Ekf Diagnostics Share Discussion Threads

[hastings] 05/9/2020 13:09

I should be speaking with them again on results day, so will add another write up for interest.

[wan] 05/9/2020 12:59

Epicsurf....EKF stated in their last Trading Statement that they expect to announce the unaudited results for the six months ended 30 June 2020 in the first half of September 2020, with the date to be confirmed in a subsequent announcement.

So yes, not long to wait, albeit they have guided on the financials. Hence, most investors will be particularly interested in the commentary, and not least the outlook.

[epicsurf] 05/9/2020 10:40

Cheers wan, are we expecting half year report and outlook in the next couple of weeks?

[wan] 05/9/2020 10:11

I note that yesterday Roche obtained EUA for a an automated multiplexed real-time RT-PCR assay intended for simultaneous qualitative detection and differentiation of SARSCoV-2, influenza A virus, and/or influenza B virus RNA in healthcare provider-collected nasal and nasopharyngeal swab specimens and self-collected nasal swab specimens.

Roche COVID-19, flu combo test gets FDA emergency authorization

PUBLISHED
Sept. 4, 2020


PrimeStore MTM already allows labs to differentiate between flu and COVID-19 by enabling the process of multiple tests from a single sample that has been inactivated and stabilised in PrimeStore MTM.

Laboratories have independently validated PrimeStore MTM with a range of platforms such as Roche, Thermo Fisher, Abbott, Siemens, Luminex, Bio-Rad, PSS, Promega, and BioMerieux, as well as the Cepheid GeneXpert point of care platform -


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


Roche have several PCR platforms, and despite specific information not being available anywhere on Longhorns or EKF's website, I can confirm 100% that PrimeStore MTM is indeed compatible with the Roche Cobas high-throughput platform.

[cambridgedon] 03/9/2020 16:49

Wan,
Thanks! You are a font of knowledge.
CD

[wan] 03/9/2020 16:27

Cambridgedon...Currently EKF do not offer a test for COVID-19. What I would say though, is that a number of the tests that are being trialled/developed require an inactivated sample where the DNA and RNA is stabilized and preserved.

PrimeStore MTM could make it possible to 'safely' bring a simple lab (mobile?) nearer to the test setting.

As a reminder -

Once a swab or biofluid is added to PrimeStore MTM the user has a ‘snapshot’ in time for that inactivated microbial sample. The microbe’s DNA, and more importantly the labile RNA, is immediately stabilized and preserved at the point of sampling. So, samples in MTM do not have to be pre-processed in BLS-III or even BLS-II safety levels, just safe normal laboratory practices for testing are required.


(Also see my previous posts 401 and 438)

[cambridgedon] 03/9/2020 09:11

Is EKF capable of delivering these rapid tests?
CD

[wan] 03/9/2020 08:28

Apparently, current demand for pcr testing is (once again) outstripping the already increased testing capacity, and we are not even in flu season yet!

Full government release regarding the £500m investment in expanding trials and investment in new testing technology and increased testing capacity -

Press release
£500 million funding for quick result COVID-19 test trials
A new £500 million funding package will be invested in next generation testing technology and increased testing capacity.

Published 3 September 2020
From:
Department of Health and Social Care

[wan] 01/9/2020 07:52

Just to add to my comment in post 459 regarding the ultimate reality and that antigen testing is unlikely to provide a panacea in terms of COVID-19 testing -

31st August 2020
Is Abbott Antigen Test Answer to US COVID-19 Testing Problems?
Stakeholders Emphasize Caution

Some lab experts say that Abbott's test is open to multiple variables, which could lead to improper use and incorrect test results.


And probably the reason that a confirmatory PCR test will also be required with certain antigen test results.

[wan] 31/8/2020 09:09

Setting aside, for the time being, EKF's net cash of circa £16m and the Renalytix holding worth circa £15m, and looking beyond PrimeStore MTM. EKF has wide exposure to another global epidemic. This other epidemic, in an unconventional sense, is the diabetes epidemic. Diabetes is not an infectious disease, but its high prevalence is global in nature. And in a conventional epidemic sense, Nearly 500 million adults worldwide have diabetes and its relationship with COVID-19 is now a major concern and an area of medical attention and focus.

EKF's diabetes care range covers all aspects of diabetes care, research, diabetes clinics, emergency rooms, GP surgeries, sports clinics and hospital labs.

