Member Info for B2HS2L

https://bidstats.uk/tenders/2020/W46/738590768

The Provision of Freight Services for the Supply of Lateral Flow Test Kits for Testing of Covid-19

Legal Justification
The Government has set out the increase of Covid-19 testing capacity as a cornerstone of its strategy to combat rising rates of infection, suppressing community transmission, savings lives and ultimately supporting societal and economic recovery.

Successful validation of an initial range of newly developed Covid-19 lateral flow test kits was completed by the DHSC in September, allowing for orders to be placed to secure a sustainable supply of significant volumes of these products, as a fundamental enabler of the expansion of the testing programme.

The supply of these new test kits is currently limited in the face of very high global demand and consequently it was necessary to contract for supply on an ex-works basis for product manufactured in China in order to secure the required quantity of product and prevent gazumping.

Where product has be sourced on an ex works basis it is imperative that this product is moved at the earliest opportunity to prevent it being sold to higher bidders.

In addition the rising rates of infection in the UK and predicted growth in cases over the coming months, has created an urgent need for these new test kits to support the testing programme in the UK and therefore Air Freight presents the only viable mode for moving product to the UK in time to meet the operational requirements of the testing programme.

In light of these factors the contract was awarded to Air Charter Service Ltd to meet the specific urgent need to transport test kits to the UK, utilising flights from Xiamen, China to London during October 2020.

The short lead time between validating new test kits and needing these kits in the UK to support the national response to a second wave of Covid-19 cases in the UK, justifies the use of direct award under Regulation 32 provision within the Public Contracts Regulations 2015.

Yes Shaun, looking at the spreadsheet we do not have enough info on some of the newer testing centres.
Maybe we should start with confirming from >1 source we are sending COVID-HT to Alderley.
Can you post what you say you saw from GM & consultant at all?

I confess I have been troubled about IT-IS production since I found the article that stated the output had doubled to only 300 instruments a month, and I have not rested to try to get more info on what GM's plans were for improvement.

At that level of output I feared we were going to loose a lot of instrument and assay sales, and possible contract exclusion because IT-IS as a supplier was not able to produce much more.
Now I'm confident we won't loose sales, because action to increase output began in early September.

I used google maps to identify the IT-IS address, and was surprised 20 people could work there.
20 people, - It looked like synchronised breathing would be required.
20 people plus Rishi Sunak and photographer - no way.
I took the rest of today off, - certain Chartwell are working the problem.

Once other nations see the devolved PCR testing coming to fruition, and what the health service will be able to test for, remote from centralised facilities, and to test so quickly, - the mind boggles about what the NPT / Covid 19 and Winterplex demand will be by Christmas and beyond.
This is why I cannot see GM stating an instrument production target that he will be paying Rod Fuerst his bonus on.
++++

A good thing would be to list the news we are waiting for placed in a timeline, just to see how much of it is likely to appear in a Krakatoa RNS (perhaps most of the expected news at once in Jan 2021).
If a Krakatoa RNS is identified, we might see what we might have learned beforehand, and what will still be unknown after, to see what an exit strategy might need to look like, or even if one is necessary.

Tay didn't get the news item he thought would be released last week, so perhaps that will be entering the arena from left field this week.

Have a good week all, - I feel it might be easier to get spiked from now on.

Just drawing together a few dates from last nights discussion re the need to increase output of q16 / q32 / Mygo instruments, for peace of mind and benefit of new investors if nothing else.

*03.08.2020 Rishi Sunak visits IT-IS. Production had doubled to 300 units / month, but date of increase unknown. No visibility of order backlog.

*08.09.2020 IT-IS satisfies a debenture that had been created 10 years previously, prior to which a decision to purchase IT-IS must have occured.

*NCYT already working with Chartwell consultants working with Primerdesign on other projects,

*from the 17th Sep 2020 Half Year Results RNS, discussing production scale-up for the original COVID-19 qPCR test:

"Significant demand and capacity expansion
To meet the unprecedented demand for the test following its launch, Novacyt initiated a programme to significantly scale-up the organisation. The Company engaged Chartwell Consulting, a specialist in rapid process improvement, in early April 2020 to manage and support the planning, procurement and logistics for the capacity increase. This included increasing the Company's own production capacity at the Primerdesign site in Southampton, UK, as well as entering into contract manufacturing partnerships."

