Ekf Diagnostics Share Discussion Threads

[wan] 09/7/2021 07:49

Jeff Fischer
Co-Founder, President Longhorn Vaccines and Diagnostics LLC
15 hrs ago

Point of Care (POC) testing for sarscov2 and influenza will be a significant component in pcr testing for the foreseeable future. Thank you to the roche team for providing equipment and assays for validation. PrimeStore MTM now validated on all major POC PCR platforms #liat #cepheid #biofire #genmark providing safer workflow.


I am still watching point of care testing (POCT) developments and so is Luke Daum, Chief Scientific Officer and Executive VP at Longhorn Vaccines and Diagnostics, who particularly follows and likes LumiraDx -



The potential for PrimeStore ATM is why I am watching POCT development/evaluations etc. And fits well with EKF's rationale in providing the picks and shovels for Covid-19 testing.

[wan] 08/7/2021 09:40

I also posted recently that regular testing is expected to replace the disruptive self-isolation regime, and given the significant rise expected/forecast in infection rates over the next few months, testing volumes will likely increase accordingly......and probably significantly!

To add weight to that view and strong possibility, the following frames it quite well -

Business warns of England work chaos from delay to ending self-isolation

Up to 2m people a week at risk as Sajid Javid’s lighter testing regime set for mid-August

George Parker, John Burn-Murdoch and Oliver Barnes in London JULY 6 2021

Health secretary Sajid Javid admitted there could be a record 100,000 new Covid cases a day if most remaining restrictions are lifted on July 19 as planned. The projected number of daily cases would far exceed the 61,240 new daily cases when the virus peaked on January 1.

But recent data show that a ratio of two people are asked to isolate for 10 days per original case, suggesting that if 700,000 a week were infected a further 1.4m could be asked to self-isolate.

With cases doubling every nine days, Javid said the country was entering “uncharted territory” but that the “wall of protection” offered by coronavirus vaccines would allow new rules on self-isolation to apply from the middle of next month, arguing that death rates would remain low.

He said any adult who had received both jabs would no longer have to self-isolate if they had been in close contact with a person who then tested positive for Covid-19.

Contacts would be advised to take a PCR test and self-isolate if they tested positive. Those receiving a second dose around August 16 would need to wait two weeks for the vaccine to be fully effective.

Full story FT.com -


And possibly more than one PCR test -

7th July 2021
What are the new self-isolating rules in England?
From 16 August, anyone in England who is a close contact of someone who tests positive for Covid will no longer have to self-isolate if they've had both their jabs.

When they are notified about their contact, the NHS Test and Trace app will ask if they are fully vaccinated.

If so, they will be advised to take one PCR test as soon as possible to make sure they haven't been infected. As long as that test is negative, and they don't develop symptoms, they won't need to take further PCR tests.

However, anyone who tests positive or develops symptoms will still need to self-isolate, regardless of their vaccination status.

People who have a second vaccine dose close to 16 August will have to wait two weeks after the jab before following the new rules. This is to allow the vaccination to take full effect.

[wan] 08/7/2021 09:29

Re: the above, I forgot that I posted previously (post 2092) That Mark Weaver,
EKF Diagnostics Regional Sales Manager (Western Europe/ DACH) posted that PrimeStore MTM is being used routinely with Roche LIAT systems in the NHS. This ensures viral RNA integrity which minimises false negative results and keeps NHS staff safe!

So, it appears that it is the preferred choice of the NHS, and rightly so!

[wan] 08/7/2021 07:40

I note the following news release (reported previously on here 1st July)

Study validates PrimeStore Molecular Transport Medium® for use with respiratory collection of clinical oral and nasopharyngeal swabs on Roche’s point-of-care cobas® Liat® System

July 07, 2021 08:00 AM Eastern Daylight Time

BETHESDA, Md.--(BUSINESS WIRE)--Longhorn Vaccines & Diagnostics, a privately held biotechnology company developing molecular-based collection and testing reagents, today announced milestone study results in The Journal of Applied Laboratory Medicine from the American Association for Clinical Chemistry (Oxford Academia). The research article, “Rapid and Safe Detection of SARS-CoV-2 and Influenza Virus RNA Using Onsite qPCR Diagnostic Testing from Clinical Specimens Collected in Molecular Transport Medium,” is the first published study to bridge the PrimeStore Molecular Transport Medium® (MTM), an FDA cleared collection device, with Roche’s cobas Liat®, a point-of-care FDA approved diagnostic system for simultaneous detection of SARS-CoV-2 (COVID-19) and influenza A/B viruses.

