Ekf Diagnostics Share Discussion Threads

[wan] 31/5/2018 07:36

Impressive news regarding EKF's Renalytix AI PLC today.

What is very exciting is not only the potential for a substantial re-rating from a valuation of zero for EKF's sTNFR biomarker technology assets and subsequently indirect exposure for EKF shareholders to AI, but also the opportunity to participate in any separate equity funding of Renalytix AI PLC, which looks like it may be an excellent way for existing EKF shareholders to enter the AI investment space directly.

AI start-ups are currently attracting very high interest, with very large fund raising being achieved and subsequently huge valuations!

[wan] 21/5/2018 08:07

Another article on the exciting prospects for artificial intelligence (AI) in healthcare -

20th May 2018
AI can reduce UK cancer deaths by 10%, says Theresa May
Prime minister sets targets for science and artificial intelligence


In a speech in Macclesfield, the UK prime minister will set targets for a “whole new industry around AI-in-healthcare” in Britain, initially centred around key research cities of Edinburgh, Oxford and Leeds.

Full story FT.com -

[wan] 17/5/2018 09:50

To better highlight my point that the FDA approval marks an important juncture; Compared with the traditional tests used to diagnose diabetes (fasting blood glucose, oral glucose tolerance testing, and recently laboratory-based A1C), point-of-care A1C testing offers a number of advantages, particularly rapid diagnosis and early initiation of therapy. Laboratory-based A1C is already an accepted diagnostic test for diabetes, but regulatory authorities and clinical guidelines were yet to endorse point-of-care devices for diagnosing diabetes.

Hence my point that it happened last week -


Let's hope EKF's Quo-Test is next in line for approval for both the monitoring and diagnoses of diabetes.

[wan] 17/5/2018 09:33

Alere's Afinion already had FDA approval for the measurement of whole blood glycosylated hemoglobin (HbA1c) to be used to monitor long term blood glucose control in patients 'previously' diagnosed with diabetes.

I note that last week Alere's Afinion also achieved FDA approval to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes. To my knowledge this is the first point of care A1c product to achieve FDA approval for the diagnosis of diabetes and it marks an important point in terms of the FDA accepting A1c can be used in the 'diagnosis' of diabetes.

Recall that EKF have conducted a number of clinical trials in the USA
in anticipation of submitting applications for FDA approval in the USA for their Quo-Test products. One assumes that the trials are likely to have been to also confirm the use of Quo-Test in the diagnosis of diabetes, which means that the potential market for A1c will be much larger than just the monitoring of blood glucose control, which in any regard is a very large market!

There are some other differences between the Afinion and Quo-Test analyser other than price, but I thought the price differences are notable -

Cost of the Afinion analyser = $3,856
Cost of a pack of 15 HbA1c Afinion cartridges = $159

Cost of Quo-Test analyser (£ to $ conversion) = $2,260
Cost of a pack of 15 HbA1c Quo-Test cartridges (£ to $ conversion) = $90


Apparently draft agreements are in place with OEM partners in the USA for Quo-Test A1c (and DiaSpect).

EKF are hoping to achieve FDA approval for their Quo-Test products in the first half of 2018.

[wan] 16/5/2018 08:01

Recall the following from back in January -

About Us : News and Events
RenalytixAI (An EKF Diagnostics subsidiary) is raising funds to develop AI for tracking kidney disease

RenalytixAI, an EKF Diagnostics (EKF) subsidiary company, is raising $25m (£17.6m) to float one of its divisions in America and then use the funds to develop artificial intelligence for tracking kidney disease.


Cardiff-based EKF Diagnostics, which makes medical devices to monitor blood glucose levels and hemoglobin analyzers, hopes the new company (RenalytixAI) can help it secure deals with big hospital groups across the US.


RenaltyxAI will mine data from medical records and biobanks to help doctors predict which patients with type one and two diabetes will go on to develop chronic kidney disease — enabling physicians to intervene early. If untreated, diabetic kidney disease can progress to end stage renal disease, so early detection can drastically improve patient outcomes.


Julian Baines, chief executive of EKF, will become chairman of the new company and he will be looking to inject cash into the company within the next six months. “With chronic kidney disease, 90% of the time people find out too late,” he said. “With our technology, patients will be tested and can monitor their progress using their mobile phones."

[wan] 16/5/2018 07:36

A good article on the exciting prospects for artificial intelligence (AI) in healthcare -

Opinion Healthcare costs
AI can help tame America’s exploding healthcare costs

Autonomous technology can make clinical decisions, allowing for convenient diagnosis

That’s why the prospect of autonomous AI in healthcare is so exciting. With autonomous programs, the AI makes the clinical decision without specialist supervision. This not only saves time, but also makes it possible to diagnose patients in more convenient locations: primary care clinics and other local settings.

Full story in the FT -

[wan] 04/5/2018 10:29

One assumes that what is in the pipeline makes sense to carry out a buyback of shares. In other words, EKF are clearly getting their house in order for when when it also makes sense to start paying a dividend.

EKF have a large installed base of instruments, which is growing and that generates reliable recurring revenues i.e. very cash generative.

