Ekf Diagnostics Share Discussion Threads

[wan] 05/10/2022 14:29

I note that recently EKF retweeted a Walbrook PR tweet -

EKF diagnostics written up with a "continue to buy" recommendation in Oct edition of the Techinvest Newsletter

"We see considerable potential for growth across all of EKF’s business units and the current strategy seems well conceived."


Aligns with my own thoughts and actions.

[wan] 27/9/2022 08:16

EKF's Advanced Diagnostic Laboratory (ADL) website homepage has been updated -


ADL has also launched their comprehensive PreCheck™ Prenatal NIPT national screening webpage -

Recall the following from the Interims -
At the beginning of the year, we signed a strategic partnership agreement with Yourgene Health plc ("Yourgene") to offer a non-invasive prenatal test ("NIPT") service from our accredited US laboratory. We expect this service to launch in October 2022 and we believe this is an exciting growth opportunity.


And from the Strategic partnership agreement with Yourgene -
The adoption for NIPT in the US has accelerated with recent guidelines issued from American College of Obstetricians and Gynaecologists ("ACOG") recommending NIPT to be made available to all pregnant women(1) . As part of the agreement, Yourgene will provide ADL Health with access to YGEN's proprietary reagents and NGS analysis software as part of a technology transfer agreement to enable ADL Health to build a rapid turnaround NIPT service for the US market. Currently, a majority of US NIPT samples are sent to large central testing laboratories, which are costly and experience lengthy lead times . In contrast, the new ADL NIPT service will offer rapid turnaround times as the NIPT workflow can be performed in as little as 48 hours, enabling a competitive response and allowing both EKF and Yourgene to gain traction in this large growing market. According to third party forecasts, the US NIPT market is expected to reach a valuation of USD 2.5 Billion by 2028(2).


PRECHECK™
PRENATAL NIPT
Enhancing existing prenatal screening pathways for pregnant women with fast, reliable results while reducing the need for invasive tests and the associated patient stress and anxiety.

Non-Invasive Prenatal Testing

[wan] 21/9/2022 10:57

I note the article and comment from the IC below, which has a hold recommendation. One would assume though from the following comment "The company is outperforming compared with pre-pandemic figures, but it must articulate a new direction", that whilst EKF is indeed outperforming, the articulate part was surely made/published prior to the live webcast, because in my view, the management articulated very well indeed regarding the overall business and indeed the new direction.

EKF Diagnostics initiates post-Covid transformation
The company is outperforming compared with pre-pandemic figures, but it must articulate a new direction.
September 20, 2022
By Jennifer Johnson


The IC also refer to "The transition of Contract Manufacturing and Laboratory Services into non-COVID-related revenues is our key challenge." which was stated in the Half Year Report. However, that challenge, when reading only the results, didn't come across in the same way as from the webinar and Interim Presentation, which appeared quite upbeat in terms of the progress to date and the future prospects.

EKF is indeed transitioning though, but to an increasingly sophisticated and diverse global medical diagnostic business, and positioning EKF for very much long-term sustainable growth.

My questions were apparently submitted too late to be considered as part of the Q&A (I was unable to attend the live event).

Interim Results Presentation September 2022 -

[wan] 20/9/2022 10:04

EKF is weathering the general market backdrop of supply-chain challenges and inflationary input-cost pressure well thus far, as well as maintaining course in the planned changes and investment in the transition towards their next phase of growth.

A couple of items that recently caught my attention -

Optimized for molecular testing.
Salorn STM is a virucidal, bacteriostatic, Guanidine-free sample collection device, offering highly sensitive antigen testing capabilities.

Salorn STM replaces PrimeStore ATM with a new Triton-X free formula and equivalent activity.

Albeit still accepting orders for research use only.*


5th July 2022
UK Health Security Agency issues report validating PrimeStore MTM inactivation of Monkeypox Virus

PrimeStore Molecular Transport Medium
Product code R13907 (Thermo Fisher Scientific)


Regarding the last point, I have raised a question for the meeting later this afternoon regarding Monkeypox sample collection demand (which will not be in the league of COVID testing), as clearly testing is being performed -

Date Issued: July 15, 2022

The U.S. Food and Drug Administration (FDA) is advising people to use swab samples taken directly from a lesion (rash or growth) when testing for the monkeypox virus. The FDA is not aware of clinical data supporting the use of other sample types, such as blood or saliva, for monkeypox virus testing. Testing samples not taken from a lesion may lead to false test results.