For SARS-CoV-2 and influenza A/B viruses, the necessity for safe sample testing, which includes RNA/DNA inactivation, is important to preserve the dignity of each sample and to ensure lab technicians are handling secure transport tools. Since clinical swabs are inactivated and RNA/DNA is preserved in PrimeStore MTM®, processing and running patient samples on the Roche Liat® System provides a safe alternative to commercial viral/universal transport medium, particularly at urgent care clinics and doctor’s offices for near-patient care.

Full release -


Clearly, a safe alternative for lab technicians should be the default for point of care settings. So, it will be very interesting to see if it's indeed the preferred choice.

[wan] 07/7/2021 10:24

Edit to above post, full title added to final link -
Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening

[wan] 07/7/2021 09:17

I note with interest the following confirmation of Amazon's Covid-19 test kit launch -

Amazon launches at-home COVID-19 test collection kit for customers
Written by Amazon Staff
July 6, 2021

Amazon’s new testing kits offer customers a convenient, accurate, and affordable way to test for COVID-19.

Amazon’s top priority throughout the COVID-19 pandemic has been the health and safety of our employees and customers. We’ve invested billions in that effort, including building an in-house COVID-19 testing program to ensure front-line employees have access to free, regular testing with state-of-the-art diagnostic laboratories in the U.S. and the UK.

These labs have processed millions of tests from over 750,000 of our front-line employees, making Amazon a leader in employer-driven COVID-19 testing. We learned a lot through that process, and we’re excited to extend this reliable and convenient COVID-19 testing service to our customers through Amazon.com.

The Amazon COVID-19 Test Collection Kit DTC has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Customers can use the test collection kit at home, and the kits are processed by Amazon’s in-house laboratory using a sensitive method known as RT-PCR, which is considered the current “gold standard” diagnostic approach by the U.S. Centers for Disease Control and Prevention.

“Even as COVID-19 vaccinations continue, widespread access to reliable and affordable COVID-19 testing remains a critical tool in the fight against the spread of the virus,” said Cem Sibay, the Amazon vice president at the helm of the company’s COVID-19 testing work. “The Amazon collection kit offers customers the convenience they’ve come to expect from Amazon.com by providing access to COVID-19 testing whenever and wherever they need it. The test collection kit provides highly accurate and timely results, helping customers feel more confident as they safely return to travel, work, college, and daily life.”

The collection kit is now available to U.S. customers on Amazon.com for $39.99 and does not require a prescription. It is authorized for use by individuals 18 years or older, with or without COVID-19 symptoms. The collection kit includes Amazon Prime delivery at no additional cost. It’s also easy to use and requires a quick sample collection using a gentle, lower nasal swab. The process, including test registration and collection, takes less than 20 minutes to complete.

The collection kit is FSA and HSA eligible and comes with pre-paid next-day return delivery to Amazon’s state-of-the-art diagnostics laboratory in Hebron, Kentucky. Customers will receive test results within 24 hours of their sample arriving at the lab, and results are available through Amazon's secure website AmazonDx.com.


Recall that the Amazon kit utilises both PrimeStore MTM and Phosphate Buffered Saline e.g unsupervised and supervised testing, and thus has wide utility -

Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening -

LoD Comparison: PrimeStore MTM vs Phosphate Buffered Saline
Phosphate Buffered Saline (PBS) offers advantages over PrimeStore MTM in terms of supply chain logistics and ease of use due to the absence of potentially hazardous preservative fluid, making it suitable for use as a transport medium for unsupervised home collection of specimens

[wan] 07/7/2021 07:11

Worthy of note, today's Trading Update MyHealthCheked -

RNS Number : 3729E

MyHealthChecked PLC

07 July 2021

Trading update

MyHealthChecked Plc (AIM: MHC), the consumer home-testing healthcare company, provides an update on trading for the six months to 30 June 2021 a period of transformation, investment for growth and increasing commercial traction. The financial information is based on unaudited management accounts.

