Ekf Diagnostics Share Discussion Threads

[sharw] 09/11/2022 11:57

Another difference is that SBI only has 16.48% of shares in private outside hands while EKF has 42.87% so more difficult to get a delisting resolution through (requires 75%).

[supernumerary] 09/11/2022 11:10

SBI was an inside job from the start - came out of private equity, who immediately set about banking their profits by selling down, in the process benefiting from the covid windfall. The constant selling and total lack of any attempt at publicising the company made it untouchable for outside investors, hence the silly share price So now they're back where they started they plan to rinse and repeat. Probably hoping that when they've got their sticky little fingers on it, they can find a major to buy them out. Nice work if you can get it.

Not I hope a comparator for EKF.

[p1nkfish] 09/11/2022 10:46

Case by case.
SBI price action was saying something recently.
EKF a different kettle of fish.

[james188] 09/11/2022 09:12

Note what has happened over at DourceBio (SBI) today and start to worry. As a holder, I certainly am. Christopher Mills is a repeat offender for this sort of thing. I will not invest in another publicly listed company with which he/Harwood are involved. Very poor behaviour, in my view.

[wan] 04/11/2022 10:30

Staying with testing for pathogens.

Due to the pandemic many more consumers are now familiar with self-testing, hence there is a notable pivot, described by some experts as ‘paradigm shift’, by both large and smaller diagnostic companies to direct-to-consumer/near-patient multiplex testing which covers a broader range of pathogens (beyond just COVID-19), including testing in the doctors office, pharmacy, at-home self-testing, and self-collect samples that are then processed at the lab such as EKF's ADL Health, including EKF's ADL pathogen panel that I highlighted in post 2896.

The article further below provides some context in terms of the pivot, and provides food for thought with regards to the innovative nature of ADL's pathogen panel, which includes detection of 47 Pathogens including 9 Resistant Gene Markers to decrease the spread of infection, including COVID-19, and comes with an extraordinary 24 hour turnaround time -

Quest broadens access to COVID-19 multiplex tests as flu cases rise
The new procedure is meant to encourage the use of tests that detect multiple respiratory viruses as the U.S. prepares for a challenging flu season.

Published Nov. 3, 2022

Quest Diagnostics is broadening access to its multiplex test to detect flu and COVID-19, letting patients self-collect samples for the test at its 1,600 testing centers across the U.S. Previously, patients had to make an appointment at a testing site, where they were swabbed by a clinician.

Quest said it made the changes to improve testing access as respiratory illnesses increase.

Flu cases have been rising in the U.S., and cases of influenza-like illness are higher than in recent years, according to the Centers for Disease Control and Prevention. Cases of respiratory syncytial virus (RSV), which affects young children and older adults, are also increasing.

Quest also offers a combined COVID-19, influenza and RSV test to be used by physicians in clinical settings. Several other diagnostic companies have developed their own multiplex tests, most of which are used by clinicians.

In 2021, Salt Lake City-based BioFire Diagnostics got de novo clearance for its BioFire respiratory panel, a molecular test that it says can detect 22 respiratory pathogens, including SARS-CoV-2.

Labcorp also received an emergency use authorization (EUA) in 2020 for a multiplex test for COVID-19, flu and RSV that physicians could use to diagnose patients and make decisions about treatment. More recently, it won authorization to offer a version of the test where patients swab at home, though the results are still processed in a lab.

Full article -

Not to mention that the over-the-counter and direct-to-consumer testing pivot no doubt provides opportunity (amongst a number of others) for EKF's expanded production and kitting capabilities to offer a suite of diagnostic Contract Manufacturing solutions to third party businesses:

EKF has contract manufacturing sites in the UK, Germany and the USA. Across these locations we can provide scalable solutions to support all business types, from start-ups to industry leaders. The solutions include assistance with configuring your product, sourcing materials, providing state-of-the-art formulation and dispensing facilities all the way through to services such as kitting, labelling and packaging.

Worth reading in full -

[wan] 04/11/2022 08:45

Longhorn Vaccines & Diagnostics Recognized as BioTech Breakthrough’s “Diagnostics Company of the Year”

Award Recognizes Innovation in the Global Life Sciences and Biotechnology Industry

November 03, 2022

Longhorn Vaccines & Diagnostics, a One Health and One World company developing vaccines and diagnostic tools for global public health and zoonosis concerns, today announced it has been named “Diagnostics Company of the Year” in the second annual BioTech Breakthrough Awards program. BioTech Breakthrough is a leading independent market intelligence organization that evaluates and recognizes standout life sciences and biotechnology companies, products, and services around the globe.

