There are some great tidbits in this announcement, IMO.
EUA experienced partners and signed distributor agreements!
The same test strip for all fluids? Whoa. Unheard of. Blood plasma, too?!?
Who knew that all our spit was so alike and could be proven to be so in 10.5 seconds?
Awesome, Keith! Go DECN!
EUA experienced partners and signed distributor agreements!
Quote: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 Kitthat 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.
The same test strip for all fluids? Whoa. Unheard of. Blood plasma, too?!?
Quote:The company is now also finalizing the software updates and algorithms for its GenViro! Swift Kit testing meters that will test (read) the saliva provided by a human donor. No changes were required to the GenViro! test strip which has the capability to work with whole blood, blood plasma and saliva.[color]
Who knew that all our spit was so alike and could be proven to be so in 10.5 seconds?
Quote:
"We will also seek to share some testing data as it becomes available from our Korean partners. Right now we are reviewing exceptional accuracy in our testing as well as reproducibility, with impedance values across the entire spectrum of human donors showing less than a 5% variance. Our Korean partners' tests of known negative patients has exceeded what the FDA guidance states. While this is the first such data to come in, GenViro! is operating at a level well above what is currently required by the FDA and beyond what experts such as Harvard's Dr. Michael Mina are saying should be necessary for simple, rapid testing that he says, ‘provides the transmission indicator testing needed'. We expect additional data to arrive shortly," said Berman.
Awesome, Keith! Go DECN!
