Ekf Diagnostics Share Discussion Threads

[wan] 28/9/2019 07:13

26th September 2019

EKF Diagnostics, the global in vitro diagnostics company, announces that it has opened a new Research & Development facility at its Cardiff, UK headquarters. The new Special Projects Laboratory will focus on developing new applications for EKF’s many point-of-care and central laboratory medical products to enable the Company to enter new market sectors, as well as providing additional diagnostics sales and regulatory support.

EKF’s Cardiff-based laboratory complements and supports EKF’s other global R&D facilities by focusing on product application development and some aspects of data support. The two new research scientists based there will also investigate how EKF products can bring benefits to new markets beyond healthcare and diagnostics, such as the veterinary, food and brewing industries.

In addition, the new laboratory will provide diagnostics sales support through product comparisons and new technology evaluations. Its regulatory support work will include data generation for new territory registrations across the world, as well as claim support for existing products where more data may be required. The lab will also help EKF’s other R&D teams during product development by aiding with bench work and sample testing that can otherwise slow down product launches. For example, the lab will be key in implementing suggestions from the FDA regarding a new product registration in the USA.

“Our new Cardiff-based lab is already assisting our other R&D teams globally, freeing them up to dedicate their time to EKF’s new product development and realisation pipeline,” said Dr Gary Dowthwaite, Special Projects Coordinator, EKF Diagnostics. “For example, they are working on a project to obtain data from animal species using our new Lactate Scout 4 analyser. This will enable EKF to enter the veterinary testing market, as raised lactate levels are indicative of an underlying health condition in small animals.”

Full story -

[wan] 21/9/2019 11:45

Pugugly...Fair enough and glad to hear that EKF is a long term holding, a strategy that I believe will pay dividends ;-)

[pugugly] 21/9/2019 11:35

wan fyi - Partially news flow driven - Been holding EKF since April/June 2015 and with Renalytx spin-out in Long term portfolio -

[wan] 21/9/2019 08:25

Pugugly...Thanks, but I note your interest in any stock appears to be only fleeting (on good and bad news). I appreciate everyone has their own investing/trading style though, and it takes all sorts to make a market etc.

[pugugly] 20/9/2019 22:38

Daily Mail - Might but a bit of oomph behind the share price on Monday
"PUNT OF THE WEEK: Medical specialist EKF Diagnostics in good health as it signs US deal"

[wan] 15/9/2019 07:42

A few tweaks to the title post, and the inclusion of a link to Mount Sinai Innovation Partners, which is worth a visit.

[wan] 10/9/2019 08:40

China, which is the most populous country, also ranks number one in terms of diabetic population, with an estimate of 109.6 million adults with diabetes. Over the past three decades, the prevalence of diabetes in China has sharply increased. And given the essential role of HbA1c in the diagnosis and management of diabetes, the following puts the potential for Quo-Lab in China into perspective -


2018
Perspectives in Diabetes

Diabetes in China: Epidemiology and Genetic Risk Factors and Their Clinical Utility in Personalized Medication

Epidemiological Trends of Diabetes in China

Abstract
The incidence of type 2 diabetes (T2D) has rapidly increased over recent decades, and T2D has become a leading public health challenge in China. Compared with European descents, Chinese patients with T2D are diagnosed at a relatively young age and low BMI. A better understanding of the factors contributing to the diabetes epidemic is crucial for determining future prevention and intervention programs. In addition to environmental factors, genetic factors contribute substantially to the development of T2D. To date, more than 100 susceptibility loci for T2D have been identified. Individually, most T2D genetic variants have a small effect size (10–20% increased risk for T2D per risk allele); however, a genetic risk score that combines multiple T2D loci could be used to predict the risk of T2D and to identify individuals who are at a high risk. Furthermore, individualized antidiabetes treatment should be a top priority to prevent complications and mortality. In this article, we review the epidemiological trends and recent progress in the understanding of T2D genetic etiology and further discuss personalized medicine involved in the treatment of T2D.

Summary
T2D can no longer be considered a disease of affluent nations because more than 60% of the world’s population with diabetes comes from developing countries. China is a major epicenter in the diabetes epidemic. The increase in the prevalence of T2D is linked to changes in lifestyle, the increased prevalence of obesity, and genetic factors. Despite great advances in genetic studies, the clinical utility of genetic information in the prediction, early identification, and prevention of T2D remains in its preliminary stage. Pharmacogenomics is an emerging field that explores the role of inherited and acquired genetic variants in drug response and efficacy and thus can make contributions to antidiabetes drug selection. As the loci identified thus far explain only a small amount of the estimated heritability of T2D, intensive studies should be conducted to further identify T2D causal variants, epigenetic modifications, gene–gene interactions, and gene–environment interactions and to translate novel findings to clinical applications.

