Member Info for B2HS2L

19.12.2020 - Dept of Health Republic of South Africa.

https://www.nicd.ac.za/wp-content/uploads/2021/01/New-Variant-of-SARS-CoV-2_Frequently-Asked-Questions_v10_18-January-2021.pdf

* Matric Rage = 1,300 teenagers from Gauteng are being sought for Covid tracing after they attended the 2020 Ballito matric rage event.

It would be a refreshing change if our Public Health Authorities spelled out the problem as they saw it like this FAQ list.

Yeh, me too, - I 'm sure their working on it.
I would be if sales depended on what looks like a crossword matrix!

Look what's there!...

Just about everything in the Primerdesign catalogue...

I advised GM of the possible problem, lets see what happens.

https://www.luminultra.com/tech/genecount-qpcr/
Naughty Canadians.

Shaun,
Allan 6050 tonight:
"Amazing how low the daily trade was today only 837 on Friday it was nearly 1800"
I think if it were even a whisper that something was happening at 7am tomorrow morning, we would have had quite a lot more trades today, but sp seems set fair for further progress this week.

Shaun,
There is a fair chance that Thermo-Fisher were looking at what Mesa-Biotech R&D were working on,
and may have liked what they saw.
But one test every 30 minutes in these chaotic times is poor, I mean there are many environments where this instrument is pretty much useless.

Conversely - When we purchased IT-IS, it is highly likely IMO that this mature company had R&D projects that were being advanced.

From 15.10.2021 RNS
"In addition, an earn out of up to £1.9 million in cash is payable to the directors of IT-IS over the next two years, subject to certain manufacturing targets being achieved".

In truth, this statement might have included reference to development of R&D projects (in particular modification of MyGoPro as an Isothermal instrument instead of a thermo-cycler for use with the new LAMP assay VARIplex).
ie Modification to adapt the instrument for use with the VARIplex product?

After all 2 years is a long time to hit any (far sighted) production target, or am I speaking out of turn?

Yes Indeed Shaun, - The product most like this one seems to be DNA Nudge, and we don't hear too much about its use in any environment, but we should not be complacent I suppose.

Here is the product that Thermofisher have purchased (mesabiotech):
https://www.mesabiotech.com/
https://www.fda.gov/media/136355/download (IFU)

Also:
https://www.fiercebiotech.com/medtech/thermo-fisher-nets-handheld-covid-19-test-maker-mesa-biotech-550m-deal

....President and CEO Marc Casper said that 2021 would see Thermo Fisher quickly accelerate its long-term roadmap of M&A plans, as he outlined during last week’s J.P. Morgan Healthcare Conference.

Casper also expects to post 25% growth for the full year of 2020, including “well over $6 billion in COVID-19 response revenue,” he said. Last October, the company reported $2 billion in coronavirus-related sales alone for the year’s third quarter, out of $8.52 billion total. Thermo Fisher’s next earnings report is scheduled for February 1.

Meanwhile, the San Diego-based Mesa Biotech—with its rapid, molecular Accula tests available at the point-of-care for COVID-19, as well as the flu and other respiratory diseases—brings about 500 employees and about $45 million in 2020 revenue.

++++

1 test every 30 minutes.

I know which company T-F would have liked to have purchased, and its not Mesa.

HarChris, - Thus demonstrating the Darwinian evolutionary theory - Survival of the fittest.

Hi Kaeren

The FDA EUA listing containing the genesig® Real-Time PCR assay can be viewed here:

https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas

(Use the Search facility by entering Primerdesign in this field)

Last part of the listing is 'IFU', - click on that and the IFU document appears at issue 1.03

This is authorisation for Primerdesign to sell issue 1.03 of the assay in US.

On Page 2 of the IFU you see 'Z-COVID-19 (US ONLY)' at the bottom of the page.

Other part numbers of the assay exist (Z-Covid-19), but only this part number (US ONLY) has FDA EUA clearance.

+++++++++++++++

Also in this entry you can see a column 'Authorised setting(s)'; the setting assigned by the FDA is 'H'.

This explanation is visible at the foot of the listing:

'Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests'

+++

So only the 3 platforms mentioned on page 2 can be used to process the assay, and only when used in a lab cleared to perform high complexity tests.

q16/q32/Mygo are not listed, and I have highlited this because because some investors might be unaware of these requirements.

If you view other EUA's most will say the type of lab that can process the assay, and the instrument(s) to process it with.

I think this is why you cannot go to a US airport, get a PCR test, and expect results to be ready soon.
All samples have to be processed off airport in a lab.

This is my interpretation of the IFU, so sing out if you have a different Point of View.

If the trend has continued, it's possible it has become nearer 50 / 50

ChasPB

Taken from NCYT AGM 30 Sept 2020 (video)

Beginning of 2020 Euronext: 95% of shareholding traded on Euronext, 5% on UK AIM

September 2020: 70% of shareholding traded on Euronext, 30% on UK AIM

++++

"French address/Paris location is always mentioned first in company communications"

I always assumed that was because Novacyt bought Primerdesign. ;)

Hartlebury @ 11:49
"I just wonder why you think they should attract more institutional investors right now?"

With more II investment, there is less of the 70 Million shares available to purchasers should good news force the sp higher.
IMO this will cause large sp swings, because MM's will 'tree shake', and drop sp to new lows.

There isn't likely to be an increase in shares soon, unless GM has plans for a really big purchase.

