Ekf Diagnostics Share Discussion Threads

[wan] 26/4/2021 06:22

Probably not much at the moment, hence it 'could' positively impact sales if it becomes authorised and fully validated etc, hence it was only food for thought.

Currently ATM can be ordered for research use only, and an initial EUA using PrimeStore® ATM was filed in early September.


Background - In an interview in September last year, Longhorns President, Jeff Fisher, told an interviewer that they were working with one of the largest diagnostic companies in the world to add a Longhorn product to their point of care test that differentiates between COVID-19 and flu (not sure that that reference is to ATM though).

ATM is apparently capable of stabilising proteins and antibodies for rapid, highly sensitive, testing.

That interview statement, which may now be obsolete, is stated at about 20 minutes in -


So, and to reiterate, it provides only food for thought at this stage.

[shanklin] 25/4/2021 09:30

wan, so what does this all mean for EKF sales?

[wan] 24/4/2021 09:26

I am back in food-for-thought mode and I am extrapolating my post 1763 regarding PBS.

I began by saying that lateral flow tests are dependent upon a number of factors in terms of performance, not least by the preparation/make up of the buffer solution. This is quite often in the form of a Phosphate Buffer Saline (PBS), which is used for the sample dilution (and of course sample collection/protection). So, the buffer solution and composition represent a critical element of the test, which can also affect the accuracy of the test. I am no expert, and that statement may not be entirely correct. However, I don't think I am too wide of the mark in terms of the buffer solution being a critical element.

PrimeStore ATM (currently off the radar) appears to have gone on the backburner as there has been no mention of it during the recent presentation or in AR, but I am not so sure that means that it is not being progressed.

Given the range and mix of testing being deployed and importantly in development to address Covid-19, especially in terms of rapid near patient testing (including certain PCR), and given the fact that PBS (manufactured by EKF) is safe from a consumer and disposal perspective (does not contain Guanidine or Ethanol), and is described as a low cost alternative to PrimeStore MTM, where does that leave PrimeStore ATM (which is also presumably safe being free from Guanidine or Ethanol i.e. would be suitable for self-testing)?

So, first we have to consider that the PBS product is almost certainly for molecular testing (low cost 'alternative' to MTM). And whilst the ATM product (still only available for research use only) states it's optimised for molecular testing; descriptions suggest it will enable improved (revolutionise) rapid and near patient testing.

We know from a previous article that Longhorn said ATM would enable extraction-free PCR testing. And although Longhorn currently describes ATM as being optimised for Molecular testing, it also describes it as offering highly sensitive antigen testing capabilities (also known as rapid tests). This description (and my interpretation) is further validated by Thermo Fisher, who describe ATM as an "Analyte Transport Medium for optimized molecular testing while preserving and stabilizing proteins and antibodies for rapid testing (no Guanidine or Ethanol)."

So, it appears that both PBS and MTM will continue to serve different aspects of the molecular (PCR) sample collection and testing market, including where sample collection is more demanding in terms of logistics/refrigeration etc. But bearing in mind that the buffer solution used in certain rapid tests (including lateral flow tests) is also described as the extraction buffer, and that ATM has been described as eliminating the need for extraction, ATM could therefore improve the test procedure, but also (apparently) enable highly sensitive testing.

The terminology that EKF Diagnostics is providing the picks and shovels to the Covid-19 testing opportunity, might take on an even wider meaning, especially as the products will likely have utility beyond Covid-19 e.g. flu testing/differentiation and possibly many other applications/diseases/specific viral antigens.

[wan] 23/4/2021 09:08

Food for thought -

Given the remarks above from Danaher regarding their Cepheid GeneXpert platform, readers might want to consider that laboratories have independently validated PrimeStore® MTM through a wide range of high throughput platforms, including Cepheid -

(scroll down page) -

Furthermore and as background, Longhorn previously announced that their PrimeStore® Molecular Transport Medium significantly improves the Cepheid Xpert® MTB/RIF sensitivity in crucial low copy samples -

What is also quite additionally interesting, and a notable advantage in my view, is the following -

Q: Can I take an aliquot from the PrimeStore MTM
solution and directly conduct a RT-PCR assay
without initial nucleic acid extraction?