Key highlights

-- H1 Revenues dramatically increased to GBP3.27m (H1 2020: GBP12,700) driven by COVID-19 testing services

-- Cash balances of GBP2.21m despite investment in staffing and inventory (H1 2020: GBP1.35m)
One of the key features of the period was the successful acquisition and integration of The Genome Store at the end of 2020. The subsequent launch of the MyHealthChecked brand, and the launch of the ecommerce website and service, delivers on the key strategic aim of growing the Company's product portfolio into other areas of personalised health and wellness. Whilst the Company's new genomic testing service has been successfully deployed to offer a COVID-19 testing service, it provides the foundation to create a wider portfolio of easy to use DNA tests over the longer-term.

The COVID-19 testing service has been the main commercial driver of performance in the first half. MyHealthChecked's services have been included as one of the suppliers on the Government list with "Fit to Fly", "Test to Release" and "Days 2 and 8" testing, and the Company has established a key commercial partnership with Boots UK Limited ("Boots") . The MyHealthChecked COVID-19 at-home nasal swab kit and PCR laboratory testing service launched in April via www.boots.com and across over 500 Boots stores in Great Britain. MyHealthChecked subsequently signed a second agreement with Boots to provide COVID-19 test kits and laboratory testing services for day two and day eight coronavirus testing for international arrivals, which launched mid-May.

As a result, there has been a significant uplift in sales for the period, particularly driven by higher COVID-19 testing revenues during May and June. Revenues for the six months to 30 June 2021 were GBP3.27m (H1 2020: GBP12,700), with just over GBP3m of these sales booked in the final two months of the period. Whilst customer discussions are ongoing and there is still no certainty over ongoing volumes of sales, it is likely that these increased revenue levels will continue into the summer and will have a positive impact on the results for the financial year ending 31 December 2021.

Cash balances at 30 June 2021 were GBP2.21m, reflecting investment in personnel and marketing in readiness for commercial growth, and higher than normal inventory costs during the period as stock is built up in anticipation of continued strong sales in H2 when the company expects to be cash generative (H1 2020: GBP1.35m).

The Company remains very optimistic about the business prospects for the full year. Post period end MyHealthChecked acquired Nell Health Ltd, a technology-led provider of genetic testing and personalised nutrition consultancy services. Nell Health's innovative technology platform offers personalised accessible and actionable outcomes to improve health and wellness based on information gathered from a Nell Health DNA test. Beyond this the acquisition also gives MyHealthChecked a fully-owned technology platform that will enable the Company to retain full ownership and IP for all of their future digital technology

Penny McCormick, Chief Executive Officer of MyHealthChecked Plc, said:

"The first half of 2021 has seen a transformation of our business ready to capitalise on the commercial opportunities before us. As I explained in our recent Full Year results, we are now a business with a highly credible, compliant and successful pharmacy customer, a high street presence, a proven service, and with an operational and commercial set-up which is now delivering growth in a regulated product, poised for the needs of the market as we enter a new period of social freedoms in 2021.

"Whilst this is an exciting opportunity, we are mindful to ensure a strong pipeline of genetic tests outside of COVID-19 to secure the firm foundations of a business backed by robust science and innovative technology that can deliver long-term sustainable revenue growth."

The persons responsible for arranging the release of this Announcement on behalf of the Company are Penny McCormick, CEO, and Gareth Davies, Chief Financial and Operations Officer respectively.

[wan] 06/7/2021 08:01

Apparently, later this week it will be announced that regular testing is expected to replace the disruptive self-isolation regime, and given the significant rise expected/forecast in infection rates over the next few months, testing volumes will likely increase accordingly......and probably significantly!

