Ekf Diagnostics Share Discussion Threads

[wan] 24/2/2021 07:47

Sounds familiar -

Siemens Healthineers offers lab-based antigen test for high-throughput analyzers and expands Covid-19 test capacities
Erlangen, Germany

2021-02-23

The Siemens Healthineers SARS-CoV-2 Antigen Assay (CoV2Ag) offers an accurate, high-capacity testing solution to diagnose COVID-19.

CoV2Ag offers testing for current infection worldwide on a widely available installed base of automated immunoassay analyzers.

The fast time-to-result includes a pretreatment process to inactivate the virus as a safeguard for laboratory staff handling the samples.

Siemens Healthineers announced today the company's laboratory-based SARS-CoV-2 Antigen Assay (CoV2Ag)1 obtained CE Mark and is now offered for the Atellica® Solution and ADVIA Centaur® analyzers, widely available in laboratories worldwide. The test has been submitted to the FDA for Emergency Use Authorization. The antigen test detects the nucleocapsid antigen and has been designed with five monoclonal antibodies with the objective to maximize its sensitivity to both current and future SARS-CoV-2 variants. It also offers a leading time-to-result for lab-based antigen tests, making it an ideal tool to test large quantities of patient samples quickly. Such testing could be deployed at on-site collection centers for hospital staff, patients and visitors, remote collection facilities for large scale testing of local populations or in dedicated, pop-up labs at airports or universities. In addition to speed and reliability, the test is further characterized by a pretreatment process that helps protect laboratory staff from the virus. It inactivates the virus without compromising the quality or validity of patient test results.

Full release -


Is the pre-treatment process a Longhorn product? I am not sure at this stage, but what we can ascertain is that one of the largest diagnostic companies in the world, thinks that inactivation is an important part of the testing process (watch this space!). And provides food for thought while we await further details of how PrimeStore ATM will be utilised in antigen testing, and whether any Longhorn products manufactured by EKF make their way into rapid tests.

[wan] 23/2/2021 09:47

Edits to the above post....just a few tweaks and specifically that PrimeStore MTM is 'already' FDA approved.

[wan] 23/2/2021 09:30

Apparently, there is a view that testing will peak in Q1, so I guess that's why we have a pullback, along with most stocks associated with testing.

The next thing the market will be trying to assess is for how long and at what level testing, including surveillance and genomic testing, will last.

Chris Whitty (UK Chief Medical Officer), stated yesterday that Covid-19 will be with us for at least the next few winters.

So, as we enter the autumn periods respectively, another key point will be testing to differentiate between flu and coronavirus. Not to mention that an important aspect of testing, will be that 'any type of test' is 'not' impacted by mutations (the FDA has just release guidance in this regard).

In my view, PCR testing will endure for all of 2021 and into early 2022, so it's just a case of at what level. And importantly, the effect from the withdrawal of EUA's, that could focus demand onto PrimeStore MTM (which is 'already' FDA approved!), including (given the attributes) certain intuitions choosing to use only PrimeStore MTM, especially with regard to both surveillance and surge testing.

And then how much surveillance testing is conducted globally, which is being ramped up significantly, and is now likely to be required forever!

Rapid testing, and in that I am including rapid PCR testing, appears to have potential for very high volumes to at least be maintained, and possibly to grow significantly. In this regard, apart from Longhorn implying that they have been working with a large diagnostic player to use certain Longhorn ingredients to address rapid testing, we don't have much else to suggest EKF could enter the rapid Covid-19 testing market, but I am optimistic, given how EKF and Longhorn has been put on the map so to speak, that new products (including ATM) might give further exposure beyond PCR testing. Time will tell, but as a nod to some, personally I wouldn't want to be either short, or indeed out of EKF if that gets announced!

[tongosti] 23/2/2021 09:06

Yeah yeah yeah. The tape seems to indicate that if a strong close below 63 takes place, then the next step will v probably be another leg south to 45 level.

[mirandaj] 19/2/2021 13:41

Time lapse video of fit out at warp speed

[wan] 19/2/2021 09:56

Rivaldo...Thanks for the SBI input, especially the significant increase in PCR testing since January. I guess that that fits well with the last Trading Update from EKF, which also stated -

"Trading in the core business in the final quarter has continued to improve significantly and ongoing demand for the PrimeStore MTM COVID-19 sample collection device remained strong through to the end of the year and will continue to do so into the first quarter of 2021."

"With continued strong performance in the core business and a number of indicative orders for PrimeStore MTM for the first quarter 2021 that are likely to be realised, the Board is confident that performance for the first quarter of 2021 will be materially ahead of current management expectations, and the first quarter of 2020."