Looking beyond diabetes, PrimeStore MTM and beyond EKF's financial metrics, how does one value the agreement and relationship with Mount Sinai? 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.

This has already resulted in shareholders benefiting from owning shares via a dividend in specie in the spin off, Renalytix, and if you held onto your in specie shares they are currently valued in excess of £5 per share. Plus, Renalytix has continued the close working relationship, with Mount Sinai Health System and Renalytix AI announcing the formation of Kantaro Biosciences, a Mount Sinai venture, to develop and scale production and distribution of a test kit based on the Mount Sinai-developed high-performance serologic assay for SARS-CoV-2 antibodies. Kantaro has partnered with Minneapolis-based Bio-Techne Corporation to develop and launch the new kit, with the goal of producing more than ten million patient tests per month. Furthermore, Renalytix have approved the distribution of in-specie shares in the spinoff Verici Dx Limited.

Aside from what other opportunities may emerge from the EKF/Mount Sinai relationship, which will be difficult to assess, apart from understanding it offers unspecified significant innovative commercial opportunities, we now have another tangible opportunity from the relationship in the form of Trellus Health. But how might we assess the potential of Trellus Health, a digital health solution for complex chronic conditions and who's 'initial' focus is IBD, but with the 'platform' perhaps being capable of much more? -

Clearly the track record and read-across to the pent-up demand for the Renalytix offering is very encouraging, but to add some food for thought in terms of the potential, the following is very encouraging -

25th August 2020
Lyra Health hits $1.1B valuation, plans teletherapy expansion
Mental health startup Lyra Health raised a $110 million series D, valuing the company at $1.1 billion. The company plans to use the funds to expand its teletherapy service and develop additional mental health solutions.


5th August 2020
The deal was “inevitable” and other takeaways from the massive $18.5B Livongo-Teladoc merger
The two fast-growing digital health companies struck a merger agreement on Wednesday. Teladoc will acquire Livongo in a deal that would value the startup at a whopping $18.5 billion.

In one of the biggest ever digital health deals in history, Teladoc announced Wednesday it would acquire Livongo, valuing the company at $18.5 billion. Both have experienced growth likely beyond their wildest dreams in light of the Covid-19 pandemic, as patients and providers have rushed to adopt digital health, and as regulators have removed barriers to such adoption.

Full story -


Further encouraging reading -

24th August 2020
3 technologies that will play a pivotal role in the pandemic and beyond
Though the rest of 2020 is still unknown, one fact is very clear: Clinicians will need to continue to lean heavily on technology like RPM, AI and telehealth to ensure successful patient outcomes across the board.
By ROBIN CAVANAUGH

Full story -


Published July 7th 2020
By Susan Kelly
Dive Insight:
Investment in the digital health sector was off to a strong start in 2020 at a record $3 billion in the first quarter alone, before momentum stalled in March and April. The halt in activity as COVID-19 spread quickly around the globe, however, did not last long. Rock Health notes that of 11 large deals valued at $100 million or more in the first half, five occurred in May and June, when the outbreak and resulting U.S. economic downturn were well underway.

Funding for digital health companies in the second quarter was $2.4 billion, 33% above the $1.8 billion quarterly average for the prior three years. The average size of a deal in the first half of 2020 was $25.1 million, easily topping the previous record of $21.5 million in 2018.

The most popular areas for investment included on-demand healthcare services, disease monitoring and behavioral health.

Full story -

Published 26th August 2020
By Susan Kelly

Dive Brief:
A push to develop standards and identify best practices to guide rapid growth in the emerging field of digital therapeutics has attracted the support of 25 tech companies, ranging from Google Health and HP to Livongo, Philips and ResMed.
The companies have joined an initiative led by the Consumer Technology Association to define performance requirements for digital therapeutics, described by the group as a newer branch of digital health that incorporates software applications into medical treatment.
The effort comes as FDA moved to lower regulatory barriers during the public health emergency for digital therapeutic devices designed for use in treating psychiatric disorders.
Full story -

[wan] 30/8/2020 18:20

Plus, it's not all about PrimeStore MTM.

In this regard, more from me later.

[wan] 30/8/2020 18:15

Previously I have provided food for thought, along with the scientific evidence and links, providing good evidence that PrimeStore MTM could enhance, possibly enable, certain RT-LAMP saliva tests. Implying - in the future - that use of PrimeStore MTM for COVID-19 testing could significantly increase via use across a wider spectrum of global testing.