[wan] 02/7/2021 08:12

And as a reminder and to put the above into at least some context, from EKF's 2021 – 2024 Growth Strategy Investor Presentation w/c 7 June 2021 -

2. Exploit newly expanded capabilities to meet the demand for contract manufacturing services
Leverage relationship with private sector partner to support their diagnostics strategy

EKF currently makes kits for their COVID sample collection product in USA,
UK and Germany

Customer is the largest distribution business in the world

Leveraging distribution business to move into ‘home diagnostics’

EKF perfect partner due to manufacturing capabilities in US, Europe and UK

EKF also a key regulatory partner

Collaborating on new molecular enzyme product to be made in Elkhart

Reliant on EKF for all diagnostic advice

Increasing demand for kit manufacturing

Substantial revenue and EBITDA growth opportunity

Page 8 -

[wan] 01/7/2021 05:58

Staying with the attributes of PrimeStore MTM and the ability to rapidly detect SARS-CoV-2 and influenza virus infection from a single sample -

Mark Weaver
EKF Diagnostics Regional Sales Manager (Western Europe/ DACH)

Great to see this publication. PrimeStore MTM is being used routinely with Roche LIAT systems in the NHS. This ensures viral RNA integrity which minimises false negative results and keeps NHS staff safe!

Luke Daum
• 3rd+
Chief Scientific Officer and Executive VP at Longhorn Vaccines and Diagnostics
13h • Edited • 13 hours ago

Thrilled that my clinical research using Roche's cobas Liat for SARS-CoV-2 (#covid19research) is finally published in The Journal of Applied Laboratory Medicine (Oxford University Press) and available online here:


The Liat® is a multiplex system capable of simultaneous detection of SARS-CoV-2, and influenza A and B RNA from patient samples -

Rapid and Safe Detection of SARS-CoV-2 and Influenza Virus RNA using Onsite qPCR Diagnostic Testing from Clinical Specimens Collected in Molecular Transport Medium
Luke T Daum, Gerald W Fischer
The Journal of Applied Laboratory Medicine, jfab073, hxxps://doi.org/10.1093/jalm/jfab073
Published: 22 June 2021

[wan] 30/6/2021 08:55

Worth reading and keeping firmly in mind as the flu season approaches, that PrmeStore MTM enables testing for both COVID-19 and influenza from a single sample -

PrimeStore® MTM
An explanation of the differences
between Molecular Transport Media
and Viral Transport Media

Summary
The main difference between MTM and VTM
is that molecular transport media, such as
PrimeStore® MTM, will fully deactivate viruses,
bacteria, fungi and mycobacterium tuberculosis,
allowing safe sample handling and transport to
greatly reduce infection risk.

PrimeStore MTM is a FDA cleared and CE IVD
marked infectious disease sample collection,
storage and transport system which was
specifically developed to overcome the short
comings of standard viral transport media
(VTM) and universal transport media (UTM)
that do not inactivate microbes and can also
inhibit molecular testing.

In Conclusion

The novel, patented sample
collection device, PrimeStore® MTM
allows COVID-19 samples to be
rapidly inactivated in the collection
tube. This immediately eliminates
infection risk and also preserves
nucleic acids for downstream
molecular processing without need
for refrigeration.

In addition to removing the need
for expensive cold chain transport
and storage of samples, RNA and
DNA are perfectly preserved by
PrimeStore MTM for up to four
weeks. This means that it is ready
for safe testing immediately on
arrival at a laboratory and without
need for containment. In the case of
COVID-19, this opens up options for
more testing laboratories, making
this device a key part of the testing
supply chain which can underpin the
safe and rapid increase of testing
capacity.

PrimeStore MTM is also being used
during the coronavirus pandemic
by a number of businesses to
provide COVID-19 testing services
for their staff. This is enabling
them to bring back those who
may be self-isolating due to
concerns over infection, or that of
a family member. The fact that it
also enables laboratories to test
for both COVID-19 and influenza
from a single sample will also be
greatly beneficial as the flu season
approaches.

[wan] 29/6/2021 08:03

Interesting and encouraging EKF comments in the above interview. I have already been looking (quite closely) at testing for diabetic Ketoacidosis, for which EKF already has a very strong position, but there is real potential for EKF to become the global leader in my view, perhaps especially so with the increasing use of sodium-glucose cotransporter 2 (SGLT2) inhibitors, which apparently raises the risk for diabetic ketoacidosis. I am thus expecting further developments in the specific area of B-HB (perhaps even a tie-up with Renalytix and or its pharma partners?).





CLIA waived point of care test -

[brummy_git] 29/6/2021 05:22

Just in case you missed it yesterday.

Marvellous insights from Christopher Mills of Harwood Capital - a world class investor - talking about top quality stocks, such as EKF Diagnostics.