Full Report, American Diabetes Association -

[wan] 10/9/2019 07:47

Where to start without using overcharged superlatives!

A truly excellent set of Half-Year Results, along with exciting additional news, both separately and indeed 'within' the Results commentary e.g. -

"Our local partner has been successful in achieving regulatory approval for Quo-Lab in China. The pre-market processes required to open this market are also now complete."

In my view, the potential market for Quo-Lab in China is very large indeed!

[wan] 14/8/2019 08:00

EKF's hemoglobin product range currently provides the largest share in terms of revenues and the number of users (FY 2018 £13.7m)

In 2018 EKF sold more than 25 million tests for the DiaSpect Tm range, and 22 million tests for Hemo Control and HemoPoint® H2.

The following may imply that hemoglobin testing may have new uses/monitoring -

High hemoglobin levels, anemia linked to dementia, Alzheimer’s risk

Wolters FJ, et al. Neurology. 2019

August 5, 2019

In the general population, both high and low levels of hemoglobin were linked to a greater long-term risk for dementia, including Alzheimer’s disease, data published in Neurology showed.

In addition, the researchers found that anemia was associated with a 34% increased risk for dementia and a 41% increased risk for Alzheimer’s disease.

"With around 10% of people over age 65 having anemia in the Americas and Europe and up to 45% in African and southeast Asian countries, these results could have important implications for the burden of dementia, especially as the prevalence of dementia is expected to increase threefold over the next decades, with the largest increases predicted in the countries where the anemia rate is the highest," M. Arfan Ikram, PhD, of Erasmus Medical Center in the Netherlands, said in a press release.

Full story -

[wan] 21/7/2019 11:38

I hope readers approve of this new EKF thread, title and introduction, which I may tweak (I already have!)

[wan] 21/7/2019 11:30

I hope all readers will approve, but given that EKF has evolved and has also initiated a dividend, I have started a new and hopefully more appropriate/accurate thread -

[wan] 21/7/2019 11:21

The initiation of a dividend would imply that EKF are seeing a strong trend in terms of profitable growth and cash generation. And it could therefore represent a signal that EKF are entering a new phase in terms of profitable growth and hopefully share price performance.

Whilst the dividend payment is subject to shareholder approval in H1 2020, the dividend yield potential (based on today's share price) is quite reasonable at circa 3% and obviously potentially greater if this proves to be an interim dividend! Importantly, the dividend is not coming at the expense for the potential of further growth.

The healthy cash and marketable securities position of £15m at the half-year (giving cash and marketable securities at current market value of over £20m) would imply that the dividend payout at circa £4.5m is likely to represent a relatively low payout ratio, meaning a healthy percentage of earnings will be retained for investing and growing the business.

If realised and sustained, a combination of growth, share buybacks and dividends would certainly provide for healthy and reassuring combination!

EKF's revenues are generated from the point of care (POC), central laboratory and life science divisions, with the largest contribution currently coming from POC.

EKF have a large installed base of POC instruments which is growing and generates reliable recurring revenues. This impressive installed base of instruments is set for improved growth and provides for stable and predictable revenues, which adds good support to providing an on-going dividend policy.

The Central Laboratory provides steady and reliable revenues, and with the significant investment and upgrade to the life Science enzyme facility enabling the Oragenics, Inc contract and also providing increased capacity to accommodate additional contracts, this division should start showing very good rates of growth.

An investment in EKF provides good exposure to the central laboratory/life science and POC markets. The POC market is offering a combination of growth due to wider adoption, technological advancements and favourable demographic factors, as well as providing reliable revenues and relatively high barriers to entry, and thus offers defensive qualities as POC products associated with the effective diagnosis and management of medical conditions and disease are becoming evermore essential tools. The Central Laboratory division is providing an equally reliable income stream, but due to recent investments and expansion, this division has entered a new phase that has already started delivering good rates of growth.

EKF have announced that it has entered into a non-exclusive Preferred Partner Arrangement (the “Agreement”) with Mount Sinai Innovation Partners (“MSIP”) -

In connection with the Agreement, the Company has signed a non-binding term sheet with Mount Sinai, which will allow the Company to explore the opportunity to support the licensing of technology originating from Mount Sinai to establish a novel digital health platform for earlier intervention in and better management of patients with Inflammatory Bowel Disease (“IBD”).