[wan] 30/8/2020 17:55

Pugugly...I had actually seen that, and I repeat from my post. Specificity, sensitivity, and the better positive and negative predictive values will be key differentiating factors, along with the ability and utility to 'accurately' differentiate between influenza and coronavirus, which will likely be an increasingly important factor.

I note in this regard, there is no mention of differentiating between flu and coronavirus, the test is still in development and has not been validated.

[wan] 30/8/2020 16:59

The likely reason for a pullback in EKF shares on Thursday and Friday last week was connection to the news of EUA in the US for Abbott's antigen test, with the ramp up of manufacturing and a large government contract (and putting aside political influence and commentary etc) implying that antigen testing will take a notable share at the expense of molecular testing (which I don't think paints the whole picture or indeed is reflective of the ultimate reality) -

As Abbott Stock Rises on EUA for Antigen Test, Competitors' Shares Take a Hit
Aug 27, 2020


Abbott gets $760M contract from HHS to deliver 150M antigen tests



An aspect that I have highlighted numerous times is that PrimeStore MTM is not dependant on the success of a particular molecular (PCR) test. The other important point is that PCR testing remains the gold standard, in which governments and companies have made significant investments to support capacity increases and improve turnaround times (check my previous post 447 regarding the significant investment by Public Health Wales). In another example/development, VW is installing facilities for voluntary COVID-19 tests at sites across Germany, stepping up efforts to protect its large industrial operations as infection rates rise across Europe.

The automaker will be able to handle as many as 2,400 tests per day in Wolfsburg, the home of its headquarters and largest factory. Results will be available within 24 hours. Full story -

August 26, 2020 05:32 AM
VW offers coronavirus testing amid rise in German infections
Bloomberg


Cost per test will obviously be an important factor, but clearly it's not the only consideration, as witnessed by the investments by Public Health Wales and VW!

Overall, it's good news that we have an array of rapid tests being authorised, with more in submission/development and yet to be authorised. And without meaning to be critical of Abbott's new test which will obviously have its place (and help reduce some of the bottlenecks on molecular testing), antigen testing is not as accurate and reliable as molecular testing. This is perhaps best highlighted by the FDA authorisation details -

Authorized Product Details
Your product is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasal swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. The SARS-CoV-2 nucleocapsid protein antigen is generally detectable in nasal swabs during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and presence of clinical signs and symptoms consistent with COVID-19.


Not to mention that a molecular PCR test will be required for confirmation regarding certain results from antigen testing.

With the flu season nearly upon us it will also be important to differentiate between influenza and COVID-19, which the antigen test cannot do. However, several molecular (PCR) combination tests are believed to be in the final stages of development and/or submitted for authorisation and they will be able to identify different pathogens in the sample, with apparently a turnaround time of under 2 hours. So, antigen testing is unlikely to provide a panacea in terms of testing, and thus unlikely to prevent PCR testing retaining the top spot and preference in terms of specificity, sensitivity, and the better positive and negative predictive values.

It will also be interesting to see what RT-LAMP testing offers as more are authorised, which will apparently be faster and cheaper than many current PCR tests. RT-LAMP testing is potentially compatible, if not preferable in some cases, with sample collection via PrimeStore (amongst other attributes, reducing the necessary steps and reagents). And even without being a combo COVID-19/Influenza test, RT-LAMP assays could still provide relatively rapid differentiation between flu and coronavirus by utilising different (multiple) tests from a single sample, which PrimeStore MTM enables as it provides safe collection, transportation and handling of pathogenic samples including Covid-19 and Influenza -

Combined COVID-19 and flu testing
It’s clear that a strong testing programme is needed ready for flu season and a potential second wave of COVID-19 – as thousands of people are going to start presenting with symptoms that could be flu or coronavirus.

As multiple infectious disease tests can be processed from one sample swab, this makes PrimeStore MTM ideal for the approaching flu season. This is because samples collected and stored in MTM can be tested for both COVID-19 and influenza from a single swab sample that has been inactivated and stabilised. This, in addition to the fact that refrigerated transport and storage is not required, can assist with disease differentiation at reduced costs when compared to standard collection kits.



In short, there will be a relatively wide range of available tests, and my best guess is that a combination of PCR and RT-LAMP assays, utilising different sample types (saliva and nasal), are likely to take the largest share of global testing. Time will tell!

