Member Info for B2HS2L

Apologies if posted before:
https://mobile.twitter.com/mologic/status/1332344793234628609

Sharelover
All you will need for research:
https://filebin.net/yujd97baea20vdou

Agreed - Murky.

But Murky (Clarity of operations, and fiscal reporting) is good of you are building a MidCap position, and probably doing it at the expense of somebody else's market share.
Why reveal all until you have to? - (January)

ShaunP

Re Your Bruker comments, just to remind you of the following:

I posted this on 17.11.2020:

https://www.biotype.de/en.html

Biotype, the German (Dresden) manufacturer and distributor of the COVID-19 CE-IVD test, (RNS 30.03.2020 refers)
is now selling Winterplex.
So that possibly means they are also manufacturing it.

They had clearance to sell COVID-19 CE-IVD direct without supplying NCYT first, maybe the same for Winterplex now.

Ch5 starting now - 'The Good the Bad & the Ugly'
Still has some magic for me

I find altering the 'Posts per page' setting sometimes does the trick, not always though :(

Hi Wilson, - further info on the below 14:04 post
"Wilson63 "ShaunP this looks promising re compass whoever's available please proof read
https://www.fda.gov/media/140078/download".

++++
The above fda link is a summary sourced from the FDA Emergency Use Authorisation (EUA) listing, and is undated.
Listing found here:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#covidinvitrodev

Details of the EUA follow:

Date EUA first Issued: 07/13/2020
Entity: Compass Laboratory Services SARS-COV2 Assay
Product Attributes: Molecular Real-time RT-PCR, Home Collection

The summary contains:

"The assay utilizes the Primerdesign Ltd Novel Coronavirus Strain 2019-nCoV (RUO) (Ref:Z-Path-2019-nCoV)."
It also requires a second Primerdesign product: "Oasig 2X Lyophilized Master Mix, Catalogue Number OASIG-Onestep-150"

"The Compass Laboratory Services SARS-Cov2 Assay will be performed in the
Compass Laboratory Services, LLC’s laboratory located at 1910 Nonconnah Blvd., Suite 108, Memphis TN 38132

I believe from the dates involved, the issue 3 COVID_19_CE_IVD test kit is most likely to be the one used by Compass:

https://www.genesig.com/assets/files/Path_COVID_19_CE_IVD_IFU_Issue_3.pdf
Instructions for Use (IFU) 13 Mar 2020.

Relevant platforms and sampling criteria found on page 2.

Summary:

I was unaware this test kit was being used in USA, and successful PCR requires a 2nd Primerdesign product, a Master Mix.

I believed the only test kit in use in USA was this:
https://www.fda.gov/media/136309/download - Z-COVID-19 (US ONLY)

The Z-Path-COVID-19-CE assay & master mix has been in use in Memphis since 07/13/2020, and has been processing some 'Home Collection' samples.

For Info:
1
Compass Labs website: http://www.compasslabservices.com/covid

2
LinkedIn lists 27 Compass Labs LLC employees (mainly professional people),
13 in Memphis Tennesee, 5 in Alabama, and 9 others.

Haven't found any financial info for company, but to have successfully listed their own EUA,
they must be of some stature.

How can you tell an employee that there sample contains banned substances, when you need their permission to sample for that reason? - The employee would be on the phone to the ambulance chasers pronto.

This article describes a worse mess than at first described.
Tragically will take months to put right.
Good post thanks.

https://trademarks.ipo.gov.uk/ipo-tmcase/page/Results/1/UK00003534431

Application Published - 29 October 2020

Goods and services

Classes and terms

Class 42
Scientific services and research and design relating thereto; diagnostic testing services; laboratory testing services; laboratory services for analytical testing; computer aided testing services; research and testing services in the fields of bacteriology and virology; research and testing services in the field of infectious diseases; development of methods namely establishment and carrying out of physical, chemical, physical-chemical, biochemical, biological, epidemiological, microbiological, molecular biological, immunological and biomolecular testing methods; DNA, RNA and virus analyses for scientific purposes; managing and providing scientific research information, analysis data and results from an online searchable database; consultancy in relation to diagnostic testing services.