From the above it is possible that IT-IS have entered into 'contract manufacturing partnerships' with assistance from Rod Fuerst (IT-IS ex-CEO) and Chartwell Consulting.

*15.10.2020 - RNS: Acquisition of IT-IS International Ltd
GM safeguards supply of units, places Primerdesign orders at highest priority, but has already been preparing to increase output since 8th September; 5+ weeks.
From 15.10.2020 to present is another 3+ weeks, so nearly 9 weeks total.

"Graham Mullis, Group CEO of Novacyt, commented:
"This acquisition ensures that Novacyt is in a strong position to fulfil the growing market demands for rapid near-patient testing of COVID-19, as well as other infectious diseases."

I would imagine GM provided a Rishi Sunak type budget of...'whatever it takes' in order to complete the planned output improvement.

IMO in nearly 9 weeks, NCYT will be close to a large instrument output improvement, with assistance as above.

It is imperative that the increase is achieved, as it appears that for both Winterplex (for q32) and qPCR Covid-19 test (q16 & q32) no supply issues exist.

All new units purchased by PHE etc will contribute to de-centralising the overall testing process, and bringing down time of sample result considerably in care homes hospitals, airports et al.

When do you want the next 700 instruments Boris?

With news of a virus mutation resulting apparently from the passing of COVID-19 from humans to Mink and back again, it might be in Novacyt's best interest to demonstrate to the world customers and medical authorities, that when the next Specificity report is issued, it states that Mink swabs have been tested, and our assay is capable of detecting this virus mutation.
I'm sure this opportunity has not been lost by the Primerdesign team who develop this report, and I look forward to such a statement being included in the next report.
As we are the only test manufacturer who provides this kind of report, we need to be seen to have tested the Mink virus mutation ASAP.

https://twitter.com/PrimerdesignLtd/status/1321007443418271744/photo/1

ShaunP, - No matter thanks I have found the following, from the 17th Sep 2020 Half Year Results RNS, discussing production scale-up for the original COVID-19 qPCR test:

"Significant demand and capacity expansion

To meet the unprecedented demand for the test following its launch, Novacyt initiated a programme to significantly scale-up the organisation. The Company engaged Chartwell Consulting, a specialist in rapid process improvement, in early April 2020 to manage and support the planning, procurement and logistics for the capacity increase. This included increasing the Company's own production capacity at the Primerdesign site in Southampton, UK, as well as entering into contract manufacturing partnerships. The Company also needed to manage suppy chain capacity, which included expanding its key raw material supplier base to develop a long-term and sustainable high volume supply of its tests."

++++
I'll make the assumption Chartwell have got the job.

Hi ShaunP,

If the solicitors were talking on 8th September, I am hoping that GM would have started planning improved production numbers around then.
From your 16:08 post
"His Chartwell consultants team are no doubt providing support at this critical time, especially in the scaling up of manufacturing of the very important q16 & q32 instruments."
Seems like they had an early start, and plans may be more advanced than we think.

Are these Chartwell consultants hired for exactly this type of project management?

https://find-and-update.company-information.service.gov.uk/company/05098475/charges/fXA7nvJIVwuuQXmM09u-VMciT9A

On the subject of IT-IS, here is a companies house link showing that a debenture (as I understand it a loan), from Nat West outstanding since 14.12.2010 was satisfied by IT-IS in full on 8 September 2020.
To me this signals NCYT interest around early September.

Hi Tay,

Whilst we appreciate your posting tonight to deepen our understanding of usage of NCYT tests and testing,
what a number of us would like highlighted if possible is the plans to increase q16 / q32 and MyGo
instrument production. Is there anything available on this subject?
Many thanks for the updates.

I quote you CS:
"I've said it before and I'll say it again.

This is about the 'Big Picture': Fast, accurate, point of care Covid diagnosis."

++++
So where is the AVCT regiment in the battle with this virus?

One other point CS if I may.
If UK Gov / DHSC specified Winterplex, it is reasonable to expect other governments have the same requirement for the same reasons.
As there are few products on the market presently that do what Winterplex does, we are ready to fill overseas orders if and when they arrive.
But that was the kind of research you wanted to interrupt I believe.

