Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
FIND updated it’s list too , added/updated Genedrive yesterday.
https://www.finddx.org/product/genedrive-96-sars-cov-2-kit/
Very informative if anybody is interested.
https://www.fda.gov/media/147952/download
There must be some announcement soon , all BC genomics staff promoting GDR kit since yesterday.
https://www.linkedin.com/posts/activity-6792774320402833408-hXB5
BC promotion :
https://www.linkedin.com/posts/owen-mccann-2526a241_quicker-streamlined-covid-testing-activity-6792438585195827200-dm0t
I wish we get an update on POC coming week..
https://www.gov.uk/government/publications/how-tests-and-testing-kits-for-coronavirus-covid-19-work/target-product-profile-point-of-care-sars-cov-2-detection-tests
Maestro , Do you know the market dynamics ..:-) , it’s fallen from high 700’s to 360 , it’s only 15% and you are on the moon .. finish your champagne and come back , reality is waiting for you.. meanwhile did you take your pills today ?
I think most of the guyz here for COVID front but not many people know what actually GDR does other than covid :-) , it is disappointing as there is no sales yet but future is very optimistic, HEP C and AIHL are very big for GDR, anyone in pharma business know about this, GDR’s decentralised HCV Id kit is unique that’s why I am expecting good sales. Coming to covid side, it’s not far from over the virus is regularly mutating, very soon all the cheap tests will disappear from the market , We will get recognition soon.
Only thing worries me here is timing of RNS, every time when there is a RNS we see large trades being reported last 2 or 3 days , we get a good rise after the RNS and they all sell on the same day or very next day , small PI’s money at stake . I might be totally wrong but there is a good chance of insider trading.
The EUA approval is in full swing now , I feel W e are not too far from EUA .
https://www.fda.gov/media/147800/download
https://www.fda.gov/media/147795/download
How I am able to find these documents is funny , I am not sure if it is a data breach or a glitch , keep adding one number just before /download word in above url . You may find lot of internal documents ..:-)
147795
147796
147797
I think the update we may get is from Indian side .
https://www.linkedin.com/posts/kanav-kahol-715450112_health-covid-activity-6790973777606967296-PnvJ
This is very interesting to read , especially towards the end.
“ Okay. So, you know, to clarify the high throughput is really because, you know, that will help increase the testing capacity which is, you know, what is needed at this stage for, you know, as we try to get more routine testing done...
Right.
...through routine testing programs. Kris Do you want to talk about the validation that we would look for there?
Sure. Yes I think, you know, if the test is going to be distributed with a high throughput workflow, you know, that’s the workflow that should be validated. You know I think performance in a 96 wheel just for instance performance in a 96-wheel plate may be different than a 3-to 4-wheel plate right? Heat transfer is different. Optimal characteristics perhaps are different. So I guess what we don’t want to see is, you know, like a manual workflow done in the, you know, validation. And then, you know, kind of maybe just an LOD study or something, like, that to validate the high throughput.
I think what we want to see is that the high throughput solution is kind of producing, you know, acceptable results because, you know, that’s really the solution that’s going to impact, you know, testing the most.”
Link:
https://www.fda.gov/media/147771/download
A good read while you waiting for EUA:
On April 20, 2021, pursuant to Section 564 of the Act, in response to public health needs to expand the nation’s testing capacity,2 FDA is issuing this letter to authorize additional indications for EUAs that are within the Scope of this Amendment (Section II). For such indications, use is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meet requirements to perform high complexity tests, except that tests authorized for use in specific named or designated high complexity laboratories can only be used in such laboratories.
https://www.fda.gov/media/147737/download