Heaven personified

www.linkedin.com/posts/paul-hill-a5994116_vox-markets-fund-manager-interview-with-chris-activity-6815288599295123456-BgJJ

[wan] 26/6/2021 06:04

Link added to above post (I forgot to include the link to the April news article, for comparison etc)

[melody9999] 25/6/2021 13:51

Great research Wan thanks

[wan] 25/6/2021 08:50

Interesting 'private sector' development -

Readers may recall that back in April (as reported on here) that Amazon said that it was launching the next phase of its Amazon Web Services (AWS) Diagnostic Development Initiative, in which it plans to distribute $12 million this year to fund projects for SARS-CoV-2 testing, as well as for other infectious disease diagnostics.

AWS also said it will prioritize COVID-19 projects but will also evaluate projects focused on other infectious diseases. The company will accept applications through the end of the year, with priority given to applications received before July 31.

"We have seen transformative innovations in how we diagnose disease over the past year, from machine learning-powered X-ray imagery analysis to new developments in rapid, high quality, and direct-to-consumer tests," Vin Gupta, chief medical officer of Amazon's COVID-19 response unit, said in a statement. "These changes will continue to evolve and improve our ability to respond to future outbreaks. We have already seen inspirational results from the Diagnostic Development Initiative, and we look forward to supporting broader uses of cloud technologies to enable organizations and communities to identify and respond even faster to future outbreaks."


It would appear that that initiative has indeed evolved, and I note that AWS has updated the initiative and increased the funds available to $20 million -

The Amazon Web Services (AWS) Diagnostic Development Initiative (DDI) is a two-year, $20M commitment to accelerate research and innovation to advance the collective understanding and detection of COVID-19 and other infectious diseases in order to mitigate current and future outbreaks. AWS is offering AWS Promotional Credits and technical expertise to support the use of AWS services for projects by selected institutions and companies in four program areas: early disease detection, diagnostics, prognosis, and public health genomics.

[tongosti] 23/6/2021 12:01

Mr Market not made its mind up yet on this bad boy. Practising extreme patience and biding my time before I get involved.

[wan] 23/6/2021 08:49

The article below follows up on the news that I previously posted regarding AWS. Suffice to say that as an EKF investor, and with digital innovation fast becoming the next frontier in healthcare, I am very pleased and encouraged that EKF's management have their fingers on the pulse, investing accordingly (spinouts included) and demonstrating that EKF is very relevant now and into the future -

Jun 22, 2021
Amazon Continues Its Bold Expansion Into Healthcare, As AWS Launches A New Healthcare Accelerator

Furthermore, AWS’ initiative is by no means a new frontier for Amazon. In fact, Amazon has increasingly been venturing into the healthcare space, indicating its interest in potentially becoming a key market player in the industry one day. One significant example is Amazon Care, a relatively new virtual care platform aiming to provide patients with comprehensive care. The platform explains that in addition to enabling real-time access to clinicians, “nurses will come directly to you for testing, immunizations, blood draws, and more,” and that the service will “deliver Amazon Care prescribed medications right to your door.” Indeed, if history indicates any relevant marker of success, Amazon’s attempt to enter the rapidly growing digital care market could potentially be an industry game-changer.

Ultimately, this new initiative by AWS provides renewed perspective that digital innovation is the next frontier in healthcare. Undoubtedly, companies, organizations, and government entities must invest in and prioritize these initiatives if there is any hope of continuing to stay relevant in healthcare in the years to come.


Everyday Care
Now Available: Primary And Preventive Care Services

[wan] 23/6/2021 07:55

I note from EKF's FY Presentation that EKF secured agreements with two reference labs to add Glycated Albumin to their portfolio.

[wan] 23/6/2021 07:49

The Lucica® glycated albumin test is distributed exclusively by EKF USA.


EKF are exhibiting at the 81st Scientific Sessions Event by American Diabetes Association Jun 25, 2021, 3:00 PM - Jun 29, 2021, 9:00 PM -

EKF introduces 3 new products to our expanding diabetes test portfolio: Glycated Albumin, STAT-Site® WB for clinical use and BIOSEN-R for research use.