The FDA has said that it does not plan to object to tests being offered that are developed and performed in a CLIA certified laboratory where the tests use PCR technology and lesion swabs, where the tests have been validated and the laboratory notifies the FDA.

Preparation and Collection of Specimens
Updated August 26, 2022

[wan] 13/9/2022 10:05

Interesting -

There are lots of recommendations in the American Association for Clinical Chemistry (AACC) and American Diabetes Association (ADA) 2022 draft Consensus Report for Public Comment regarding the use of HbA1c testing in the management and 'diagnosis' of diabetes (Recommendation: Laboratory-based HbA1c testing can be used to diagnose diabetes), which provides food for thought.

The latest proposed 2022 draft guidelines and recommendations for laboratory analysis in diagnosis and management of diabetes also include the following recommendations, including a Glycated Albumin test, a test for which EKF has exclusive distribution rights in the US -

Recommendation: POC HbA1C testing for diabetes screening and diagnosis should be
restricted to FDA approved devices at CLIA-certified laboratories that perform testing of moderate complexity or higher. B (low)

Recommendation: Assays of other glycated proteins, such as fructosamine or glycated albumin, may be used in clinical settings where abnormalities in red cell turnover, hemoglobin variants or other interfering factors compromise interpretation of HbA1c test results, although they reflect a shorter period of average glycemia than HbA1c. GPP

Recommendation: HbA1c cannot be measured in individuals who do not have HbA, e.g., those with homozygous hemoglobin variants, such as HbSS or HbEE; glycated proteins, such as fructosamine or glycated albumin, may be used. GPP

GPP = Good Practice Points (GPPs) are recommendations mostly driven by expert consensus and professional agreement, and are based on the below listed information and/or professional experience, or widely accepted standards of best practice. This category mostly applies to technical (e.g. pre-analytical, analytical, post-analytical), organizational, economic or quality management aspects of laboratory practice. In these cases evidence often comes from observational studies, audit reports, case series or case studies, non-systematic reviews, guidance or technical documents, nonevidence-based guidelines, personal opinions, expert consensus or position statements. Recommendations are often based on empirical data, usual practice, quality requirements and standards set by professional or legislative authorities or accreditation bodies, etc.


ADA/AACC Laboratory Analysis Consensus Report for Public Comment
The American Association for Clinical Chemistry (AACC) and American Diabetes Association (ADA) are posting for public comment a draft of the “Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus” consensus report. The 2022 draft for public comment updates key areas where new evidence has emerged since the 2011 publications.

The public comment period is September 1, 2022 through September 30, 2022. Please email [e-mail](link sends e-mail) with comments.

[wan] 08/9/2022 07:59

A couple of items that caught my attention -

Our team will be presenting EKF Link and our Diabetes monitoring devices at the event Point of Care Innovations in Bristol, UK. Don't miss out!

Join us at Point of Care Innovations on 20 September 2022 to learn all about the EKF Diagnostics point-of-care range including HbA1c analyzers, glucose analyzers and hemoglobin analyzers for use in the screening, monitoring and diagnosis of patients as well as rapid tests for pregnancy and common infectious diseases.

EKF's point-of-care (PoC) analyzers are designed for use within doctors' surgeries, clinics, hospitals and laboratories to provide fast and accurate results at an affordable price.

By definition, PoC testing is carried out in the presence of the patient allowing open dialogue between them and the practitioner. In this way patients benefit from receiving medical advice during the course of a single visit.

All EKF point-of-care analyzers and consumables are CE marked; there are also CLIA waived products within the portfolio.



Given EKF's range of point-of-care analysers, their growing portfolio provides food for thought regarding the following -

Sep 7, 2022
Pharmacy-Based Testing Sees Growing Legislative, Commercial Momentum
Changing business models and new legislative initiatives are driving point-of-care testing in pharmacies in the wake of the COVID-19 pandemic.

[rivaldo] 06/9/2022 12:03

Keith Ashworth-Lord's CFP SDL Free Spirit Fund have this morning issued their monthly factsheet for September, and have this to say about EKF:

"EKF Diagnostics (+11.4%) was the second-best performer following a reassuring trading update at the beginning of the month showing strong growth in the core business. Post update, the investment team visited the Cardiff HQ to meet with Marc Davies, CFO and Gavin Jones, Head of Product Management.