A: Due to certain components of the PrimeStore MTM
solution, you must first undertake a nucleic acid
extraction process before you conduct a RT-PCR assay.
However you can place a sample from PrimeStore
MTM into the Cepheid GeneXPert cartridge along with
the Cepheid PBS solution without first performing an
extraction step.

[mirandaj] 23/4/2021 08:57

For speed - copy of Annual Report:

[wan] 23/4/2021 07:52

Investors will already appreciate that under the new multiyear global supply contract announced by EKF to support its partner's world-wide staff testing, that EKF expects orders from the expanded agreement to reflect EKF's increased contribution will contribute materially to 2021 performance and beyond. The contract has an initial term of two years after which it renews automatically on a monthly basis.

The main thrust being that testing will continue through 2021 and 2022 at a minimum, with perhaps prospects for the addition of extension and possibly other test requirements.

I note the following excerpts which solidly counter the fact that certain companies are expecting testing to decrease, and not least that the flu season may add materially to testing requirements -

Demand for Cepheid SARS-CoV-2 Point-of-Care Tests Expected to Continue Through 2022
Apr 22, 2021

In the first quarter, Cepheid shipped 10 million test cartridges – half of them were the firm's COVID-19-only test, and half were the company's four-in-one test for SARS-CoV-2, influenza A/B, and respiratory syncytial virus, Blair said. Cepheid has continued ramping up its capacity and expects to ship 45 million tests in 2021, up from the firm's previous estimate of 36 million for the year. Blair said the firm also expects $2 billion in COVID-19 testing revenues in 2021.

According to Blair, COVID-19 testing will be endemic and Danaher believes near-patient and point-of-care testing will continue to be a major player for a long time. "While some folks are talking about 2021 being a peak year for testing for the market," he said, "we believe that we'll do roughly the same number of tests in 2022."

Blair also said Cepheid expects the number of tests it will ship to grow by 1 million each quarter, shipping 11 million in the second quarter and increasing from there. He added that Danaher across all its businesses has invested consistently over the past 18 months to expand its capacity and continues to do so.

The mix of tests will also change throughout the year, he said. While the mix for the first quarter was even, the summer months will likely bring higher demand for the SARS-CoV-2-only test, with 80 percent of test orders for the single analyte test, Blair said. As the flu season ramps up in the third and fourth quarters, he expects the mix to even out again.

Although some experts have predicted a decline in the demand for SARS-CoV-2 testing as vaccines roll out across the world, Blair said the process will likely take years, during which testing for COVID-19 will still be necessary. He added that the effectiveness of vaccines is on a continuum and that breakthrough infections in vaccinated people have already been seen, so testing will continue at the point of care and in near-patient settings. Based on conversations with customers on their outlooks for the next two years, Blair said Cepheid expects to maintain its current level of test shipments.

Growing placements of Cepheid's PCR-based GeneXpert platform, which have increased by more than 40 percent since the beginning of last year, have allowed the company to have a "leading presence" at the near-patient setting and "uniquely positions the business to support customers' testing needs not only for COVID-19, but beyond the pandemic as well," he continued.

Full story -

Roche sees strong Q1 sales in COVID-19 tests, routine diagnostics
Published April 21, 2021

However, Schinecker last month warned at a diagnostics investor day that lower viral loads present in vaccinated individuals could lead antigen tests to deliver more false negatives. As a result, he made the case that as COVID-19 cases fall and vaccinations rise, turnaround times and viral loads could drop, tipping the balance in favor of PCR.

Schinecker said Wednesday he doesn't provide guidance on coronavirus testing given the unknown variables impacting the market, including the vaccine rollouts and the emergence of variants. However, he insisted that "people will be testing for quite some time" because "different parts of the world will not have achieved herd immunity in terms of vaccination and school children will not be vaccinated most likely."

Nonetheless, Schinecker predicted that second-quarter COVID-19 sales "will be strong" continuing into the third quarter, adding that the company is "much stronger than we had hoped for" when it comes to non-coronavirus routine testing.

Full story -

With large diagnostic player recently reporting, another interesting fact was that they are reporting that their base businesses continued its recovery to near pre-pandemic levels. Indeed, as EKF indicated, they should benefit in this regard too.

