February 20, 2021:
Newgene-US Bioengineering is pleased to announce that it is nearly finished assembling a team of experts to compile and submit requests to the FDA for Emergency Use Authorizations &/or 510(K) certifications for its fast tests for Covid-19 and influenza. Newgene-US is an American firm that has an agreement with the manufacturer to import the tests, as well as apply for these approvals, in its own name. The expectation is that the specialized team being assembled will be able to drastically reduce the usual FDA approval time.
In addition, the approvals to be sought will be for home-use, & self-testing, without the need for any for prescriptions. Because human factors are taken into consideration for self-tests, and our tests are very easy to perform, it is not anticipated that these sorts of approvals will be overly difficult.
The tests in questions have been shown to be among the fastest, most specific, and most accurate among fast tests…nearly as accurate as the “gold standard” PCR test,,,with a process so simple that self-testing is almost effortless. Unlike the tedious & expensive PCR genetic test, our fast tests require no technicians or medical staff; no laboratory or expensive equipment or, in fact, any reading device at all. Yet, the results, available in 10-15 minutes, are exactly what a concerned citizen needs to know…but would usually require a clinic or doctor to disclose & analyze: For example, our “Lab in a Bag” indicates whether covid or influenza infection is present (& confirms it), or indicates that there was a recovered infection!
All of this comes in a self-contained package, with a cost, including priority postage, for the triple test, that is as much half of the cost of other fast tests. And, to top it off, while other competing manufacturers are “ramping up” their production…our manufacturer can already provide more than 1 millions tests/day, right now!