“We’re deeply honored to receive this recognition. Our goal is to improve the delivery of molecular diagnostics to serve critical unmet needs in both the developed and developing world,” said Longhorn Vaccines and Diagnostics President Jeff Fischer. “Since 2006, we have been developing products in preparation for a universal pandemic. From the Covid-19 pandemic to the rise in RSV, influenza, and tuberculosis cases today, our products allow public health officials and medical personnel to have the tools to achieve the medical outcomes they expect no matter the situation—and be prepared for the next infectious disease.”

“The testing for pathogens such as influenza as well as any antimicrobial resistance, has rapidly transitioned from live culture—which is time consuming—to molecular testing. Live culture often requires complex biological containment facilities and can take days or weeks. Meanwhile, molecular testing is significantly faster, highly sensitive, and once the sample is properly inactivated, can be done in a variety of healthcare settings,” said Managing Director of BioTech Breakthrough Awards Bryan Vaughn. “Longhorn’s unique diagnostic solutions thrive in a wide variety of environments, helping to diagnose and treat infectious diseases such as influenza and most recently SARS-CoV-2 and Monkeypox. We offer a heartfelt congratulations on being our choice for ‘Diagnostics Company of the Year!’”

Currently, Longhorn is expanding its diagnostic division towards testing supplies for African swine fever, avian influenza, and a wide range of pathogens and sample types with the goal of preventing the spread of contagious viruses. As just one example, the United States Department of Agriculture recently expanded its use of PrimeStore MTM to facilitate the tracking and surveillance of the Avian influenza strain that is making its way through the U.S. poultry population.
Full release -

[9degrees] 03/11/2022 16:28

ex div today I think

[tongosti] 01/11/2022 15:23

Wan - what you need to learn pal is tune out everything and listen to Mr Market. He gave the sell signal at 80. He also gave the signal to buy back in at 36. I guess you have a fair bit to get back to break even - enjoy, all I am saying is never let a roller coaster experience like this go to waste.

[wan] 01/11/2022 15:05

Heads-up via Walbrook PR -

EKF to showcase POCT connectivity solutions at MEDICA 2022
1st November 2022

Powerful digital connectivity products and contract manufacturing capabilities in Hall 3 at Stand B69

EKF Diagnostics, a global diagnostics company, will be introducing its latest product developments and offerings at MEDICA 2022, Düsseldorf, Germany, 14-17 November. Highlighted at the event will be its newly introduced point-of-care testing (POCT) connectivity solutions, including the enhanced DiaSpect Tm hand-held hemoglobin analyzer and the new EKF Link digital connectivity software. In addition to its POCT products, EKF will also highlight its growing contract manufacturing services to the healthcare industry.

In Hall 3 at Stand B69, the EKF team will be available to demonstrate how its new state-of-the-art EKF Link middleware enables healthcare providers to readily manage their POC analyzers and all generated data via one centralized platform. An intuitive, open solution, EKF Link can be interfaced to most vendor’s POC analyzers, in addition to EKF’s own portfolio. This facilitates real-time remote management and secure transfer of data, including patient test results, QC results, operator management and analyzer configuration within a range of healthcare settings.

Adding to the ever-growing list of POC analyzers that are compatible with EKF Link, the enhanced DiaSpect Tm hemoglobin analyzer now offers calculated hematocrit values, and its rapid test results can be securely sent to centralized Laboratory Information Systems (LIS) or Patient Information Systems (PIS). The palm-sized analyzer’s new digital connectivity capabilities enabled by EKF Link also allows authorized users to easily access its near-patient results through a web browser, whatever their location, supporting seamless patient care.

EKF will also be highlighting its global contract manufacturing capabilities covering configuration of product, sourcing materials, providing state-of-the-art bulk formulation and dispensing facilities, through to services such as kitting, labelling and packaging. With extensive facilities in the USA, UK and Germany, EKF has a proven track record of developing and manufacturing quality products for a range of markets, industries, and businesses - from start-ups to industry leaders – across the globe.

MEDICA 2022 brings together industry leaders, global healthtech professionals, start-ups and experienced high-tech products in the medical technology arena.

Discussing how EKF’s contract manufacturing team has supported his start-up health technology company, Elliot Quigley, Project Manager, Proton Dx, said: “EKF Diagnostics has been instrumental in our development as a company. They worked above and beyond their remit to ensure the successful completion of our pivotal milestones. They worked closely with our team to provide solutions and guidance navigating the tricky start-up landscape, whilst providing top-tier products.”

Mike Salter, CEO, EKF Diagnostics, said: “We look forward to welcoming visitors to our stand at MEDICA where our team of product and contract manufacturing specialists will be on hand to discuss our broad range of medical diagnostics products and manufacturing services. We are particularly excited to be able to demonstrate our enhanced capabilities in POCT connectivity which provides hospitals, laboratories and clinicians with the ability to manage and evaluate their patient and user data easily and securely.”