Class 44
Medical services; medical services namely blood, saliva, urine, tissue, hair and body fluid testing services; medical testing services in the field of epidemiology and genetics; DNA and RNA analyses for medical and scientific purposes; DNA and RNA screening for scientific and medical purposes; viral screening for scientific and medical purposes; medical and health services in connection with DNA and RNA; provision of medical record services online; collection, sampling and preservation of human blood, saliva, urine, tissue, hair and body fluids; medical testing for diagnostic and epidemiological purposes; medical testing for epidemiological purposes; interpretation of medical biology test results; bio-pathological information and advice relating to medical biology tests; infectious disease testing; medical testing services in relation to the diagnosis and treatment of disease; testing services for humans; provision of advice and information relating to testing services; consultancy in relation to medical testing services.

++++++

This above is specifically what Primerdesign has applied for in terms of class of trademark.

So GM has had since before 17.09.2020 to make arrangements with all involved in the private sector of this testing service.
Planning started > 10 weeks ago, so the planning stage is over and we are witnessing execution.

From your link:
"To receive more information about our multiplex real-time PCR solutions for simultaneously detecting RNA from SARS-CoV-2, Flu A, and Flu B (in development) or for simultaneously detecting RNA from SARS-CoV-2, Flu A/B, and RSV (in development), please complete the form below and a sales representative will contact you as soon as possible."

From 20:36 post -
"Once approved: Testing described on this webpage will be designed and intended (i) for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures (ii) for use under the Food and Drug Administration’s Emergency Use Authorization."

So I would say
1 still in development and not approved under FDA EUA yet.
2 Only US labs certified to perform high-complexity tests will be able to use this assay.

Much discussion on this subject on 21/22 Nov Ravenox, too much to precis.

Hi Wilson,

https://www.thermofisher.com/uk/en/home/global/forms/clinical/taqpath-covid-19-flu.html

Take a look at the footer of this web page:

"The real-time PCR kit for SARS-CoV-2, Flu A, Flu B and the real-time PCR kit for SARS-CoV-2, Flu A/B, and RSV described on this webpage have not been CE marked, or authorized by the US FDA or global health agencies, Consult the User’s Manual for information on authorized indication, warnings, and precautions. Once approved: Testing described on this webpage will be designed and intended (i) for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures (ii) for use under the Food and Drug Administration’s Emergency Use Authorization. Testing is limited to laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform high-complexity tests."

Important
"(ii) for use under the Food and Drug Administration’s Emergency Use Authorization. Testing is limited to laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform high-complexity tests." - so USA lab usage limited.

Just a guess Wilson:
1 Right click web page
2 select 'view page source'
3 press shift F3 and place 2020 in the search field presented
4 Observe where 2020 appears in the page
5 The page would appear to have been generated on 11/24/2020, as its the only date found.

Just getting this out there..

IF - and this is a big IF - Novacyt can afford to purchase a US company on NASDAQ,
(we are advised to expect further M&A activity),
the default situation I believe will be that NCYT will be resident on 3 exchanges.
If this is correct, - will it be beneficial to reduce representation to just two exchanges, and which one would be best to drop?

Sorry completely ignorant on this, but I don't want to be unprepared.

From poster uk2day on ADV*N:

24.11.2020 - Institute of Biomedical Science (IBMS) statement on Sars-CoV-2 Rapid Testing Options

Has some interesting information on LAMP testing, and has links to further information:

https://www.ibms.org/resources/documents/ibms-statement-on-sars-cov-2-rapid-testing-options/

Thanks Ad4you for your response.
At the end of the day it does not matter which turns out to be the right pov, so long as we don't lose money opening yet another income stream.
GM has my vote, vaccine or no vaccine.

At this price, I bet GM is getting ready for another top-up as we speak.

The question you have to ask yourself is do you believe this company has the ability to become a MIDCAP?
Absolutely, and only 70 Million shares in issue. YeHa!

https://www.btnews.co.uk/article/16906

Article: BA and American Airlines launch tests
Tests provided by LetsGetChecked.
Perhaps one for the spreadsheet ShaunP?