[rivaldo] 23/4/2021 07:29

It's pleasing that shareholders will be able to join the forthcoming AGM on 19th May (and submit questions, albeit before 17th May):

[wan] 22/4/2021 10:20

srichardson...Along with the fact that EKF will also be receiving 2,677,981 shares in Verici, currently valued at circa £1.7m

[srichardson8] 22/4/2021 09:26

Most of you will be aware that Renalytix - in which Mr Mills holds a 12.77% stake - has made a very important and positive announcement today regarding an agreement to supply US public service bodies with access to its kidney diagnostic. EKF itself still holds 1 million shares I believe and as I write the RENX price has moved up to just under £11.

[wan] 22/4/2021 08:15

Charlieej...Indeed I had duly noted, hence I am seeing more from the demand aspect at these levels, than the sale itself.

Given the recent upgrade for 2021, with potentially more to come, we know that EKF has come onto a number of new radars recently, so lets see what materialises in the fullness of time in terms of holding announcements.

[charlieej] 22/4/2021 07:59

Sorry should say vox markets

[charlieej] 22/4/2021 07:58

Wan if you listen to the box markets interview with mills in November at 24:50 he states that he will be forced to sell as EKF will be taking up too large a % of the portfolio so I don't see his sale as being that negative. What I like is the market sucked it up at 80p

[wan] 22/4/2021 07:47

It will thus also be interesting to see if we get another holding announcement in due course e.g. a new significant shareholder.

[wan] 22/4/2021 07:45

I note the Chairman has sold nearly 4m shares.

On the one hand one could interpret that as a negative, but it does demonstrate there is strong demand at these levels, and given the prospects, I am not surprised there is good demand. Not least to also gain exposure to the EKF/Mount Sinai Partnership. This agreement and relationship provides EKF with advanced access to innovative commercial opportunities and presents significant opportunity for EKF to collaborate on ground breaking medical technologies that can be spun off and proceed down the IPO route.(which Chris Mills still has lots of exposure to!).

I do keep tabs on a number of developments, and I also noted the following recently -

New York, NY (April 19, 2021)

Icahn School of Medicine at Mount Sinai Unveils New PhD Concentration in Artificial Intelligence and Emerging Technologies in Medicine Preparing future biomedical researchers with the necessary skills to tackle the field’s escalating complexity

“The transformative impact of artificial intelligence and other emerging technologies in medicine is just beginning. We are now on the frontier of more accurately identifying the indicators of disease and opening up new vistas for treatment of illness in real-time,” said Dennis S. Charney, MD, Anne and Joel Ehrenkranz Dean of the Icahn School of Medicine at Mount Sinai and President for Academic Affairs of the Mount Sinai Health System. “Establishing this concentration is part of an expanding institutional commitment at Mount Sinai to advance this critically important area that will be a game-changer for physicians in their ability to provide better diagnose and care for their patients.

“The Artificial Intelligence and Emerging Technologies PhD concentration will create vital new opportunities to train the research scientists of tomorrow in assimilating innovative, cutting-edge technologies to advance drug discovery and a variety of clinical applications” said Marta Filizola, PhD, Dean of the Graduate School of Biomedical Sciences and Sharon and Frederick Klingenstein/Nathan Kase, MD Professor of Pharmacological Sciences at Icahn Mount Sinai. “Artificial intelligence and several other powerful technologies such as medical devices, robotic machines, and sensors are paving the way for a new era of biomedical research, offering unparalleled opportunities to improve human health. This new training area, along with other similar initiatives, is placing Mount Sinai at the leading edge of this emerging scientific field to enhance health and well-being of people everywhere.”

The answers to many fundamental questions in medicine and biology currently lie buried inside data collections that are too large and heterogeneous to be stored, curated, analyzed, and visualized by traditional approaches. “Future biomedical researchers will need to be equipped with the necessary skill sets to tackle escalating complexity in medicine,” said Thomas J. Fuchs, DSc, Icahn Mount Sinai’s newly appointed Dean of Artificial Intelligence and Human Health, Co-Director of the Hasso Plattner Institute for Digital Health at Mount Sinai, and an internationally renowned scientist in the field of computational pathology. “Not only will this new generation of professionals need to receive foundational education in the use of information systems, but they will need to learn how to develop and interpret predictive diagnostic and therapeutic models using a variety of machine learning tools based on statistics and probability theory, drawing upon quantitative fields such as computer science, mathematics, theoretical physics, theoretical/computational chemistry, and digital engineering.”