Captain Stanley, at 10:58 today you posted:
"Covid/Flu/RSV are very different conditions for a wide heterogenous patient group.
The Winterplex has always looked like a company desperate to maintain market share.
Come March I expect to find them for sale at the end of the aisle at Wilkos along with 'magic' non stick frying pans and vacuum bags to solve all your storage problems."
++++

I felt the following was well suited to respond to your Winterplex comments:

29.09.2020 - Taylor Quant AGM Summary on Twitter
https://twitter.com/TaylorQuant/status/1311206474807476224

Near the end he posted -

"So how has Novacyt managed to stay ahead of the curve, while remaining out of sight by the market.
This was explained and will be their advantage going forward in the years aead.
Novacyt works side by side by the UK Gov, DHSC and AstraZeneca to develop tests that they want.
They have NOT been merely modifying some existing tech and trying to sell it to the Government.
This relationship has ensured the exact specifications and instant rollout of the original Covid test, Covid-HT, EASY-Cov, NPT systems & WinterPlex."

Winterplex exists because UK Gov / DHSC specified it.

I sincerely hope AVCT come good for you, as I'm an investor.
However don't expect to post on this board, drop a few hand grenades and not expect NCYT investors
to fight fire with fire.
It is distracts from information gathering, but that is your aim every time.
I don't normally respond to your posts, - but felt Taylor Quants efforts needed repeating.

Hygiena.com
https://campaigns.hygiena.com/acton/fs/blocks/showLandingPage/a/38777/p/p-0058/t/page/fm/0

This is a neat way of providing access to a catalogue on screen.

Molecular PCR Pathogen Detection.

On page 45 & 46, the BAX System X5 (a q32 equivalent instrument) is discussed in terms of Assays designed to detect DNA based (remember DNA) pathogens in food samples.

On page 45
1 Neat Video
2 An App called a BAXApp allows the review of BAX system results on your smartphone or tablet with this free App.
So receipt of remote analysis results is achievable via BAXApp.
Geneme uses YOTI to distribute test results.

So if Hygiena.com have this facility, perhaps it won't be long before IT-IS make it available to all customers.

Page 46 displays:
Speed - Sampleprep, amplification, and end point detection in under 5 hours.
Confidence - Built-in positive control for rapid, reproducible results.
Ease of Use - Does not require advanced training or skill level.
Convenience - Prepackaged PCR tablets for consistency, stability, and reduced operator error.

Here is a level of innovation GM would be proud of.
If it is possible to detect virus RNA with PCR tablets then we might expect this feature when the q16 / q32 and MyGoPro is next updated.
++++

Question: Whatdoes a MyGoProESR do?

From: https://www.labortechnik.com/en/mygo-pro-esr/real-time-pcr-cycler

"MyGo Pro ESR
Extended version of MyGo Pro.
Realtime PCR with calibrated dyes like FAM, HEX, ROX, CY5, CY5.5... .

MyGo Extended Spectral Range (ESR) with solid red channel.
Other calibrated dyes are available on request."

This is IT-IS's latest innovation, and is what Rishi Sunak was investigating in the press releases.
Have a great weekend team.

https://londonlovesbusiness.com/armed-forces-start-mass-testing-in-liverpool/

2000 armed Forces personnel to test in 6 centres in Liverpool.

"The personnel will be able to deliver hundreds of thousands of tests, and soldiers were seen entering Pontins Southport Holiday Park on Thursday."

Great for Liverpool, - lets see if we can 'clean up' the city.

We know production doubled to 300 / month, but we do not have sufficient view of the market requirement from a number of world wide sales networks.
We can say pre COVID-19 in Feb 2020, that 150 q16/q32 instruments per month was perhaps sufficient to meet demand, but we cannot say what the order backlog was at this time.
From March 2010 things would have warmed up considerably, but all we know is that doubling the original production of 150 instruments / month was insufficient, because Primerdesign bought the company in October 2020 partly because there was insufficient instruments to meet their orders.
The decision to buy the company may have come in September, and due diligence etc took sale into October.

The decision to DOUBLE production (when?) implies a large increase in orders sufficient to justify this decision.

It is clear these instruments are being hand made, configured and QC'd manually by a team of 20, and GM wants this process revved up.
He has incentivised the previous director to increase production, - but with what size budget?
If it is large, - does that preclude entire outsourcing?
I mentioned before that a local robotics company seemed to have links with IT-IS, and we will have to wait and see whether it forms part of the solution.