The Lucica® method for Glycated Albumin (GA), manufactured by Asahi Kasei Pharma Corporation, is a specific enzymatic test for GA that is now FDA cleared for sale in the U.S. The Lucica® test is distributed exclusively by EKF USA. The Lucica® test is one of the most widely used and published GA methods worldwide. Lucica® Glycated Albumin-L can fill the gap between long-term and short-term glycemic control markers.

The STAT-Site® WB Dual Analyte Measurement System from EKF Diagnostics is used for the quantitative determination of β-ketones (Beta-Hydroxybutyrate or βHB) and glucose in capillary and venous blood. The STAT-Site® WB is intended for whole blood multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program.

BIOSEN-R is a dual channel, bench top analyzer for lactate and glucose measurements for research lab use (RUO). The measurement principle is enzymatic-amperometric and can measure glucose and lactate in a variety of sample types, including venous, arterial and capillary blood, plasma, serum, fermentation broth, cell culture media.

[wan] 22/6/2021 08:13

Given Julian Baines new role, which will focus on delivering further value from the Company’s relationship with Mount Sinai Innovation Partners (“MSIP”), I found the following recent news items quite interesting, although any direct relevance to EKF of course remains to be seen -

New York, NY (June 08, 2021) Mount Sinai Innovation Partners (MSIP), the commercialization engine of the Mount Sinai Health System (Mount Sinai) in New York City, has launched Elementa Labs, a virtual incubator program that aims to position health care and biotechnology startup companies for the next stage in their development.

The program empowers companies to strategically align with Mount Sinai, gaining access to subject matter experts in health care and the potential to advance their core technology platforms. Participating companies will work directly with a Mount Sinai champion who will facilitate navigation within the Health System and enable access to key stakeholders, resources, and know-how to advance product development.

“Elementa Labs will integrate Mount Sinai’s research and clinical expertise with the business and product development infrastructure of health care startup companies,” said Erik Lium, PhD, President of MSIP and Chief Commercial Innovation Officer of Mount Sinai Health System. “We look forward to engaging with entrepreneurs to bring health care innovations to the patient population.”


I found the following Amazon Web Services announcement quite interesting too -

AWS Public Sector Blog
AWS announces AWS Healthcare Accelerator for startups in the public sector
by Sandy Carter | on 21 JUN 2021

The healthcare industry is currently experiencing seismic shifts with much of the focus being placed on COVID-19 clinical, operational, and financial efforts. However, even in the setting of the pandemic, the healthcare industry is still faced with addressing a growing aging population, a widening workforce gap, and a proliferating volume of healthcare data. Healthcare organizations, from hospital systems to public health agencies, have been turning to technology solutions to help them quickly adapt and respond to these challenges and rapidly innovate with data-driven and compliant solutions. To support both high-potential healthcare startups and the healthcare industry need for innovative solutions, we are excited to announce the launch of the Amazon Web Services (AWS) Healthcare Accelerator program.
Full release -

[wan] 21/6/2021 09:29

Coming onto radars?

Most readers will know that EKF and Kantaro Biosciences partnered to market quantitative COVID antibody testing in UK and Europe.

The Kantaro COVID-SeroKlir kit is a direct ELISA for the quantitative detection of human IgG antibodies to the SARS-CoV-2 virus in serum and plasma (K2-EDTA/Li-Heparin) samples. COVID-SeroKlir has FDA Emergency Use Authorization (EUA) in November 2020 having previously received a CE mark in October 2020.

COVID-SeroKlir has demonstrated 97.8% sensitivity and 99.6% specificity for detecting SARS-CoV-2 specific IgG antibodies against two virus antigens, the full-length spike protein and its receptor-binding domain. COVID-SeroKlir is a two-step enzyme-linked immunosorbent assay (ELISA) and can be used by any certified laboratory* without the need for proprietary equipment.


Given the success and indeed acceleration in vaccinating populations, the conversation is perhaps changing in terms of the need to determine the level of immunity (conferred by infection or vaccination), but perhaps more importantly for how long that immunity lasts i.e. do we need booster jabs, or perhaps more to the point, when. The following provides for an interesting read -

Why Antibody Testing Should Be Our Next Tool in the Fight Against COVID-19
June 15 2021
Keir Lewis