EKF website -


EKF's 2021 – 2024 Growth Strategy -


Please conduct your own research when making investment decisions, as the originator, or the threads contributors, could be either wrong or inaccurate.

[andrewbaker] 16/7/2019 11:29

As I said in blog 1322 in January, something is happening, and it is to the upside. I've bought more this year, and am very happy :) It's trading well, plus a possible Chinese bid. And pharma, along with tech, are good areas to be in right now, IMHO.

[wan] 15/7/2019 09:15

With revenues expected to show continuing momentum over the balance of the year, cash generation looks set to be very healthy indeed.

The management have been very diligent and effective in the deploying the various growth initiatives, but being greedy, I would like to see some new contract wins to add even more wind to the sails of those growth initiatives ;-)

'One' such initiative was the significant upgrade of EKf's enzyme facility in the US, which has enabled EKF to broaden their offering in pharmaceutical enzymes. Subsequently EKF are in a position to attract other partners alongside that for Oragenics, Inc (which is a growth driver on its own).

[wan] 15/7/2019 07:28

Excellent Trading Statement with excellent cash generation, and as I hoped, EKF has become a dividend paying stock, fantastic news!

[bellymonster] 15/7/2019 07:19

Nice trading statement. Intention to pay a 1p dividend and shares in RENX valued at 3.25m now worth 8.75m.

[buywell3] 14/7/2019 08:06

A piece of test equipment that the world badly needs is to detect CJD, many forms exist eg vCJD,iCJD,fCJD, and sCJD (5 subtypes of that one alone), in human beings.

If EKF could do this , or RNS that they were going to do so, buywell would invest in the company Mr Mills

Here is why such a test instrument has thus far been IMO held back from coming into being in the USA.

Hundreds of thousands of CJD cases have been misdiagnosed in the USA as Alzheimer's
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The BBC2 programme , Mad Cow the new new wave las thursaday at 9pm, didn't dare pick up on this, because it was warned off.

But it means that 100% of surgical instruments should be tested for protein residue for EVERY type of operation not just neurology and eye surgery and a few others as detailed in DOH HTM 01-01 2016 update , here is why:

2003



'' Now people are beginning to realize that because something looks like sporadic CJD they can't necessarily conclude that it's not linked to (mad cow disease)," said Laura Manuelidis, section chief of surgery in the neuropathology department at Yale University, who conducted a 1989 study that found 13 percent of Alzheimer's patients actually had CJD.

Several studies, including the one by Manuelidis, have found autopsies reveal 3-percent-to-13-percent of patients diagnosed with Alzheimer's or dementia actually suffered from CJD. Those numbers might sound low, but there are 4-million Alzheimer's cases and hundreds of thousands of dementia cases in the United States. A small percentage of those cases could add up to 120,000 or more CJD victims going undetected and not included in official statistics.''





buywell notes

In 2003

From the Laura Manuelidis, section chief of surgery in the neuropathology department at Yale University findings in 2003:

At her lower end figure of 3% of misdiagnosed Alzheimer's cases which should have been diagnosed as CJD, this works out that there should be a minimum of 120,000 cases a year minimum of CJD being diagnosed.

In 2018

5.7 million Americans of all ages are now diagnosed as having Alzheimer’s and now someone in the United States is being diagnosed with Alzheimer’s disease every 65 seconds.


Based upon the average range of the studies which misdiagnosed Alzheimer's which should have been diagnosed as CJD ie 3% to 13% , average = 8%


The number of people in the USA today that should be diagnosed with a form of CJD is 8% of 5.7M = 456,000.

Yes 456,000 of CJD cases in the USA that have at present been wrongly diagnosed as Alzheimer's



WHY is this happening and why are CJD cases not been diagnosed correctly ?
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buywell thinks this is because:

1. No piece of test equipment exists that can test for any form of CJD ( at least
eight types now exist, more being identified) in a living human being.

2. CJD can at present only be 100% correctly identified by post-mortem


3. CJD is a prion disease always fatal and no cure ... like Alzheimer's. Hospital
staff know this and also that it is highly contagious and transmissible
disease, they are scared of catching it themselves and rightly so.



There is a development in the USA where some state universities are trying to develop a piece of test equipment that will detect CWD in a living deer. ( CWD is a TSE, like BSE, a prion disease in Cervids)

One has to ask why is the FDA and USA government not involved or at least funding this ?

buywell thinks because such a piece if new test equipment can then be modified to detect CJD in humans and then case numbers will rocket to the hundreds of thousands causing mass panic.