In addition to us passing the haemoglobin and glucose testing with flying colours, we came away impressed by the financial controls put in place by Marc in the relatively short period of time that he has been with the company. The discussion included plans for new product development, US fermentation capacity expansion and the transition away from Covid-related revenues within its contract manufacturing division."

[wan] 02/9/2022 07:26

Interview re the Lucica® test which is distributed exclusively by EKF in the USA -

Lucica® Glycated Albumin-L Test for diabetes: Comparisons and Clinical Utility With Shane O’Neill
Published: September 1, 2022
Lucy Lawrence & Tiffany Quinn

In this episode we are joined by Shane O’Neill, director of scientific affairs at EKF Diagnostics. Shane provides an introduction to the glycated albumin (GA) test for intermediate-term glycemic control in diabetic patients.

The GA test is now FDA-cleared and available for use in the United States. It was developed by Asahi-Kasei Pharma of Japan (Lucica® brand) and is a standardized and well-evidenced method for determining glycated albumin levels in the serum.

Shane will also describe why glycemic control is important and discuss the value of the test for glycemic monitoring, outlining its clinical utility and how it compares to other markers of glycemic control, such as hemoglobin A1C and fructosamine.

[wan] 01/9/2022 07:21

I note todays RNS re notice of Interim Results and the related live online presentation hosted by Mike Salter (CEO) and Marc Davies (CFO)

Excerpt from an article by Jeff Fischer, President, Longhorn Vaccines and Diagnostics -

MEDCITY INFLUENCERS, DIAGNOSTICS

A Covid-19 reflection: Incorporating what we’ve learned for improved preparedness
Beyond preparedness policies, we need to think forward to policies that rapidly identify the spread of zoonotic disease to prevent or minimize the impact.
By JEFF FISCHER

Aug 31, 2022

Evolving toward better preparedness

The silver lining of the situation was that the diagnostics industry was able to respond and flex to the unexpected as we navigated new territory, albeit with some transition bumps and learnings along the way. One important change the industry has made is in expanding our lab capacities. We moved from a pre-pandemic molecular testing rate of 40 to 50 percent to PCR tests now comprising about 70 to 80 percent of volume. We are getting better at maintaining adequate capacity and scaling to meet increased need.

We’re also finding a good balance between test sensitivity versus speed, or rapid testing. Throughout the pandemic, we’ve had to reassess the best test for each particular point in time. Prior to vaccine availability, there was a need to focus on sensitivity because testing was the only tool available to manage the virus. We needed to know with certainty who had Covid-19 so that we could contain the spread and provide early medical care.

As we moved into a vaccine environment and Covid-19 mortality decreased, testing convenience became more important, and with it, a greater uptake of antigen testing. Antigen testing has limitations: it is a less effective containment tool and doesn’t lend itself to accurate caseload reporting. However, it has a role.

As we began to understand the best utility for each type of test, we also discovered their limitations. Antigen tests may not be the best option during a period of rapid and aggressive spread. PCR tests are more accurate, but can’t provide as quick an answer. We discovered that antibody testing was not as helpful as we initially thought it might be and that knowing whether someone had had Covid-19 previously was not as important as knowing whether they were currently carrying the virus.

Additionally, we entered a period of lab innovation that has streamlined and improved processes in long-lasting ways. Covid-19 assays were developed at record speeds and have potential to inform future assay development for other pathogens. At-home test kits, previously subject to a variety of hurdles, have benefited from eager uptake by consumers. Hospital labs developed tightened result turnaround times with the promise of better testing experiences for patients across a range of conditions for years to come.

Transport media that inactivates dangerous pathogens in patient samples now offers improved protection of workers, safer and faster collection and enables temperature-agnostic transport and storage. Solutions such as these have gained an integral place in everyday workflows in the short period of time since they were introduced.

Full article -

[wan] 25/8/2022 18:19

Cisk...Well we know EKF diversified its customer base so as not to be overly reliant on any one large public sector client (no guarantee that it was Amazon).

Anyway, there is far more to the story than that particular Amazon headline implies, including further potential healthcare acquisitions by Amazon -

Amazon Care and Care Medical are shutting down. Is it really that big a deal?
25th August 2022

A healthcare corporate venture capitalist lauded the “rational decision” that Amazon took in deciding to shut down Amazon Care and Care Medical.