Full press release -

[shanklin] 21/4/2021 12:57

wan, Will read your posts with interest, thank you.

Must admit I was completely bemused by Avacta suggesting a 1% rate on false positives was some sort of fantastic results.

With one in a 1000 (say) of the UK population currently having Covid, in a football crowd of 50k, that's 5 people with Covid but 500 people who won't be let into the ground... ...even assuming they can test 50k people that quickly.

Just seems complete lunacy to me as they will no doubt quickly find out at the World Snooker

[wan] 21/4/2021 12:04

The following has been on my mind for a while and provides further food for thought -

Lateral flow tests are dependant upon a number of factors in terms of performance, not least by the preparation/make up of the buffer solution. This is quite often in the form of a Phosphate Buffer Saline (PBS), which is used for the sample dilution (and of course sample collection/protection). So, the buffer solution and composition represents a critical element of the test, which can also affect the accuracy of the test.

Recall that EKF has commenced production of PBS for collection kits -

Additional production lines for Phosphate Buffered Saline (PBS) established Q1 2021 at Boerne, South Bend, Barleben and Cardiff sites

Orders of PBS (phosphate-buffered saline) to exceed £2.4m in Q1
• Two-year global supply contract with a major international brand customer for regular staff testing and home-use
• Manufactured at sites in the US, UK and Germany



For reference -

30 March 2021
Trading update &

Significant expansion of supply agreement for COVID-19 sample collection kits

Private sector partnership with EKF for global staff testing programme

Under this new multiyear global supply contract, EKF will now support its partner's world-wide staff testing initiative, with orders being fulfilled from EKF's production sites in the UK, Germany and the United States. The Company expects orders from the expanded agreement to reflect EKF's increased contribution to their partner's global testing programme, and therefore this agreement is expected to facilitate future orders which will contribute materially to 2021 performance and beyond. The contract has an initial term of two years after which it renews automatically on a monthly basis.

Further to the announcement on 12 January 2021 , trading in the first quarter was materially ahead of management expectations. With subsequent orders under this expanded global contract expected to make a considerable contribution throughout the current financial year and beyond, the Board is confident that trading for the year ending 31 December 2021 will be significantly ahead of already upgraded management expectations.


There is obviously differences between PBS for sample collection/collection kits and that for a lateral flow test, but I had been wondering about the difference in terms of the manufacturing processes for each, which don't seem miles apart from my layman perspective, especially as the required lab facilities in terms of sterile environment/product are in place. It would certainly fit well with the supplying of the picks & shovels terminology.

Anyway, as I said at the beginning, it's only food for thought at this stage.

[wan] 21/4/2021 09:58

An important point being that a positive lateral flow test leads to the requirement of a PCR test, which can then also be tested to differentiate between flu and COVID-19.

But in any regard, clearly SBI are intent on serious expansion and acquisitions in both the UK and the US, and with its upgraded US lab facility nearing completion, in my view it is very likely to positively impact EKF's sample collection business.

[rivaldo] 21/4/2021 09:13

There's an excellent write-up by the Private Punter (hastings) on SBI just published- here's a direct link:



Posters here will know of the relevance to EKF - here's a particularly specific reference with comments from SBI's Chairman (for clarity I also hold SBI, which imo is very good value as per the article):

"Although PCR testing remains the gold standard The Chairman says “the UK Government has increasingly been using the lateral flow tests, which really aren’t that good, but there are now new tests coming through that give a high 90% sensitivity rate.

We have a relationship with one of these companies and we are going to be working with them to release that across the UK”.

There is also a mention of EKF (covered here on the blog) with which SBI appears to have a close relationship and LeCoque points out that the former now has an antigen test. “Nobody seems to care about antibody testing right now, but we think that might well shift once the vaccine roll out goes forward, so we are ready to go with it. Although we haven’t launched that yet, we believe there will be demand, so we will be ready to do that as well”."

[wan] 21/4/2021 06:00

Edit to the above post - Link to EKF and the attributes of PrimeStore MTM

[wan] 21/4/2021 05:52

An interesting interview with Luke Daum, chief scientific officer for Longhorn Vaccines and Diagnostics, where he foresees a very large increase in testing to differentiate between flu and COVID-19. I also note he describes a more simple and less invasive form of sample collection.