SBI's significant increase in testing appears, on the face of it, to endorse EKF's confidence in outperforming expectations.

[wan] 19/2/2021 09:12

Recall that back in September, I highlighted that Longhorns President confirmed in an interview that Longhorn was working with a diagnostic company to add PrimeStore MTM/ATM (or other certain ingredients) to their point of care test that differentiates between COVID-19 and flu.

Also, I raised a question at an EKF zoom meeting regarding PrimeStore being compatible with saliva samples, which CEO Julian Baines said they were working on. And at the time I reported that Julian's answer gives me hope that a rapid test (quicker than current PCR) that specifically utilises PrimeStore (MTM or ATM) might not be too far off.

And that in the same meeting, unfortunately my follow-up question regarding current and emerging LAMP test compatibility, appeared to run out of time for answering.

And not to mention that, in any regard, that samples collected in transport media that does not inactivate the virus, are therefore still considered infectious and must be transferred in a biological safety cabinet and inactivation etc, significantly slowing down the work flow, which hardly seems compatible with mobile/pop-up laboratories.

[rivaldo] 19/2/2021 08:33

Good spot wan. As a holder of SBI I've also given EKF a small plug on that bb :o))

I note that today's RNS states that "SourceBio has processed approaching 1,000,000 COVID-19 antigen RT-PCR tests for the DHSC and the NHS".

SBI's 18th January trading statement noted that they had carried out 400,000 such tests.

Which implies that in the month since then, SBI have carried out 600,000 new tests....which I assume will have utilised PrimeStore transportation devices?

[wan] 19/2/2021 08:14

What I can confirm is that one of the components contained in PrimeStore MTM is guanidine isothiocynate. And I note that in the Rapid Evaluation Report that the analytical sensitivity for the LamPORE assay was evaluated using a blinded panel of guanidine isothiocynate inactivated SARS-CoV-2 virus.

[wan] 19/2/2021 07:59

Recall that an inactivation step is required for PCR type tests. However, this inactivation process is not required when using PrimeStore MTM

[wan] 19/2/2021 07:34

I note Source Bioscience news this morning -

SourceBio International PLC COVID-19 mobile testing labs management contract
19/02/2021 7:00am
UK Regulatory (RNS & others)

19 February 2021

SourceBio International plc

("SourceBio", the "Company" or the "Group")

COVID-19 mobile testing labs management contract

SourceBio to support roll-out of mobile units containing Oxford Nanopore's LamPORE test

Mobile labs to meet demand for decentralised community testing as part of the pandemic response

SourceBio International plc (AIM: SBI), the international provider of integrated state-of-the-art laboratory services and products , announces that it has entered into an agreement with Mitie Security Limited ("Mitie") to manage the delivery of community based COVID-19 testing services through mobile testing units.

SourceBio will manage the delivery of the mobile COVID-19 testing laboratory service currently being deployed in a Department of Health and Social Care ("DHSC") pilot scheme . SourceBio will oversee all laboratory operations and processes and will have responsibility for all clinical governance, quality assurance, staff training, sample processing and information management.

Currently four mobile testing laboratories using Oxford Nanopore's LamPORE tests for COVID-19 have been deployed in the pilot which has been launched to support the Governments community-based testing efforts and ensure that COVID-19 testing is available for surge or increased infectious status within a specified region.

SourceBio will manage the mobile testing service on behalf of Mitie for the remainder of the pilot and is working towards continued involvement in a potential UK-wide programme.

Larger mobile testing units can process in excess of 1,500 samples a day, with 1,000 tests a day targeted for smaller vehicles. Patient swab samples are processed onboard with results provided within 24 hours. Oxford Nanopore's LamPORE test has been shown to be highly accurate for the detection of SARS-CoV-2. A study carried out by teams across the UK on over 23,000 samples have demonstrated gold-standard accuracy of the LamPORE test, showing >99.5% sensitivity and specificity, making LamPORE highly effect for testing symptomatic and asymptomatic individuals.

SourceBio has worked closely with the DHSC providing COVID-19 antigen RT-PCR testing services using the Company's laboratory facility. SourceBio has processed approaching 1,000,000 COVID-19 antigen RT-PCR tests for the DHSC and the NHS, Private Hospital Groups and Commercial customers since first offering its service in May 2020.

Jay LeCoque, Executive Chairman, commented: "We are very proud to support the UK's national testing effort to bring gold standard testing to the local communities as part of the effort to get the nation back to work. The need for localised testing and monitoring of infections is critical as the vaccine program accelerates. This project also highlights our continued work with the DHSC on multiple fronts as they work to manage the pandemic as it evolves."


LamPORE uses swab samples in the same way as a traditional PCR tests, which requires the sample to be collected in a transport media. And we already know that Source Bio uses PrimeStore MTM.

