Novacyt Gets Big Order For Covid-19 Test From Public Health England
from Alliance News | 16th March 2020 12:25
(Alliance News) - Novacyt SA on Monday said Public Health England has placed an initial order worth GBP1.0 million for the Covid-19 test manufactured by its Primerdesign unit.
Shares in the clinical diagnostic company were 14% higher in London on Monday at 128.65 pence each.
Last week, Novacyt said it was working with the US Food & Drug Administration to secure emergency use approval for the Covid-19 testing product. It had added that Public Health England was "very satisfied with the performance" of the product.
Novacyt launched a CE-Mark approved molecular test for the clinical detection of the novel coronavirus COVID-19 in mid-February.
The clinical diagnostic company said the COVID-19 test is the first CE-Mark test for the 2019 strain of novel coronavirus and follows the company's rapid launch of its research-use-only coronavirus test on January 31.
"Orders are initially for eight hospitals to provide stocks in those locations for four weeks of planned testing," the company said Monday. Which makes it the largest single order received to date for the test.
As Friday last week, Primerdesign has sold and received orders for over GBP3.7 million of the CE-Mark Covid-19 test, it had said. This would normally represent about 8 months of sales for the company.
Chief Executive Graham Mullis said: "We welcome Public Health England's decision to use our Covid-19 test in the UK, and I am delighted to see that Novacyt will now be supporting one of its home markets during these challenging times. The number of countries Novacyt is now supplying with its Covid-19 test has reached over 60 and we expect this will continue to increase.
"The team at Novacyt and its key suppliers are working extremely hard to support clinicians around the world in the fight against this pandemic and, as a chief executive officer, I am immensely proud of everyone's commitment."
By Paul McGowan; paulmcgowan@alliancenews.com
Copyright 2020 Alliance News Limited. All Rights Reserved.
This news will reach Orangemen and considering how anti world he is will this affect Novacyt. Will they look at NCYT as a UK company? US is a large market in addition to the world and the difference is testing will be the widest in US compared to rest of world with facilities of private labs unlike rest of world. FDA EAU therefore has significant bearing on SP near term.
France Hits Apple With EUR1.1 Billion Fine Over Treatment Of Retailers
https://www.ii.co.uk/news/france-hits-apple-with-eur11-billion-fine-over-treatment-of-retailers-al1584355007039726700
Every NHS trust has 3 to 4 hospitals under its care outside of Big cities. Thereafter there will be one BIG LAB that services 2 or 3 neighbouring trusts. So one cannot use each hospital in calculations. PCR machines are located in the big lab only not in hospitals.
So please dont use simple maths. Does not work that way. By the by am Long
https://www.channel4.com/news/exclusive-why-frontline-health-workers-may-not-be-tested-for-coronavirus-even-if-they-have-symptoms
Surely this decision was considered seriously. How daft this govt can be and how can they let down front line staff.....selling them short secretly. More people will get infected in hospitals if health care staff are not tested during or before returning to work
https://mobile.twitter.com/Channel4News/status/1239279861757345795
Published 15 March 2020
Some manufacturers are selling products for the diagnosis of COVID-19 infection in community settings, such as pharmacies.
The current view by PHE is that use of these products is not advised:
some of these products look for virus while others look for the bodyâs immune response to the virus. Such tests are very rapid and can work on a range of specimens including serum, plasma or finger-prick whole bloodthere is little information on the accuracy of the tests, or on how a patientâs antibody response develops or changes during COVID-19 infection. It is not known whether either a positive or negative result is reliablecurrently there is no published evidence about the suitability of these tests for diagnosing COVID-19 infection in a community setting
https://www.gov.uk/government/publications/covid-19-rapid-tests-for-use-in-community-pharmacies-or-at-home/covid-19-rapid-tests-for-use-in-community-pharmacies-or-at-home
Very Good article and worth reading and looking at all simulations shown in article. Shows how testing becomes important in such a scenario
https://www.washingtonpost.com/graphics/2020/world/corona-simulator/
Read the links to the approval given. Same wording for approval given.....stating no alternative for the test submitted for all 4.
Primer will get its FDA soon as they want additional tests for hospitals and other private sector.
All speculation of tie up with Roche is incorrect.
Problem with NYCT primer is they have the kits but not the labs facilities backing for use of the test kits like the big 4 approved. So fall back in the line. Moreover US seems to be happy with a turn around of 24 hours for now so 2 hours or 3.5 hours of Roche or longer of cobs perhaps does not make a difference. CDC and FDA are happy their ars* s were saved with the big boys ramping tests for now.
In Vitro Diagnostic ProductDate of EUA IssuanceLetter of AuthorizationFederal Register Notice for EUAFact Sheets and Manufacturer Instructions/Package InsertEUA
1.CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel (CDC)
February 4, 2020
Letter of Authorization (PDF,  286 KB)
 2.New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel (Wadsworth Center, NYSDOH)
February 29, 2020 (initial issuance)
March 10, 2020 (reissuance)
Letter of Authorization  (PDF, 312 KB)
3. cobas SARS-CoV-2March 12, 2020
Letter of Authorization (PDF, 111 KB) (February 4, 2020) TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific
4. TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.)March 13, 2020Letter of Authorization(PDF, 105 KB)
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#2019-ncov
Supposedly this test removes need for the nose or throat swab to be manually transferred to the amplification tube of the testing kit. This makes it automated as the tubes are directly loaded to the PCR machines and therefore is faster for thousands of samples to be processed faster
Need to check if Primer design kit can be used for automated testing. This is what Dr.Deborah stated in press conference a minute ago.
