The latest Investing Matters Podcast with Jean Roche, Co-Manager of Schroder UK Mid Cap Investment Trust has just been released. Listen here.
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Tired of delays, U.S. labs ask FDA to develop their own coronavirus tests
Monday, February 24, 2020 3:28 p.m. CST by Thomson Reuters
By Julie Steenhuysen
CHICAGO (Reuters) - U.S. state and local public health laboratories are seeking permission from the Food and Drug Administration to create their own tests for the new coronavirus as manufacturing and regulatory issues continue to delay access to testing capabilities.
As of Monday, only five U.S. states - California, Illinois, Nebraska, Nevada and Tennessee - have the capability to test for the virus, according to the Association of Public Health Laboratories (APHL).
The group, which represents state and local public health labs, sent a letter to FDA Commissioner Dr. Stephen Hahn seeking permission to develop tests for the virus.
The request follows continued delays in getting access to a test developed by the U.S. Centers for Disease Control and Prevention, which was granted an Emergency Use Authorization by the FDA earlier this month. The FDA grants such approvals in the event of public health emergencies to speed access to needed tests or drugs.
The CDC said in a news briefing last week that the agency is still handling the bulk of testing for the coronavirus as it works out issues with test kits sent to states.
After receiving the tests, some labs discovered they produced inconclusive results, and they have been waiting for replacement tests as the CDC has been trying to work out those issues, said Scott Becker, APHL chief executive officer.
The CDC and FDA did not immediately respond to emails seeking comment.
Becker said it is not clear when the new test kits will arrive.
"We're weeks and weeks into this response and the desire is to begin community-based surveillance and make sure we have the diagnostics as close to the population as possible, and we're not there," he said.
The World Health Organization has cited expanded diagnostic capacity as a critical component to containing the fast-spreading virus, which has spread to some 29 countries and territories outside of China, killing about two dozen, according to a Reuters tally.
(Reporting by Julie Steenhuysen in Chicago, Additional reporting by Trisha Roy in Bengaluru; Editing by Shounak Dasgupta and Dan Grebler)
The USA screwed over the british aircraft industry in the 1960s they screwed over BP , when an american contractor failed at deepwater horizon , why under Trump would they favour a french company?
Asked by conservative commentator Geraldo Rivera if China was telling the truth about coronavirus, Mr Trump said: “Well you never know. I think they want to put the best face on it, so you know I mean if somebody, if you were running it you’d probably, you wouldn’t want to run out to the world and go crazy and start saying whatever it is because you don’t want to create a panic.”
Because Trump has told them to base decisions on "America First", - it don't matter if the decision takes alittle longer..
posted last night but relevant here:
https://www.rapidmicrobiology.com/news/primerdesign-the-first-european-team-to-deliver-to-the-world-a-2019-ncov-diagnostic-kit
See the last question:
Q: What will happen should the virus continue to mutate?
A: Viruses inherently have a high mutation rate. Should the targeted region of the virus mutate, the specificity of the assay may be reduced, which would be the same for any competitor kit or PCR assay. To combat this, as the sequence data is collected from newly 2019-nCoV infected patients from around the world and then published, our in-house bioinformatics team reviews this daily to check our detection assay has homology with all of these published sequences, and can still detect all positive 2019-nCoV samples.
Thus, the in-house bioinformatics team reviews newly published swab data, to ensure the detection assay can still detect all positive 2019-nCoV samples.
So as long as the bioinformatics team are kept busy with fresh data, medical authorities can be assured that Primerdesign knows how the virus is mutating (or not), and will instigate any measures required that assure the detection assay is still fit for purpose.
How many competitors can make this claim?
This might be the reason why the CE mark has been awarded.
Few jobs going there
https://novacyt.com/careers/
AngryAnt, the CDC developed their Coronavirus test on a Qiagen PCR and started testing on 1/21. On 1/25 they ordered more Qiagen, stating it was the only machine they could use. By 2/4 they were telling labs to use the CDC test kit with a Applied Biosystems 7500, which obviously failed.
CDC have since purchase more Qiagen equipment which has been installed and calibrated about two weeks ago and its likely they are validating the equipment hence the delay. Although they could be testing and we don't know it.
Mornington - looks like they need to take more staff on in investor relations
AngryAnt, to me it sounds like they've been delaying to save face. The Trump administration has been desperately trying to shut down the CDC for a while and word has it they're not wanting to admit there is a problem.
Hi Im new to the group. Only a small time investor, in it for the long haul and in healthcare so quietly stalking the threads googling the jargon.
Looking at the Current situation I would hope the FDA would approve all companies applying for product approval as its now a global emergency. I m also surprised its not been done sooner esp as the Novacyt test is quick and appears user friendly.
I think the way its going the demand for any test could out strip supply if they re not careful.
I would also think they have to be very careful what they report /update as the situation is changing rapidly and Id imagine they d be in talks daily with health officials but maybe not disclosing everything.
Does the virus know we are waiting for authorisation?