Research and analysis
Rapid evaluation of Oxford Nanopore Technologies’ LamPORE assay
Published 28 January 2021

[tongosti] 18/2/2021 18:04

Not getting any traction are we folks? Lol.

[mirandaj] 18/2/2021 09:43

Agreed wan and I do keep an eye on the various companies that they have supply agreements with as you can see. Thank you.

Miranda

[wan] 18/2/2021 09:18

Marianda...Demand for testing remains very high, so PrimeStore MTM volumes are likely to reflect that for most of 2021 (no doubt also aided by surge testing due to mutations). It will also be interesting to see what happens in terms of volumes, when EUA's for other sample collection devices are withdrawn, which is why I think PrimeStore MTM (and possibly other Longhorn products), will become a solid part of EKF's core business.

What you can tell from my last couple of posts, is that PCR surveillance testing and sequencing, which requires high quality stable specimen collection, along with global diagnostics manufacturing capacity increases and preparedness etc, will be felt way beyond COVID-19. Diagnostics, as a consequence of COVID-19, has taken centre stage!

Patience will be rewarded, as perhaps exemplified by EKF stating that it expects to implement a progressive dividend policy.

[mirandaj] 18/2/2021 09:13

As the share price of MyHealthChecked continues to increase I wonder how many collection devices have been ordered since initial supply.

From December 2nd 2020

The MyHealthChecked™ COVID-19 testing service will use the Clarigene® SARS-CoV-2 test supplied by Yourgene Health plc (AIM: YGEN) and the PrimeStore® MTM sample collection device supplied by EKF Diagnostic Holdings plc (AIM: EKF). The MyHealthChecked™ testing service allows samples to be quickly and conveniently taken at home using simple nasal collection swabs which are then sent via free postage for processing using established laboratory-based DNA and RNA detection methods.

In addition, initial purchase orders (of £16,500) have been placed with EKF Diagnostic Holdings plc ("EKF") for PrimeStore® MTM sample collection devices. Adam Reynolds is also a Director of EKF and this order has been treated as a related party transaction. Product pricing for the agreement has been prepared on an arm's-length basis and there is no minimum volume requirement. Having consulted with SPARK Advisory Partners Limited, the Independent Directors (those directors other than Mr Reynolds) consider that the terms of the order are fair and reasonable insofar as Shareholders are concerned.



Recent Trading update:

[mirandaj] 18/2/2021 08:45

Randox increasing tests:



Might there be any information on the volume for EKF Diagnostics?

[wan] 18/2/2021 08:25

An interesting promotion and rationale for combining EKF tests -

COVID19 and Infectious Mononucleosis present similar symptoms including fever, sore throat and muscle ache and comorbidities. It is important for physicians to identify the correct infection as treatment pathways are very different



One could imagine increased demand for EKF's CLIA waived RELY® Mono Rapid lateral flow test with 98% Sensitivity and 99% Specificity -

Rely® Mono Rapid Test provides a simple, fast and cost-effective test for Infectious Mononucleosis – sometimes referred to as Mono or glandular fever. Early detection of Infectious Mononucleosis helps reduce the risk of infecting others, minimizes the use of unnecessary antibiotics and improves patient care.

Symptoms of Infectious Mononucleosis include fever, sore throat and swollen lymph glands and mimic other serious infections that need different and urgent treatment.

SARS-CoV2 (COVID-19) is one virus that presents similar symptoms, such as fever and muscle ache and comorbidities (loss of taste and fatigue). It is important for physicians to identify the correct infection as treatment pathways for COVID-19 can be very different from those for Mono.

Rely® Mono Rapid Test qualitatively detects the presence of mononucleosis in whole blood, serum or plasma specimens.

By coupling lateral flow technology to the serological test for Mono, Rely® Mono Rapid Test provides a convenient two-step point-of-care diagnostic test for the virus.

[wan] 18/2/2021 07:30

Biden Administration Will Provide $1.6B to Improve COVID-19 Testing and Sequencing
Feb 17, 2021

NEW YORK – The White House COVID-19 Response Team announced on Wednesday that the Biden administration will provide $1.6 billion to expand and improve COVID-19 testing and genomic sequencing.

The US Department of Health and Human Services and the US Department of Defense will spend $650 million to expand testing opportunities for schools kindergarten through eighth grade and underserved settings like homeless shelters.

The agency will also establish regional coordinating centers to identify laboratory testing capacity and match it to specific areas of need. The coordinating centers will partner with labs, including academic and commercial labs, to collect specimens, perform tests, and report results. Carole Johnson, the response team's supply coordinator, noted during a media briefing that testing can be difficult to implement in non-medical settings, so the coordinating centers will help bridge that gap.