She clarified that this is RNA amplification test automated with turn around from time of collection to be 24 hours for result.
She categorically stated POINT OF CARE TEST is 6 MONTHS away
Looks like they want shares as they are offering at higher than current SP. With Paris price equivalent at 115p currently.
Why would they do that when they always offered 4 to 5p below the current SP all these days.
Last 5 minutes they are offering same price without any change for even 20K order :)
You all ever seen or wondered why doctors and nurses in protective gear pull out 12 hour shifts without peeing or eating much to treat covid patients? If all call it equivalent to flu why the hell dont you see similar protective grabs while treating flu ????
Covid-19 is killing front line medical staff in many countries sadly. No one highlighting it. Hmmm now we need to wonder if ye guys will work on a ward full of sick covid patients ( saying it is only the bl**dy flu) and come back home daily, worried you might pass it on to the family including any parents at home.
If infection spreads rapidly nations health systems will be overwhelmed and with limited respiratory and specialised beds needed to treat death rate will be higher than " just like the flu". Sadly people with much needed surgery for cancer will get bumped and if you have no cancer problem needing urgent attention you better see you local voodoo doctor.
Countries dont fe*kin shut down at great economic cost if their health advisors thought it was a goddamn flu. People believing China infection is under control is dreaming with still half a billion under lockdown and all mass transits closed.
Ken nice to note you have a great relaxation
Here is view of the expert of a infection control director Dr.Fauci
https://www.google.com/amp/s/reason.com/2020/03/11/covid-19-mortality-rate-ten-times-worse-than-seasonal-flu-says-dr-anthony-fauci/%3ffbclid=IwAR0D7URoNJcG_oU5ruMoPKE4fCLwoODMt1Luguog5nGdOtAu6Bz_-1RWKWw&
We are now in the phase of the response where demand for testing is greater than the tests available, even when the private/commercial sector is doing testing," Blank said in an email.
You wonder what they are doing in USA. Anyway reading this article it looks like sales will be very good in USA. Qiagen can't keep up productions. Interesting read
https://www.google.co.uk/amp/s/amp.usatoday.com/amp/5013586002
0n 9th March India started and now Thailand follows. This may be adopted worldwide as just thermal scanning is not good enough. US may also adopt this for their internal flights. :)
https://www.channelnewsasia.com/news/asia/thailand-travellers-medical-certificate-covid19-coronavirus-12523520
More info
Azar stating CDC sending kits go to public lab and they only report.
900000 tests have gone to hospitals, private labs and the tests they do are not being reported back to CDC currently and they are setting up networks to report back.
As per Alex Azar at White House coronavitrud task force briefing ongoing now. 4 million tests will be dispatched in next 2 days. So 2 private companies DYOR.
Labcore and quest will be using the kits for diagnosis using their lab analysers therefore.
I will certainly wait to buy Kaz in the long run about a month down the line as it has good value...not Glen. Have profits on standby trading regularly in the other stock.
As I said previously waiting patiently is a b****h. People jump in too early. There will be enough froth to ride on the way up when market decides it has bottomed and rises. Bankruptcy for many leveraged companies sadly around the corner.
No matter what people feel about current covid-19 there is nothing one can do as world is infected. Chinese economy is in downward spiral for now. Second wave of infection will start in china once they allow the half billion free who are locked down now. Without vaccine sadly more will die than Flu in a year as this will linger into next year.
About 3 weeks ago said "cash is king before market crash started". Nope not hindsight.
FIND is working closely with WHO to provide support on training, technical assistance and capacity building to ensure access to accurate and high-quality diagnostic testing for SARS-CoV-2. Together with a third-party, referral laboratory, FIND is conducting an independent evaluation of multiple SARS-CoV-2 assays that are currently in use and will become available in the future. The primary objective of these studies is to independently verify manufacturerâs claims on the analytical lower limit of detection (LOD). The FIND study will also establish diagnostic accuracy using positive and negative clinical specimens from several affected areas. Results from these studies will be shared with the global health community so that countries have objective and independent evidence on the performance of available/eligible SARS-CoV-2Â in vitrodiagnostics.
Both molecular tests and immunoassays will be considered and there will likely be multiple rounds of evaluation: tests that detect nucleic acid will be prioritized first, and immunoassays (manual, automated or lateral flow) will be assessed at a later date.
Due to the high number of submissions received, we are keeping this EOI open until 11:59pm CET, 9 March 2020.
ttps://www.finddx.org/covid-19/
(Will become norm as governments around world copy the action from a long term point of view as air travel cannot stop once it is pandemic)
Air Travellers from Italy, S Korea to carry medical certificate
Mumbai: Air travellers having visited or arriving from Italy and South Korea will require to submit a certificate of having âtestedâ negative from a health authoritiesdesignated lab in their countries for coronavirus at the departure airport, a senior DGCA official said on Thursday. The fresh travel curbs, which are in addition to the visa restrictions already in place, would come into effect from midnight of March 9 and will remain in place until cases of coronavirus subside, he said. The new measures come amid 29 people, including 16 Italian tourists, tested positive for coronavirus till Wednesday. The list includes the first three cases in the country from Kerala last month. Three persons have been discharged following recovery. âIt has been decided that in addition to visa restrictions already in place, passengers travelling from/ having visited Italy or South Korea and desirous of entering India will need a certificate of having tested negative for Covid-19 from the designated laboratories authorised by the health authorities of these countries,â the official said. This is a temporary measure till cases of COVID-19 subside and will be enforced from past midnight on March 9, the official said