“I love how Amazon keeps trying to crack the employer health market – first with Haven, then with Care and now with One Medical,” said Michael Yang, managing director of OMERS Ventures, the venture arm of the the pension plan for Ontario’s municipal employees, in an email.

The retailer is spending a pretty penny — $3.9 billion — to acquire One Medical though the deal hasn’t closed yet. Yang noted that the San Francisco company has a “far more substantive footprint in the employer market” in comparison with Amazon Care.

In other words, the fact that Amazon is acknowledging failure and moving on, is really not a big deal and doesn’t change the company’s growing ambitions in healthcare. So does the failure even matter?

“Well, healthcare is hard, so we should expect failures but if anything their ambitions are only getting bigger,” Yang said of Amazon. “Whether they kept Care going or shut it down is immaterial. The big deal is One Medical and whatever else they pursue.”

Another healthcare industry player and thought leader agreed.

“[Amazon] previously had a skunk works (Amazon Care and Care Medical) and [it] basically acquired a scaled, clinical operation with the right clinical and regulatory controls in place (One Medical),” said Sachin Jain, CEO of SCAN Health Plan, a Medicare Advantage plan. So, this might just be a fancy way of saying that they’re collapsing that Amazon Care into One Medical,” [Note that the One Medical acquisition is not complete yet.]

In other words, “they are playing to win and realize that building it organically wasn’t going to cut it,” Yang declared, adding that he won’t bet against Amazon despite this setback.

Even after the much-touted Haven floundered, there were similar sentiments: you can’t count Amazon out, you can’t bet against it. But selling healthcare services isn’t like selling books or any other consummable and faster, better, cheaper may not exactly translate to great outcomes.

“I’m not close to the Amazon Care story, but there’s a broader trend in our industry that is replacing specialists with generalist doctors, replacing physicians with nurse practitioners, replacing nurse practitioners with RNs, replacing RNs with community health workers,” Jain pointed out. “And unless you’re kind of founded with really strong clinical DNA, lots of organizations are going to make a lot of mistakes and it’s, you know, it’s not, it’s not clear where that DNA was going to come from, you know, within Amazon.”

Perhaps this is why Amazon isn’t exactly stopping with the acquisition of One Medical. Reportedly, it is also one of the suitors bidding for Signify Health that is a value-based care company with a market cap of $6.6 billion. Based in Dallas, Signify Health is powering in-home health services, the next place rife with opportunity in healthcare. Sitting within Signify Health is also another company it bought called Caravan, which supports accountable care organizations. In fact, Caravan has within its client base more than 200 health systems and 100 Federally Qualified Health Centers with more than 10,000 primary care providers that collectively manage over 500,000 patients, according to a February MedCity News article.
Full article -

Amazon to close US telehealth service as it shifts sector ambitions
Tech group seeking more access to corporate employees in bid to gain foothold in $4tn healthcare market
25th August 2022

Analysts said Amazon Care’s closure, which will come at the end of the year, should not be seen as a retreat on its efforts to gain a foothold in the $4tn US healthcare sector. “This is not a sign of failure by any means,” said Natalie Schibell at Forrester Research. “It’s a strategic move.”

Amazon’s decision comes after its recent agreement to acquire One Medical, a large network of primary care providers, for $3.9bn — its largest deal in the healthcare space.


Amazon’s ambitions in healthcare have been years in the making, and are set to intensify under the leadership of Andy Jassy, who replaced Jeff Bezos as chief executive last year.

Ultimately, Amazon’s M&A activity points to it assembling the building blocks for a large health service offering “value-based care”, said Rebecca Springer, a senior analyst covering healthcare at PitchBook. The term describes a business model where health providers earn income based on patient outcomes — how well the patient is — versus merely providing treatments.

Full article, FT.com -

[cisk] 25/8/2022 15:57

Impact on EKF?

[tongosti] 22/8/2022 15:56

I feel this is wider markets led. However a firm close below 36 (if and when it happens) will invite a completely neutral stance on this.

[tongosti] 16/8/2022 09:46

48 captured intraday chaps. Didn't take that long did it. First milestone out of the way.

[tongosti] 16/8/2022 08:56

Doing what's it meant to be - 48 to be captured v soon. Once we have that in the bag, 63 is the next stop.

[zxie] 16/8/2022 08:29

INSP shares jump soon

[tongosti] 15/8/2022 09:16

Allowing for a bit of time to price consolidating around 48 area, one should then expect 63 as the next stop after that. On the balance of odds.

