Let me explain how all this works.
There are multiple types of tests out there but the big issue is getting volume that is needed. Going online and trying to say you can get a test kit is nonsensical as when you try and get it, it either doesn’t exist or you can’t get it.
What makes the predictive situation unique is the as a clia certified lab, they have FDA approval to take it in and they also have volume. I believe they with their partners can supply 1 million per week and grow from there. Let nobody think that this is going to be over in a few weeks. People will be testing for a minimum of 12 months. Here is the FDA law that allows Pred to ship
“ Here’s the quote
D. Commercial Manufacturer Development and Distribution and Laboratory Development and Use of Serology Tests Without an EUA
The policy described in this subsection applies to developers of serology tests that identify antibodies (e.g., IgM, IgG) to SARS-CoV-2 from clinical specimens. This policy is limited to such testing in laboratories or by healthcare workers at the point-of-care. This policy does not apply to at home testing.
Considering that serology tests are less complex than molecular tests and are solely used to identify antibodies to the virus, FDA does not intend to object to the development and distribution by commercial manufacturers or development and use by laboratories of serology tests to identify antibodies to SARS-CoV-2, where the test has been validated, notification is provided to FDA, and information along the lines of the following is included in the test reports”
Next, Pred are not selling to doctors directly. Their sales channel wanted it and were told no. Pred will ship bulk directly to government agencies and/or large hospital groups. The demand is huge and the need is real.
Re the testing and how it works, This is a duel igm/igg test which uses a small drop of blood. Results are in 2mins. It’s easy used and very safe for the user and/or the doctors administrating it. There are multiple others making claims but Pred is the only duel cartridge igm/igg product in the market. Complete game changer.
Also I see somebody questions the timing with serology testing. It’s proven to be more effective and timely than swab testing. The Antibodies appear in the blood in 3-4 days so the test is effective from that time on. For swab testing , you generally don’t go for that until you show symptoms which is around day 3-5. Then you go get the swab (if you can as there are delays) then you wait 4-7 days for results so even at the optimal time with no delays, you get a swab result 7 days after you got infected. With the antibodies test, as soon as you have a symptom you can test. So 3-5 days. The other advantage is you can test again and again quickly.
Stay tuned for more news as I don’t think we have seen the best. Enjoy Kong’s, we have had a tough run but yesterday was a boost