[wan] 14/7/2019 07:32

The following is interesting given EKF are working to adapt their existing lactate technology for use in clinical settings -

Point of Care: The Journal of Near-Patient Testing & Technology.
JUN 2019

Clinical Performance and Utility of Point-of-Care Lactate Technology in Patient Care Pathways

Lactate is a commonly evaluated analyte in acutely ill patients. It is used as a prognostic, diagnostic, and monitoring tool in a variety of clinical conditions including sepsis, trauma, infectious diseases, and perinatal conditions. Elevated lactate levels, above specific thresholds for each condition, are considered critical values necessitating intervention. In certain of these cases, a fast lactate result by point-of-care (POC) devices is crucial in assisting with the medical management of the underlying condition. It is becoming increasingly evident that POC technologies are part of the transformation that is being observed in health care. Rapid results of certain analytes at the point of care enable clinicians to make immediate treatment decisions without having to wait for results from centralized laboratories. Lactate, as a critical marker, is a perfect candidate for POC testing and has been utilized as such in a variety of clinical settings, including prehospital and emergency medical services, emergency departments, and intensive care units.

Full abstract -

What's perhaps even more interesting and given that EKF already targets the sepsis market, is that lactate and the device referred to in the above article is also targeted at rapid sepsis detection and monitoring -



Surviving Sepsis Campaign Hour-1 Bundle of Care Elements:

[wan] 09/7/2019 09:43

Recall that the initial launch of Diaspect in the US was February, but that the full launch appeared to be in early April (when it became available on Mckesson's website).

Obviously we do not know what the size of the stocking order was from Mckesson, but we do know that it's being sold as a kit with 100 tests.

I was interested to note that there now appears to be only two options for individually testing hemoglobin via Mckesson, one is obviously their branded Diaspect.

What I also found quite interesting was that the number above the products, which when you hover over it tells you, in the case of the Mckesson branded Diaspect, that over 302 providers like you recently used this product, and when you do that for the alternative product is shows the number of recent users as 10!

If we take the full launch as early April, then over 3 months that appears to be a very good start. I also note that if you do the same for the separately sold 100 microcuvette/tests and separate controls, that ordering/re-ordering of tests has also made a good start at 144 and 78 respectively.

To put that into at least some perspective, Mckesson still sell the microcuvette/tests for the Hemocue 201 instrument that they were previously selling, and if you do the same exercise you get 1,198. However, the Hemocue microcuvettes have been available for a number of years.

This appears to imply that market penetration is going quite well from a standing start in the US, where Diaspect had no previous sales.

[wan] 19/6/2019 10:52

Recall that back in July 2018 EKF announced a manufacturing partnership with Oragenics, Inc -

19 July 2018
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (MAR).

EKF Diagnostics Holdings plc
("EKF", the "Company")

Manufacturing partnership with Oragenics, Inc.

EKF Diagnostics Holdings plc (AIM: EKF), the AIM listed point-of-care business, announces that it has signed an exclusive agreement with Oragenics, Inc. (NYSE American: OGEN), a Florida-based biopharmaceutical company, for the manufacturing of Oragenics’ lantibiotic bulk drug substances in the United States.

Oragenics is developing a pipeline of novel therapeutics to address the rise in drug-resistant infectious diseases as well as oral mucositis. Under the collaboration agreement, EKF Diagnostics will manufacture compounds intended for preclinical and early stage clinical trials. Manufacturing will be completed at EKF’s Elkhart enzyme production facility in Indiana, USA.

It is estimated that the partnership should generate multi-million dollars in revenues to EKF Diagnostics over the duration of the manufacturing agreement
(END)

I note the various recent Oragenics news flow, amongst others the update regarding their phase 2 enrolment, all of which would appear to imply that the manufacturing and supply of the bulk substances has commenced (or is imminent) -

[wan] 10/6/2019 08:57

Good morning pldazzle...Let's put it this way, I don't disagree with you.

It's a complex area that EKF clearly put a lot of time and effort into, so I am reasonably satisfied that the outcome was indeed definitive.

Thanks for your input.

[pldazzle] 10/6/2019 07:28

Hi wan -

You say "Arguably the actual outcome has been different".

(1) I'm not at all sure that's the case; but, even if it was,
(2) I can't see that it became different only after the balance sheet date 31/12/18, far less after the date of the auditors' report. (Thus there would be nothing new for the purposes of the current year accounts.)

And -

(3) What difference does it make to EKF anyway? There would be tax effects for some EKF PI shareholders, but otherwise nothing other than a book entry. No change in net tangible assets: at best an increase in goodwill, which would be fairly meaningless and would certainly not add anything to EKF's value. The RENX shares are off the books, finito. Do you agree, or am I still missing something?