[wan] 13/8/2022 11:52

Yes, interesting and encouraging positive price action yesterday.

In my view, there is quite a lot of positive development to report, which the Trading Update indeed implied. I am therefore looking forward to EKF reporting their interim results more fully in September.

Following the related healthcare and diagnostic sectors as I do, I am also very much encouraged regarding EKF's prospects as we enter the next chapter of their growth phase.

[tongosti] 12/8/2022 20:30

Glad to see a few have finally got some colour on their cheeks. All four of them....As you can see chaps there is a time to be long and a time to be short. And another one to get back long again. 48 is next.

[sharw] 12/8/2022 16:24

Looks like a tipsheet.
8 trades before 14 22 and 61 since.

[saucepan] 12/8/2022 15:50

Very encouraging price action.

[tongosti] 09/8/2022 08:55

48 is next immediate milestone if we close firmly above 41.

[faz] 05/8/2022 16:58

James, I think you're right, EKF doesnt have the money as its spending it on internal growth. SO it's a waste of Baines for sure. However it also does not have the money because I'd guess the idea was to sell the shares in RENX etc at a marvellous profit and use that to invest in new Sinai spin offs. The stories given when the three spin offs were made also did not indicate they were cash-hungry punts.

[wan] 05/8/2022 10:17

Hi James,

I don't disagree regarding the share performances, nor the fact it's 'hopefully' still too early to judge those spinout shares. But as I said back in April, for those of us still holding the extended family of EKF stocks, on the one hand we are still better off than we were without the in-specie shares (unless you participated directly), but the overall performance thus far is more than disappointing, to say the least! I also suggested that given the market backdrop, going forwards, one wonders if the spin-off model has any immediate candidates, or indeed any further legs at all.

In my view, Verici and Trellus (trading at near or below cash) are more likely to be acquired than require additional funding, but only time will tell. With regard to Verici, with strong IP and scientifically validated tests, it is worth noting that other related transplant players have IP issues, but plenty of cash and/or the financial firepower on tap.

On the one hand the market is hardly conducive or receptive to further spinouts atm, and perhaps especially so given the dire performance of the previous spinout shares. To my mind, one or more of those spinouts will have to perform and deliver before there is any appetite for any further opportunities.

Personally, I would like to see EKF invest and develop their own IP, or at least the development of proprietary products. In this regard, I repeat in part what I stated back in May as a result of an answer to my question at the AGM -

EKF are not developing proprietary tests/assays per se (or at least not yet), they will however produce both proprietary EKF enzymes as well as third party enzymes that can be produced in bulk scale for mass production of test kits, such as molecular testing, and indeed in other application areas too e.g. buffer formulations (watch this space👀).

So, proprietary, high margin, enzymes might be an example of an aspect that's underappreciated, as clearly, such enzymes could generate significant value, as well as providing potential to increase EKF's attraction to new and existing partners (already happening in my view), and as well as extending EKF's own moat.

In this regard, the partnership with ABEC to deliver customised, large-scale bioprocess equipment to EKF's specific manufacturing requirements is perhaps particularly worthy of note.

Elsewhere, I note development of a unique fermentation platform to 'sustainably' produce high-quality molecules through fermentation. Such 'bespoke and specialised' fermentation platforms will enable a consistent, scalable, and reliable supply of high-quality functional molecules.

In short, EKF are leveraging their extensive manufacturing capabilities and many years of experience to respond to demand-driven opportunities in a very specialised, attractive, high growth areas. With the recent Trading Update providing increased confidence in terms of core business recovery, expansion, and indeed the delivery of the Growth Strategy.

[james188] 04/8/2022 20:31

faz,

I think that you ask some legitimate questions in relation to the various companies that have been spun out of the Mount Sinai/EKF relationship. I should say that I am a reasonably long term investor in EKF.

The share price performance of the three companies that you mention has obviously been disappointing (ditto the EKF share price), but they are all cash hungry early stage entities and I think that it is too early to make a definitive judgement.

I do not think that EKF is large enough to financially further support these investments. They will all inevitably need to raise further funds and so there is a significant risk of dilution as EKF will struggle - and much more so its shareholders - to participate. EKF has much better use for its cash in growing the core business (which is doing well). It is worth noting that EKF has not spun out a further company for some time and rejected a deal that was put forward last year. That may signify a change in strategy under the new management team.