Member Info for ak_gabba

Hillseeker and DRB83,

I think you are correct. The promate on the exempted list could well be 2 tests.

https://www.primerdesign.co.uk/assets/files/path_promate_covid_19_ce_sted_ifu_issue_600.pdf

They are listed in the IFU issue 6 as being 2 catalogue numbers
genesig® q16 (Catalogue: D00050)
genesig® q32 (Catalogue: D00051)

That would make the exempted promate as being 2 tests and the recently approved test being 1 leaving 8 to be approved.

Interestingly though I notice that on the link

https://www.gov.uk/government/publications/covid-19-test-validation-approved-products/medical-devices-regulations-2002-protocol

Promate is listed as IFU issue 10.00 (23rd July 2021). I'm only able to find issue 6 (25th March 2021). Can anyone find issue 10 or previous? It looks like the IFUs have gone through quite a few updates. Looks like they are listening to their customer base :)

Hillseeker,
Ah! I see what you mean. It does mention 8 waiting on approval however I only see 1 approved and 1 exempted. I read the same promate test but for 2 devices. It also refers to each test in the singular.

Hillseeker,
The RNS states
"Novacyt's genesig® COVID-19 assay was launched on 31 January 2020 and was one of the world's first commercially available tests for COVID-19. To date, the genesig®COVID-19 test, which targets the ORF1ab gene, continues to be able to detect all known variants and mutations of COVID 19, with over 4.5 million sequences analysed, as documented in Novacyt's latest weekly bioinformatic surveillance report."
It's the original 1 gene test that has been approved. By my maths we have 1 approved and 1 exempted from 11 submitted. Want to see which ones are pending and hopefully not pending for long!

RBMInvest,

Our test can pick up on all the strains as per the sequencing reports that get released however it's a binary positive or negative result. It's excellent that they have confirmed that it will pick up on this so can still be reliable used as a PCR test to pick up on all known variants. We do offer the SNPsig tests and escapeplex which can be used as assays

The TaqPath which is used at the labs have the software which can determine which genes returned positive or dropped out.
The approved test and promate is primarily focused towards pillar 1 testing sometimes referred to as point of care although there are a number of private suppliers and labs which also use those tests for fit to fly and test to release PCR tests. Our tests were also being used with AZN in their labs at the start and was confirmed in Feb this year that covid-HT direct was being used at one of the lighthouse labs.

https://novacyt.com/wp-content/uploads/2021/02/Novacyt-RD-Update-24.02.2021-ENGLISH.pdf

I'm assuming that covid-HT direct is one of the tests waiting on being approved. I'd really like to see which of our tests are waiting on approval in particular this one as i'd like to see us being used more in pillar 2

https://www.genesig.com/assets/files/path_covid_19_ht_3g_ce_sted_ifu_issue_1_00.pdf

RBMInvest,

My understanding is the TagPath test is used at the "super labs" and the result is given as positive or negative with the positive result also providing information as to which genes detected the positive result. The S gene drop-out has been getting used as a way to identify the possibility of different strain.
Sequencing can then be used to confirm the exact or new strain or a specific assay can be used if one already exists.

DRB83,

The TaqPath test is on the list. was on the original list along with Roche

https://www.gov.uk/government/publications/covid-19-test-validation-approved-products
Click on the download for COVID-19 test validation approved products
TaqPath(TM) COVID-19 CE-IVD RT-PCR Kit

https://www.thermofisher.com/uk/en/home/clinical/clinical-genomics/pathogen-detection-solutions/covid-19-sars-cov-2/multiplex.html

Our 1 gene test is on the list and promate is on the exempted list

https://www.gov.uk/government/publications/covid-19-test-validation-approved-products/medical-devices-regulations-2002-protocol

scottyboyblue, Cyber Monday follows black Friday and is usually the busiest day for online orders.

"the country in which the manufacturer is established" we are the only UK one on that list.

excellent find growhydrodude1 larry and kaeren

it looks like Dr Ruth Powell moved on prior to covid and was involved in novaprep

https://www.linkedin.com/in/ruth-powell-08489316/?originalSubdomain=uk

flushfrank, do you have a link for that please?

I'm assuming amazon won't be using visa to pay ;-)

Pillar 2 capacity has dropped not sure why. Pillar 1 capacity remains steady. Hopefully they will require more promate and keeping an eye on ctda for updates on their desktop reviews

https://find-and-update.company-information.service.gov.uk/company/12031776

I think the company runs through the above entity

Poidster,

PROmate COVID-19 is on the list and is OK until 28 February 2022. The labs can continue to use this product. The list of those tests are

https://www.gov.uk/government/publications/covid-19-test-validation-approved-products/medical-devices-regulations-2002-protocol

Hopefully it will move onto the approved products shortly. Unable to find any other info on the other products which we are waiting on being approved.

The docs haven't been updated since 3rd Nov and the whole process has received much criticism.

GM bought shares not long after the vaccine news sent the share price down. he would also have been aware of the payments coming in from DHSC which at that point was not in dispute. He may well have thought phase 2 was a certainty.
I'm sure he isn't concerned about money though and the loss he has made in that share purchase probably won't bother him. i'd like to think he's holding for the long term

private eye are in essence asking for full transparency from the government and the companies involved over PPE and test and trace so that the public can see where all the money went.

it is unfair for novacyt as the accounts are there to see along with the DHSC payments. private eye have been able to stich a lot of info together and come up with that table however there are many more companies which they couldn't add to the table as they didn't have the information.

HarChris,
There is a table with primerdesign at the top of profit margin for Covid first period (15 months). That doesn't look good in print.

There is however an interesting section titled "leaky bucket"

"Baroness Harding told MPs this July included a large bucket of £2.2bn in the form of commercial savings where we were able either to negotiate lower rates or to stop doing non value added work with various partners"

I think we fall into that category.

https://twitter.com/ak_gabba/status/1458528195700043776

might not be up for long. it's 8 pages in the private eye with a short write up on primerdesign

not sure if this has already been posted however I spotted an anounement from ABHI re the CTDA process

https://www.abhi.org.uk/resource-hub/file/13042

Here are some of the results for oxford immunotec
http://www.oxfordimmunotec.com/north-america/news/oxford-immunotec-reports-fourth-quarter-full-year-2019-financial-results/
http://www.oxfordimmunotec.com/north-america/news/oxford-immunotec-reports-first-quarter-2020-financial-results/
http://www.oxfordimmunotec.com/international/news/oxford-immunotec-reports-second-quarter-2020-financial-results/
http://www.oxfordimmunotec.com/international/news/oxford-immunotec-reports-third-quarter-2020-financial-results/

looks like they were keen on their TB diagnostics

https://www.medtechdive.com/news/perkinelmer-buys-oxford-immunotec-591m/593038/

Its all speculation but the appointment of Janet Kidd does look interesting. I'm sure she is well thought of by David due to working together in the past but her recent association most likely during the legalities of a takeover does raise the eyebrows.

belter! if only my attitude could magic up revenue forecasts. I'll try harder :D

without knowing what revenue forecast for Q1 2022 or H1/2022 it won't be anywhere near £8