One retailer not in the spreadsheet (I believe)
LAB MARK a.s.
Pod Cihelnou 23
161 00 Praha 6-Ruzyne
Czech republic

Retailing MyGoPro / MyGoMini

+++
http://www.genetixbiotech.com/images/pdf/PalmQ-Mini.pdf
Retailing the q16 rebadged as 'PalmQ-Mini', already in spreadsheet,
but does not appear to retail q32.

An example of a company selling a rebadged clone.

++++
Cold Spring Biotech Corporation China
https://translate.google.com/translate?hl=en&sl=zh-TW&u=http://www.csbiotech.com.tw/product_list3.aspx%3Fprd_id%3D114&prev=search&pto=aue
Retailing MyGoPro / MyGoMini

Had to use google translate to get to what was being sold here.
How many other websites not using western script are selling q16 / q32 clones?

To identify the total q16 / q32 instrument sales requirement, we need to be sure we have visibility of the q16 / q32 instrument as sold under other names:

Pentabase Basecycler (Denmark) - The BaseCycler™ Real-Time PCR Instrument provides precision and speed in a convenient format.
The use of high performance Peltier elements combined with solid silver blocks produce World-leading thermal uniformity for sensitive quantitative PCR and optimal High Resolution Melt (HRM) analysis.
https://www.pentabase.com/product/basecycler-real-time-pcr-instrument/
Pentabase sell MyGo mini and Pro, so the spec of the BaseCycler is probably different. - (Solid Silver Blocks?)
The BaseCycler runs with a special version of MyGo Pro software.
++++
Hygiena USA
941 Avenida Acaso
Camarillo, CA 93012
USA
https://www.hygiena.com/bax-x5.html#specifications

About Hygiena
Hygiena delivers rapid microbial detection, monitoring, and identification solutions to a wide range of industries, including food and beverage, health care, hospitality, pharmaceuticals, and personal care. Utilizing advanced technologies and patented designs, Hygiena provides industry-leading ATP monitoring systems, PCR-based foodborne pathogen detection, DNA fingerprint molecular characterization systems, allergen tests, environmental collection devices, and more. Hygiena is committed to providing customers with high-quality innovative technologies that are easy-to-use and reliable, backed by excellent customer service and support. Headquartered in Camarillo, California, with offices in Wilmington, Delaware, the United Kingdom, and China, and over 80 distributors in more than 100 countries worldwide, Hygiena products span the globe.

2015 - Smaller BAX® System X5 provides PCR detection to more food companies (similar to q32)

Over 100 distributors world wide:
https://www.hygiena.com/about-hygiena.html

https://www.hygiena.com/oem-manufacturing.html - OEM info.

https://www.hygiena.com/food-and-beverage-sales/europe-middle-east-and-africa.html - Hygiena International (Watford) office

++++
https://www.azuragenomics.com/mygo-pro-real-time-pcr-instrument.html
Retailing a product called MyGo Pro ESR (Rishi Sunak seen peering into one in press releases)

Azura Genomics Inc.
44 Commercial St. Unit 1
Raynham, Massachusetts 02767
USA
Retailing MyGoPro / MyGoMini, so what does the ESR model do?

Well with the Optigene credentials spoilt as described, I would think they would accept help to sort it out quickly, and the govnt would want a quick fix too. So I'm keeping options open that the vacancy is for this purpose.

Hi Shaun, - I'm unsure whether this article has appeared before, but thought parts of it would be better off in your spreadsheet.

https://www.dailymail.co.uk/news/article-8865733/1-3bn-High-Court-challenge-lucrative-Test-Trace-contracts-launched.html

NCYT recently advertised a vacancy for a PCR assay design scientist, with part of the job description stating that the successful applicant would need experience in designing and validating assay's and lamp isothermal PCR.

Perhaps NCYT are now working with Optigene to sort out the LAMP assay issues?

Totally agree Wilson.
All I am saying is that now we have acquired IT-IS, we have to spend more on increasing output for the 'land-grab'.
Every minute counts, - hoping there is a real good plan.

Now we have bought IT-IS, I think we are spending cash on increasing the output of the q16 / q32vproduction lines risehall, and it's difficult to know how much that might be. The pressure to get the job done soonest may also push costs higher.