[wan] 28/8/2020 05:33

An interesting and timely development with EKF providing the whole collection kit for COVID-19 and influenza testing, which is in addition to the current tube and reagent offering and comes in two forms, a sample collection kit for on-site mass sampling and a postal sample collection kit, -

NEW PrimeStore MTM Sample Collection Kit - Convenient collection kits designed for home use and mass on-site sampling


Edit - Which actually aligns with the recent announcement that states it was for the supply of "sample collection kits"

[cravencottage] 27/8/2020 17:34

I note 2 million shares traded at 57.5p

An institution balancing the books?

[tole] 27/8/2020 13:51

Quick dip which closed the small gap at 52p

[retirementfund] 26/8/2020 09:17

I am intrigued to see where others have this post results. Personally I would be surprised if it does not pass 70p

[wan] 25/8/2020 08:25

I note from yesterday that larger trades are still featuring.

Most readers will be familiar with the attributes of PrimeStore MTM that EKF are highlighting and promoting, not least the following -

Combined COVID-19 and flu testing
It’s clear that a strong testing programme is needed ready for flu season and a potential second wave of COVID-19 – as thousands of people are going to start presenting with symptoms that could be flu or coronavirus.

As multiple infectious disease tests can be processed from one sample swab, this makes PrimeStore MTM ideal for the approaching flu season. This is because samples collected and stored in MTM can be tested for both COVID-19 and influenza from a single swab sample that has been inactivated and stabilised. This, in addition to the fact that refrigerated transport and storage is not required, can assist with disease differentiation at reduced costs when compared to standard collection kits.


The following article provides for a very informative read and brings into sharp relief the advantages provided by PrimeStore, and where one can start to see the enduring effects from the the current pandemic, as we thus enter a new era of testing and testing capabilities, a new era where diagnostics will play an increasingly important part in the response and global preparedness (selected excerpts follow)-

Op-Ed: What We've Learned From COVID-19 Testing
— One lesson: be prepared
by Justin J. Bellante, MS August 22, 2020

Health experts warn that a second wave or extended first wave compounded with the cold and flu season may overwhelm our healthcare system as providers scramble to distinguish between who has COVID-19 and who has the flu or simply a cold.

Mind you that the healthcare system is now further diminished due to furloughs and cost-saving measures as elective procedure utilization has plummeted.

In the absence of a vaccine, we're starting to realize that we're going to have to live with COVID-19 for awhile. So, what have we learned? Has our spring and summer of COVID-19 taught us anything to help us through the rest of 2020?

First, we've learned that testing is critical, and we were woefully unprepared for the first go-round. As testing capacity improved, our distribution system failed to get sample collection supplies to many labs.

We learned that laboratory testing capacity really isn't the challenge. Disease surveillance is the challenge. Getting testing to the people and communities who need it, when they need it, in a place they can access it, is the challenge.

Building and operating a delivery model to administer and process tests is essential. Similar to the shipment of ventilators from one hotspot to another, we need a national testing system that effectively and efficiently collects samples and then delivers them to labs nationwide.

This model must move beyond merely collecting samples at hospitals, clinics, and doctor's offices, and should also include at-home, consumer-administered testing. And the testing must move beyond the centralized laboratory oligopoly that drives results wait-times to 7-14 days as cases spike, and must leverage distributed networks across the country so capacity can be efficiently optimized and the many independent labs who have stepped up with testing solutions can have their day in the sun.

We also need a diverse supply chain with a variety of sample collection devices and testing models to guard against the supply-chain breakdowns that sunk us in the spring. If we run out of flocked swabs and viral transport media, shame on us.

One ray of hope, the authorization of saliva collection, has opened up the consumer genetic testing supply chain to add capacity.

We need better and different tests to know what virus is really impacting someone. Testing in the spring ruled out COVID-19 in about 90% of cases. That kind of knowledge is just a first step as we move into cold and flu season.

Use of combined tests that can distinguish between COVID, the flu, and the common cold -- along with the aforementioned diagnostic network that gets samples tested quickly -- will be imperative.

Full story -

[melody9999] 24/8/2020 23:55

Great BB (thanks) and great company. Starting to get noticed I suspect and for good reason. My largest holding.

[pldazzle] 24/8/2020 16:47

wan (#449) - Very many thanks.

[brucie5] 24/8/2020 16:10

Just added to make a principal holding. Really excellent coverage here, and notably of course, by Wan.

[rivaldo] 24/8/2020 13:32

Nice to see 59p being paid by buyers now.