[interstellar] 04/5/2018 09:03

Share buy backs are a distortion and manipulation of the financial pictures going forward. WHy not instead do something really outstanding and almost unprecedented for a fledgling medical AIM company and issue a dividend.

[wan] 04/5/2018 07:39

I am still confident that EKF will realise further growth events in the near term. In the interim, I note the new special resolution for the buy back authority at the AGM next week -

6. That the Company be and is generally and unconditionally authorised for the purposes of section 701(1) of the Companies Act 2006 (the “Act”) to make one or more market purchases (within the meaning of section 693(4) of the Act) on the London Stock Exchange of ordinary shares of £0.01 each in the capital of the Company (“Ordinary Shares”) provided that: the maximum aggregate number of Ordinary Shares authorised to be purchased is 68,633,195 (representing approximately 15 per cent. of the Company’s issued ordinary share capital); the minimum price (excluding expenses) which may be paid for such Ordinary Shares is £0.01 per share; the maximum price (excluding expenses) which may be paid for an Ordinary Share shall not be more than 5 per cent. above the average of the middle market quotations for an Ordinary Share as derived from The London Stock Exchange Daily Official List for the five business
days immediately preceding the date on which the Ordinary Share is purchased; unless previously renewed, varied or revoked, the authority conferred shall expire at the conclusion of the Company’s next annual general meeting or 30 June 2019, if earlier; and the Company may make a contract or contracts to purchase Ordinary Shares under the authority conferred prior to the expiry of such authority which will or may be executed wholly or partly after the expiry of such authority and may make a purchase of Ordinary Shares in pursuance of any such contract or contracts.

[9degrees] 12/4/2018 07:01

Thanks wan Interesting research

[wan] 11/4/2018 07:45

I was catching up on the supporting evidence for sTNFR1, and thought that some readers may also be interested.

The following is interesting and not just because of the predictive accuracy of the test, but also the potential of test to dramatically reduce the number of patients required in clinical trials, and furthermore that the evidence also suggests that the TNF receptor could be a therapeutic target, which would mean the test could yield far greater use as a companion diagnostic in any resulting therapeutic application (and in clinical trials for such) -

Published on: April 20, 2017
Joslin's New Test Finds Patients With Diabetes at High Risk of Kidney Failure

“Remarkably, when we use the TNF receptor to analyze risk of ESRD, the risk was almost identical for both type 1 and type 2 diabetes,” Krolewski said in a statement. “This implies that the etiologies are similar. This is a very important observation because in the medical community, the impression is that the progression of ESRD in type 1 is somehow different from type 2. As a result, many clinical trials do not include patients with type 1.”

Also, he said, it could mean that the TNF receptor is a therapeutic target.

Finding better ways to identify and treat those at risk of ESRD would save millions if more patients could avoid dialysis. The cost of ESRD is so high—dialysis centers bill commercial insurers up to $200,000 a year per patient—that these patients occupy a special category of Medicaid, since so few could pay for care on their own.

Because the test more accurately pinpoints who is at risk of ESRD, Krolewski said it could be used to dramatically reduce the number of patients needed for clinical trials. “If our criterion is used in the recruitment of patients, you will not need 2000 to 3000 patients for a clinical trial; you will only need 400 patients.”

Full article -

Further validation -

January 2018
Validating the association between plasma tumour necrosis factor receptor 1 levels and the presence of renal injury and functional decline in patients with Type 2 diabetes.

Author information
1
Diabetes Complications Research Centre, Conway Institute of Biomolecular and Biomedical Research, School of Medicine, University College, Dublin, Ireland.
2
Department of Endocrinology, St. Vincent's University Hospital, Dublin, Ireland.
3
Clinical Chemistry, St. Vincent's University Hospital, Dublin, Ireland.
4
Diabetes Complications Research Centre, Conway Institute of Biomolecular and Biomedical Research, School of Medicine, University College, Dublin, Ireland; Department of Gastrosurgical Research & Education, Sahlgrenska Academy, University of Gothenburg, Sweden; Investigative Science, Imperial College London, United Kingdom.
5
Diabetes Complications Research Centre, Conway Institute of Biomolecular and Biomedical Research, School of Medicine, University College, Dublin, Ireland; Department of Gastrosurgical Research & Education, Sahlgrenska Academy, University of Gothenburg, Sweden. Electronic address: [e-mail].

Abstract
AIMS:
Elevated plasma soluble tumour necrosis factor receptor 1 (TNFR1) predicts long-term progression of chronic kidney disease. We investigated the association between elevated TNFR1 and the presence of renal disease in patients with Type 2 diabetes mellitus registering a haemoglobin A1c (HbA1c) >48mmol/mol despite medical therapy.

RESULTS:
Upper quartile TNFR1 is independently associated with elevated urinary albumin-creatinine ratios, reductions in eGFR and strongly predicts the presence of stages 3-5 chronic kidney disease in regression modelling. Elevated TNFR1 levels are associated with increased plasma C-reactive protein and augmented leptin-adiponectin ratio.