HHS and DoD will also invest $815 million to build and surge domestic manufacturing of testing supplies, such as pipette tips, injected molded plastics to contain testing reagents, and nitrocellulose for point-of-care antigen tests.

The US Centers for Disease Control and Prevention, meanwhile, will invest almost $200 million to expand genomic sequencing for the virus and detect emerging variants. The money will increase sequencing threefold from 7,000 samples per week to about 25,000 per week, the White House said. With the increase, the CDC will be able to identify SARS-CoV-2 variants sooner, Johnson said. CDC Director Rochelle Walensky said the agency is scaling up sequencing every day and that reaching the 25,000-sample mark will not happen immediately.

Walensky said the agency is partnering with states, commercial laboratories, and academia to increase both the volume and geographic diversity of samples for sequencing. In addition to more samples, Walensky said the agency also needs the computational and analytic capacity to understand the information coming in.

Johnson added that the money will provide significant help in the short term but that it was "far from what's necessary" and will be a bridge until Congress passes President Biden's $1.9 trillion American Rescue Plan. Jeff Zients, the team's response coordinator, said scaling up testing via passage of the American Rescue Plan would double testing capacity and drive down cost per test.

The American Rescue Plan includes $50 billion to expand testing by providing funding to purchase rapid tests, expand laboratory capacity, and support schools and local governments in implementing regular testing. An additional $30 billion would be invested in the Disaster Relief Fund to provide supplies such as glass vials and testing reagents, and another $10 billion would be used to increase domestic manufacturing for pandemic supplies.

Upon entering office, Biden announced his National Strategy for the COVID-19 Response and Pandemic Preparedness, which said the federal government intended to expand the rapid testing supply, double test supplies, and increase testing capacity, along with increasing antigen and molecular testing manufacturing in the US, filling supply shortfalls, and expanding surveillance for virus hotspots and variants. The plan also created a national pandemic testing board to oversee the implementation of testing.

Full story -

[boadicea] 17/2/2021 20:18

I think we can probably all agree that the position of AIM not being recognised by HMRC as being a stock exchange seems to be something of an anomaly. The wording of the announcement would have been less questionable if the word 'another' had been replaced by 'any'.

[melody9999] 16/2/2021 23:40

wan 1499 - thanks for that

[wan] 16/2/2021 18:04

Well, if it's a sub-market of a recognised stock exchange, then indirectly it must be recognised, but irrespective of whether AIM is a recognised stock exchange or not, does the announcement actually imply that AIM is a recognised Stock exchange? Not in my reading, as the brackets are used to separate off information that's not essential to the meaning of the rest of the sentence -

365 days following admission to trading on AIM (or another recognised stock exchange) of the issued share capital of Trellus; or
if the issued share capital of Trellus is not admitted to trading on AIM (or another recognised stock exchange) within two years of the date that the Dividend is settled, two years from the date that the Dividend is settled (the “Lock-up Period”).
(END)

So, it is stating specifically admission to AIM, and the brackets are being used for information that is not part of the main content i.e. or perhaps another stock exchange that recognised as being such.

Personally, I am not going to lose one iota of sleep over it (I don't get much anyway!) you will note the use of brackets ;-)

[sharw] 16/2/2021 17:06

No, it is not just the Exchange but the market as well that is or is not recognised (by HMRC). So the main market is recognised but AIM isn't - otherwise you would pay stamp duty on purchases there. This is where the announcement is wrong - it implies AIM is an exchange but it is not - it is a market of an exchange. So LSE is recognised and the main market is listed as such but not AIM:

[wan] 16/2/2021 11:50

Boadicea...My understanding is that AIM is a sub-market of the London Stock Exchange and it's therefore very much a recognised stock exchange -

London Stock Exchange's market for small and medium size growth companies


London Stock Exchange offers a choice of markets for listing equity
Our Main Market is one of the world's most international and diverse capital markets. There are three different segments of the Main Market: Premium, Standard and High Growth Segment, each tailored to different capital raising requirements.

AIM is a platform for small and medium size growth companies in need of access to capital to realise their growth and innovation potential. Growing companies from around the world and at different stages of development can join AIM.

Use the comparison table below to see what route to market is best for your company.

[boadicea] 16/2/2021 11:36

Thanks pldazzle and wan for your comments.
My original question was meant to read "How is the TAX to be paid if they [the dividend shares] cannot be liquidated? However the answer covers the point.

I am also intrigued by another technicality (perhaps I'm being a bit nerdy!) The announcement refers to "AIM or ANOTHER RECOGNISED stock exchange"... but I thought AIM was specifically NOT a 'recognised' stock exchange!