[wan] 30/10/2022 08:26

Food (including healthcare products) for thought.

It may serve EKF investors well to consider keeping an eye on the Cannabis/Cannabidiol market and its participants, as development and commercialisation is transitioning towards what looks to be a steep growth curve in terms of commercial activity and product launches. The announcement below is for sample availability following a previous multi-year processing and distribution agreement -

Purissima Announces the Official Launch of First Fermentation-Derived, Natural CBC for Sale in Partnership with Open Book Extracts
(PRNewsfoto/Purissima)

Oct 27, 2022.

Biotechnology Innovator and Manufacturer Deliver First-to-Market Natural CBC using Microalgae Fermentation, Offering Formulators and Brands Access to an Essential, Rare Cannabinoid

SAN FRANCISCO, Oct. 27, 2022 /PRNewswire/ -- Purissima, a leading, multi-patented health and wellness biotechnology company, announced today the official commercialization and sample availability of their Cannabichromene (CBC) in partnership with Open Book Extracts (OBX). This launch follows the unveiling of Purissima's exclusive, multi-year processing and distribution partnership with OBX that was announced in July.

With this launch, Purissima is the first biotech company to reach commercial scale production of natural cannabinoids using microalgae fermentation. As part of the launch, Purissima is offering a discovery sample box containing CBC products such as a topical serum, gummies, capsules and tinctures, showcasing how CBC can be formulated in a multitude of consumer-friendly formats for anti-inflammatory and wellness benefits. Interested parties can visit purissima.bio or openbookextracts.com to inquire about wholesale sourcing of CBC and CBC formulations, pure CBC samples or discovery boxes.

Full release -

Not that I am expecting cannabis testing to the only exposure EKF have to this market, but EKF's ADL Health has developed an analysis of cannabis potency that can test for and analyse 11 different cannabinoids, and has also recently launched a new clinical toxicology method geared towards medication adherence, with the first samples being processed in September -

TESTING CANNABIS POTENCY
We are accredited by A2LA for the analysis of cannabis potency by HPLC/UV. Only accredited labs are on the state’s registered lab list. You can count on ADL Health for your cannabis testing needs.

Analysis
Testing method is High-Performance Liquid Chromatography/Ultraviolet-Visible Light Spectroscopy. 11 different cannabinoids are analyzed.


At ADL Health, our extensive experience and industry-tested laboratory processes bring you the best toxicology services.

Our panels have been researched to be clinically relevant, yet innovative. With state-of-the-art instrumentation and robust, science-driven methodologies, we detect what is important to your needs.

Prescription Compliance & Illicit Drug Panel
We test for 57 drugs across 13 classes to identify possible substance exposure and the presence of both prescribed and illicit drugs.

[wan] 28/10/2022 09:55

Above post edited

[wan] 28/10/2022 09:50

More arrows being added to the EKF quiver -

The tests I highlighted above have now all gone live.

Picking just one of the tests that has gone live:

If my interpretation is correct, the Respiratory Pathogen (PCR) panel includes the detection of 47 pathogens including 9 resistant gene markers to decrease the spread of infection, plus this all in one panel includes COVID-19. With an impressive 24 hour turn around time, and minimizing the need for multiple collection samples, this test is hitting multiple targets with one arrow so to speak!

[wan] 27/10/2022 09:35

Recall from the Half-year Results -

In Laboratory Testing, our efforts remain focussed on utilising the expertise of Advanced Diagnostic Laboratory LLC ("ADL Health"), which specialises in high complexity testing, to bring new tests online and expand our CLIA laboratory testing portfolio beyond COVID assays. To this end, the team has recently launched a new clinical toxicology method geared towards medication adherence and developed an analysis of cannabis potency, with the first samples being processed this month. Further tests in oncology, wound health and women's health are on track to launch later in the year and into early 2023. 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.
(END)

EKF also stated in their accompanying Presentation that their collaborative approach was appealing to private hospital networks e.g. bundling their range of point of care tests (POCT) with EKF's laboratory testing. For example, EKF is working with a large maternity hospital in the US, where EKF is installing their range of POC instruments into the hospitals lab and building a range of tests based on a profit share after costs. And being a maternity hospital, one would assume that that will also include ADL's/Yourgene's Non-Invasive Prenatal Testing.

EKF have updated and listed an initial range of tests, with the non-invasive prenatal test ("NIPT") service being one of the live tests -

Specialties
Test Profiles

Currently Available

[wan] 23/10/2022 08:37

Large diagnostic companies have been reporting/guiding recently that they are experiencing and anticipating revenue growth and robust demand in their core non-COVID life sciences and diagnostic businesses, as well as seeing opportunities to deliver sustainable long-term performance.