Infection Control Today
Foundation Laid for At-Home COVID-19 Testing
April 20, 2021
Frank Diamond

All—or, at least, most—eyes are on COVID-19 vaccinations these days and things seem to be going well in the United States along those lines. But remember testing? In those dire months of surges before the vaccines came along, it was all about testing. COVID-19 testing will be around for a long time, predicts Luke Daum, PhD, the chief scientific officer for Longhorn Vaccines and Diagnostics, a company that makes at-home COVID-19 tests. Daum tells Infection Control Today® that “we need to all be vaccinated. I’m a big proponent for the idea that everybody should get vaccinated as quickly as possible. But there is another way to get to the herd immunity stage, and that’s through natural infection. And that’s where testing comes in.”

ICT®: Wouldn’t it be easier for somebody at home to take an at-home test and get the reading themselves and then take the appropriate steps? What the question is asking is that the way you’ve defined, it seems like you have to put the sample in the mail. We all know what’s going on in the mail these days. And there might be some time between when the sample is taken and when the sample is diagnosed.

Daum: You just hit the nail right on the head. That’s the critical window. That’s the window in which you want to ensure that the sample is inactivated safely so that the people handling the package and getting it from point A to point B are not going to become infected by a leaky box. You also want to ensure that the stability of the RNA and the DNA in that collective tube from that swab is preserved in such a way that the integrity is there, regardless of temperature extremes, or delays in shipping, which happens all the time.

ICT®: Some kind of courier service would be involved, I guess?

Daum: Yes. A lot of groups now are collecting in medias that inactivate the sample in such a way that you don’t have to tick infectious disease boxes, and they have contracts established with UPS and FedEx, the regular couriers who transport those samples to a diagnostic site retesting.

CT®: Tell me if this metaphor works. We’ve done some stories about how pharmaceutical companies do not really dive in when it comes to creating new antibiotics because it’s not cost-effective. They’d be spending a lot of money for something that will eradicate what they’re spending it on. Once they eradicate the disease or really contain it, there goes the demand. Do you see something like that? Is that a metaphor you can use for at-home testing or COVID-19 testing in general? Or will it be around for a long time?

Daum: I think for sure. And I think as we get into the fall…. One thing that I can say is through social distancing and wearing our masks, we’ve done a really good job with regards to that. And the case in point to that is influenza. I came out of a military background where we did strain surveillance for influenza viruses. I have never seen an influenza season not exist like the one we just went through. No cases in Texas, very few cases in the United States in general. All probably attributed to the fact that we’ve done a good job of social distancing and wearing masks. Having said that, as we approach the fall, the masks are starting to come off now. People are starting to get vaccinated and coming out of their homes. People are getting more comfortable. They’re getting cabin fever. They want to get out. Expect this fall in September, October, November, for influenza to re-emerge as a concern. And it’s going to be critical, as we move into that season, that we differentiate between COVID-19 cases and influenza cases. Testing is going to be critical. For the same types of PCR tests that we use for identifying COVID-19, we have similar tests for influenza. And many of them can be performed in a multiplex fashion at the exact same time. What I mean by that is one collected sample from a patient can be used and tested at the lab to test for multiple pathogens, including Influenza A, Influenza B, and COVID-19.

ICT®: You just talked about the possible reemergence of the flu next fall because theoretically people are not going to be a social distancing as much and not wearing a mask as much. Will that be helpful for health care providers to separate who has the flu from who has COVID?

Daum: That’s why it’s going to be important. And that’s why I advocate sample collection. And again, that’s what our company is about. I know we’re not speaking about that here. But sample collection is the first step in ensuring that a sample is preserved, that the RNA from these viruses and DNA from bacteria and other viruses are preserved and collected in these periods in such a way that they can be used to test for COVID-19. But then you can go back to the same sample and test for all the other respiratory pathogens.

Full interview -

Test for COVID-19 and flu from the same flocked sample swab

A key feature of PrimeStore MTM is that it allows lab teams to process multiple tests from a single sample that has been inactivated and stabilized in PrimeStore MTM.