CONCLUSIONS:
Our study confirms plasma TNFR1 as a surrogate of renal structural and functional impairment in patients with type 2 diabetes mellitus. Association of TNFR1 with markers of systemic inflammation and adipose stress indicates that TNFR1 may be a biomarker of these processes as components of the pathogenesis of diabetic kidney disease.

Link -

[wan] 09/4/2018 09:43

Fwiw, I think we will get to know more about the commercial strategy in the US once the Quo-Test products are approved (which I am expecting). Given the size of the commercial opportunity in the US that the combined approvals will enable, it will, in my opinion, have 'already' drawn strong interest from potential distribution partners.

[wan] 09/4/2018 09:28

N+1 Singer analyst Chris Glasper has published commentary today in which he described news from EKF of FDA 510k approval and CLIA Waiver as “very positive news” and asserts that “the potential opportunity is material for EKF”, with a “$35m+ market for point of care testing in the US to go at”.
Forecasts remain unchanged at the moment but he writes:

“We make no changes to our estimates, pending confirmation of the commercial strategy, which we expect in the coming months. We continue to see meaningful upside to the current share price on this and other opportunities in the pipeline.”

N+1 Singer currently forecast £43.4m revenue for 2018, adj EBITDA of £10m and £7.5m adj PBT. For 2019 these rise to £44.7m, adj EBITDA of £10.8m and adj PBT of £8.0m.
(END)

Indeed I concur ;-) I also see material upside.

[woodcutter] 09/4/2018 09:27

been accumulating here over the last week. strong cash flow good balance sheet and top quality products with strong market position. todays news should add to the positive share price advance aimho.

woody

[wan] 09/4/2018 07:25

With today's announcement of the US Food and Drug Administration approval of EKF's DiaSpect Tm, for use in point of care and Certificate of Waiver settings, we have an excellent start to the first half, but I don't think the good news will stop here! From the FY Results -

Outlook
We are looking forward to finalising our two FDA applications in the first half of 2018, and to update on progress with our sTNFR project. At the same time, we anticipate receiving completed registrations for Beta Hydroxybutyrate (β-HB) in
Mexico, Brazil and Colombia as well as the Indian registration of DiaSpect Tm all in the first half of 2018.
(END)

These registrations/approvals, if achieved, will have a material and positive impact on revenues going forwards!

[wan] 04/4/2018 15:48

I would add that managing chronic Kidney Disease (CKD)/End Stage Renal Disease (ESRD) via new technology/techniques could potentially provide big reward and importantly a step change in social care/patient benefit. A focus on prevention and management could help to reduce the number of cases and therefore the treatment costs associated with CKD and ESRD. For example, the staggering annual medical costs in the US have been estimated at over $98 billion (yes apparently that's the correct estimate!) for Medicare beneficiaries.

[wan] 04/4/2018 15:27

An interesting price breakout today on no new news!

I can see some news flow regarding managing End Stage Renal Disease via artificial intelligence, but nothing specifically relating to EKF yet.

[ingroid] 21/3/2018 12:25

Mac/ Wan: the various medical implications wan has been putting through have been helpful background for the ordinary person to try to understand what is possible for future expansion. The spin off details are still not in place but progressing,nothing definite or in place yet. Clinical trials taking place in USA, aim is to achieve sales expansion there, S.America and China. Building on existing growth of streamlined group and further capital expenditure in Germany. Nice to hear and see persons managing company.My comment to wan earlier appears to have moved the shares by the market makers ?

[macarona] 21/3/2018 11:16

Ingroid,
Is it possible to share your valuable insight with the rest of us, fellow shareholders?

Thanks
Mac.

[wan] 21/3/2018 09:02

Thanks Ingroid. I was invited, but I was unable to attend the EKF meeting.

I would very pleased to receive any interesting material etc. Perhaps you could highlight the material/details via a personal ADVFN message?

[ingroid] 21/3/2018 08:23

Great article wan.went to the open analyst /shareholder meeting late Thursday afternoon. Very enlightening . May have interesting material and facts from it for you to digest if there is another way for contact.

[wan] 16/3/2018 07:30

EKF has put the Times article on their news page -

RenalytixAI (An EKF Diagnostics subsidiary) is raising funds to develop AI for tracking kidney disease

RenalytixAI, an EKF Diagnostics (EKF) subsidiary company, is raising $25m (£17.6m) to float one of its divisions in America and then use the funds to develop artificial intelligence for tracking kidney disease.

Cardiff-based EKF Diagnostics, which makes medical devices to monitor blood glucose levels and hemoglobin analyzers, hopes the new company (RenalytixAI) can help it secure deals with big hospital groups across the US.

Full story -
hxxps://www.ekfdiagnostics.com/renalytixai-an-ekf-diagnostics-subsidiary-is-raising-funds-to-develop-ai-for-tracking-kidney-disease.html

[wan] 14/3/2018 08:00

Another good set of Results with net cash improving further, despite making a number of investments in the business and with borrowings reduced significantly to £1.2m.

The sTNFR venture now talks about numerous partners, which is an interesting development.

[wan] 29/1/2018 07:29

I don't think it will work like that, hence no announcement today!

It will be a new entity listed in the US, so for me it's about how much the assets/technology has been valued at, and how much of the new entity will EKF own.