.
Per FDA Guidance, DECN wouldve submitted EUA application within 15 days of notifying FDA of test validation.
Once this FDA guidance was interpreted in the context of how quickly they could get a product to market, combined with the fact that Covid was validated on their GenViro! Test which uses the same impedence technology as their glucometer which is FDA approved, they decided to secure funding ASAP.
They have a test validation, FDAs desire to rapidly bring tests to market, a technology that FDA has previously approved for another indication, manufacturing capability, demand, many suitors for licensing, partnering and distribution.
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