Feel free to kick this around it's just my opinion, but this happened a lot last Feb / March with I believe 68 Million shares in issue.

The image of GM reminds me of a tuning fork.
GM tuning in to the needs of NHS and the global market.
If his projects are on track, we are due a re-rate or two (depending on news flow), but beware large sp swings with so few shares available.
Good Luck timing your exit if that is your aim.

From Half Year 2020 Results RNS 17.09.2020

Strategy update highlights

• Selective product/technology and company acquisitions to generate additional revenues and profits to offset potential future reductions in COVID-19 revenues and enhance the Group's trajectory towards becoming a market leader in respiratory and transplant clinical diagnostics

• Acquisition of specific assets to enable Novacyt to expand its core capabilities whilst maintaining attractive margins - (meaning IT-IS)

NEXT STAGE OF GROWTH

Novacyt has demonstrated during the last six months the financial value and profitability it can generate in the right clinical IVD markets with a low-cost base. To achieve additional revenue, the Company will continue to invest in R&D to drive new product development. Novacyt also plans to accelerate revenues and additional profitability through selective and accretive acquisitions. These actions are expected to replace any potential lost revenues from a future decline in COVID-19 testing.

+++

*Selective product/technology and company acquisitions*

Note the word PRODUCT, I think the next purchase may be a product.
We are trademarking VariPLEX & VARIPLEX (https://trademarks.ipo.gov.uk/ipo-tmcase/page/Results/1/UK00003577539),
and we would not be doing that because the owner of 'variplex' would definitely object.

So my question would be what has NCYT to gain by purchasing the whole of Amplex Diagnostics, as opposed to one of their products?

From Amplex website - https://www.eazyplex.com/about-us/

Our products:

With the eazyplex® system Amplex provides the newest sophisticated technology in an easy and userfiendly way. The system is based on isothermal amplifikation (LAMP) and Real-Time-Detection in an intuitive device. The lyophilised and ready to use reagents result in user friendlyness, speed and reliability, which are constituents of our concept. These advantages of our system are appreciated by all our customers, from small hospitals, big university institutes, laboratory consultants to ambulatory health care centers.

Our hyplex StaphyloResist® was the first CE IVD marked MRSA multiplex-PCR test in the world evaluated for direct testing from sample material. On the same platform the first ESBL test was established. And so it is just a chain of reasoning that Amplex is just now one of the first suppliers for CE IVD marked diagnostics based on isothermal amplification, again at the forefront.

Note: the product fyler of the variplexTM kit is available at the bottom of the eazyplex.com website

Feel free to place a hole below the waterline here.

If NCYT are interested in the company, there would not be much diversification with this purchase.

Hillseeker, I feel the LTH's have done a lot of the hard yards, - it's easier to stay invested now than it was.

This is what Lee Lomas - Head of Corporate Partnerships at Excalibur Healthcare Services Ltd has to say about Excalibur on LinkedIn:

"Excalibur Healthcare Services is experienced in the field of medical supplies and logistics internationally having served clients in the MENA and South East Asian regions successfully for many years."
++++
Question:
If there has been a 'partnership' with Excalibur, does it explain why Primerdesign did not appear to have suffered from lack of supply of hard to obtain materials to manufacture Assay's in the early part of the pandemic?

More digging required.

The next bullet point says:
"Sir Chris and the Excalibur testing team have developed a highly reliable and accurate Cov2 rapid Antigen test that outperforms all other matketed Antigen tests.
Excalibur has also developed a new and rapid lab-based PCR test for Covid."

+++

Competition warming up, doesn't say when the competition is set to arrive.

Good Spot Bing.

Apologies Airlineboy if you've seen this, but I don't think you did.

Airlineboy, your 04.01.2020 15:17 post
'What worries me a tiny bit is that we might be inadvertently building ourselves up for disappointing news come the end of January (I really hope not). Time and again on Twatter, Primer Design have made it known that they have unlimited tests available to anyone who might wish to purchase them with their full contact details. I confess I worry about that, surely we should be flat out with little or no surplus tests available?'

My response:
Tonight I reacquainted myself with some of the content of this video:

30.09.2020 AGM video 25:00 mins - Anthony Dyer:

"We have chosen to invest heavily in building a strategic level of inventory because that allows us to respond rapidly to any demand anywhere in the world, so a selling point of ours is not only can we make significant amounts of this stock but we are also able to deliver quickly wherever need is identified.

...Capital expenditure in this business, as with many in diagnostics is not a strong feature of the business.
This year we have not spent, nor have we needed to spend significantly on capital expenditure, and part of that is explained by the fact that some of our expansion is through use of subcontractors, and where we have expanded our internal manufacturing, that has largely been done by finding efficiencies in our own processes."

......./.\
...../__.\
.....|===|
.....|..N..|
.....|..C..|
.....|..Y. .|
.....|..T...|
.....|......|
.....|......|
.....|......|
.....|......|
.....|......|
..../|#||#|\
.../.|#||#|.\
../..|#||#|..\
..|../^||^\..|
..|./.^||^.\.|
..|/..^||^..\|
.....(VVV)
......(VV)
.......(V)
........*l*
......( * )
...( % : % )
.( %%:%%)
( % % % % )
(%%%.%%)
%#%#%#%

Sorry, ..had to have a go at transcribing this from another board.

ps My Todgers bigger than yours Porky lol