[wan] 20/4/2021 10:24

Yesterday I expressed a view regarding home-use testing (via postal, or courier, or via certain logistical delivery/collection service!) as also sitting quite well with the digital health/telehealth opportunity. So perhaps EKF could indeed become an important supplier of the picks & shovels in the form of numerous home-use tests that will also compliment digital/telehealth, not to mention pandemic/epidemic preparedness.

The following, which is still in the planning phases of this proposed procurement,
is another example of where some tests are heading in terms of where the actual test takes place or sample is taken, and is another example of how such testing might sit within digital health options -

Packaging for NHS Test & Trace
A Prior Information Notice
by DEPARTMENT OF HEALTH AND SOCIAL CARE

Published
19 Apr 2021

Total Quantity or Scope
NHS Test and Trace is seeking to procure the packaging requirements for the kitting of test kits specifically for the Home Channel, with continuity of supply being fundamental during this transition period.The ambition of NHS Test and Trace is to ensure that everyone who needs a test in the UK has access to one.

The Home Channel is one of a number of convenient channels helping to facilitate Covid-19 testing.

To support the Home Channel, NHS Test and Trace are looking to standardise the packaging requirements for the test kits to move to a more effective and economic packaging solution that can protect test kits in transport to homes as well as meeting the legal requirements to safely transport samples returned to test laboratories.

This packaging also needs to be handled efficiently at laboratories to maximise testing throughput.

Based on lab and end user feedback Test and Trace have designed a packaging solution to meet the requirements of the Home Test Channel.

It includes an individual test kit cardboard box, a tamper seal, a double grip seal leakproof bag and an absorbent sheet to protect against leaks. The volume is anticipated to be approximately 2.4M individual test kits, kitted per month.

We intend to run an initial supplier engagement event including a Webinar and RFI (prior to the issue of the tender) on Friday 23rd April at 10am.



So, it will be interesting to see how this new NHS Home Channel evolves.

Those who manged to listen to the presentation meeting, might recall Julian's remarks about the recognition of the quality of EKF's assembled Covid-19 testing kits and that that is leading to new business opportunities.

[wan] 20/4/2021 08:48

Shanklin...Recall the point I raised yesterday that EKF is supplying the picks & shovels to the Covid opportunity -

Source BioScience to use PrimeStore MTM kits for COVID-19 testing service

EKF Diagnostics Holdings plc (AIM: EKF), the AIM quoted point-of-care business, announces that it has signed an agreement with Source BioScience UK Ltd (“Source BioScience”), which provides Laboratory testing services for the NHS, to supply PrimeStore MTM, a novel patented sample collection device, to be used for its growing COVID-19 testing service.


That is already been applied elsewhere too, e.g myhealthchecked/boots etc, but I also think there is a very good chance of securing other business, including opportunities outside of and beyond Covid testing.

[shanklin] 20/4/2021 08:24

As an EKF novice it is quite difficult to assess EKF's competitive position in a market which many companies will:
- attempt to win a chunk of PHE's 15Bn as per post 1754
- be offering super-duper mobile diagnostic centres

Obviously there is a lot for EKF to target but no certainty as to how much business they will win... ...or perhaps you guys are more certain.

EKF does not have to win that high a proportion of all this for it to be transformative for the company.

[wan] 20/4/2021 08:15

Re testing, it's also worth taking on board EKF's 'global' roll-out of their point-of-care CE marked, FDA CLIA-waived STAT site® WB analyser, which is underway.

Staying with testing -

Covid-19 Mobile Testing laboratory services available for large volume, fast testing to meet requirements. Whether it is for a sporting events, theatres, concert venues or television studios; we are able to offer a tailored solution.

[mirandaj] 19/4/2021 21:34

FYI - 18th April



Description

Lot 4 – Clinical Laboratory Diagnostic Testing Services is intended to enable access to Clinical Laboratory Diagnostic Testing Services using extant techniques and allow for the addition of new techniques or existing techniques utilised in a new manner in the future. The Lot is to ensure that there are consistent and affordable provision of high quality, safe and compliant Testing Services which should be delivered efficiently and effectively to support wider clinical services. Please note that this Award Notice is for Lot 4 however the Framework Agreement encompasses the following four lots: - Lot 1: Diagnostic Goods and Services - Lot 2: Research and Development Goods and Services - Lot 3: Manufacturing, Product Development and Commercialisation - Lot 4: Clinical Laboratory Diagnostic Testing Services