Will DECN use testing results from Korea to apply for the CE Mark? Or, will DECN use the results from one of the U.S. testing labs to apply for CE?
The above comes from the latest PR...
Quote:As discussed previously, the GenViro! Swift Kit will be tested in two phases; the first phase providing results to assist the company in seeking approval in the EU, Russian Federation and the ten other nations where we have signed distributor agreements. The second phase testing will be for the FDA EUA authorization.
The above comes from the latest PR...
Quote:"As the experts have pointed out, the country needs to change its testing platform in order to identify people when they are most infectious, and while at the same time potentially being asymptomatic, and that's what our Genviro! Saliva testing products are designed to do," says DECN CEO Keith Berman. "Important advancements have been made toward selecting a lab, or perhaps two labs, to do our US-based testing on our saliva methodology that we believe should be more readily accepted by the FDA, and eventually by individuals for at-home use as it is completely non-invasive. We have engaged a special consultant to expedite this process, and as a result he recently introduced us to a third laboratory located on the east coast. Our decision is now between two laboratories associated with major university hospitals and a third reference laboratory currently involved in its own (non-competitive) EUA in process. All three laboratories deal with saliva based methods. The two laboratories associated with university hospitals already have approved EUAs through the FDA. However, none of these laboratories offer methodologies that provide results as expeditiously as our GenViro! Swift Kit that has recorded lab test results in (10.5 seconds), and, even more significantly, offer true point of care testing. As discussed previously, the GenViro! Swift Kit will be tested in two phases; the first phase providing results to assist the company in seeking approval in the EU, Russian Federation and the ten other nations where we have signed distributor agreements. The second phase testing will be for the FDA EUA authorization.
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