With Quest Diagnostics, one of the largest U.S. laboratory testing companies, stating that their shift in emphasis away from COVID-19 is paying off.

Danaher reported double digit revenue growth and that the strength was broad-based.

And PerkinElmer guiding that it anticipates organic revenue growth, non-COVID organic revenue, and adjusted earning per share for the third quarter to exceed its prior guidance.

[wan] 20/10/2022 09:34

"This expands on the ever-growing list of analyzers that are compatible with the new state-of-the-art POC data management platform" -

EKF introduces hand-held hemoglobin analyzer with secure POC connectivity
17th October 2022

The hand-held hemoglobin analyzer now connects securely to EKF Link, the company’s own point-of-care (POC) middleware, enabling additional features including a calculated hematocrit value and data management. Available globally, the DiaSpect Tm has received an IVD CE-mark, FDA clearance and is registered in many more countries across all continents.

Ensuring test results are stored and accessed securely on a centralized platform, the enhanced DiaSpect Tm can now be connected to the recently released EKF Link middleware. This expands on the ever-growing list of analyzers that are compatible with the new state-of-the-art POC data management platform. EKF’s DiaSpect Tm is also now equipped with Bluetooth, internal storage for 4000 tests and QC results, as well as the capability to provide a calculated hematocrit value alongside the usual hemoglobin result.

Moving into a new era of POC connectivity, the DiaSpect Tm results are easily accessible from a web browser through EKF Link while being securely protected on the servers already available in most laboratories and hospitals. Patient and operator identification allow for better tracking of both staff competence and test results, and a Quality Control reminder function ensures compliance with ever tightening local regulations.

Commenting on the new introduction, David Wojahn, Hematology Product Manager for EKF Diagnostics, said, “Our new DiaSpect Tm will enable POC coordinators, operating rooms and screening programs to connect this fast and reliable photometric hemoglobin analyzer to Laboratory Information Systems (LIS) or Patient Information Systems (PIS) through EKF Link. Now with the EKF Link connectivity, DiaSpect Tm is an ideal POC solution enabling users to rapidly upload results from anywhere and power up their performance, delivering results directly alongside the patient or blood donor.

The DiaSpect Tm is an ideal POC hemoglobin analyzer as it is palm-sized, lightweight, robust and easily transportable. It can be used in any screening setting, even in challenging climatic environments. This is because its reagent-less microcuvettes have up to 2.5 years shelf life, even after opening, and are unaffected by temperature and humidity. Its ‘always-on’ technology enables professionals to start using the device immediately; and the rechargeable internal battery, which provides up to 40 days/10,000 tests continuous use, offers the flexibility of not needing a power source for weeks at a time.

[wan] 12/10/2022 07:56

EKF's comprehensive contract manufacturing webpage -

Why choose EKF Diagnostics as your contract manufacturing partner?
EKF Diagnostics services are built on the core values of flexibility, understanding, and expertise. Because no two jobs are ever the same we offer a tailored approach to every customer, whether you need an end-to-end solution or just require a knowledgeable partner to provide a partial service, we can support your business.

EKF has contract manufacturing sites in the UK, Germany and the USA. Across these locations we can provide scalable solutions to support all business types, from start-ups to industry leaders. The solutions include assistance with configuring your product, sourcing materials, providing state-of-the-art formulation and dispensing facilities all the way through to services such as kitting, labelling and packaging.

We understand the importance of quality, we work with our partners to ensure all product and manufacturing requirements are defined and documented to ensure we produce your product to specification whilst maintaining the highest quality standards.

When you partner with EKF you partner with a global diagnostics company that has a proven track record of developing and manufacturing reliable and quality products for a range of markets and industries.

Our Global facilities
Our Global Manufacturing sites have a range of facilities from controlled Laboratories and White Rooms to ISO Class 7 Clean rooms. EKF will ensure your product requirements are understood allowing the appropriate manufacturing environment to be identified.

Pilot production labs
Assess product feasibility and produce small scale production batches in EKF’s Pilot Production Lab. Whether you want to formulate a new reagent or pack a new kit, our skilled scientists and operatives will work with you to develop fit for purpose production and test protocols to take your concept to the next stage.

Contract formulation
EKF Diagnostics can offer scalable contract formulation. All of our sites have the capability to formulate from 20 to 800 Litre mixes with experience in formulation of many reagent types from Phosphate Buffered Saline to complex reagents for molecular kits.

Contract dispensing suites
Our verified dispensing lines are controlled by in-process checks to ensure accurate filling. Our semi-automated pumps allow a variety of volumes of reagents to be dispensed into a range of vessels. With options for manual dispensing lines for process flexibility or automated filling for speed, EKF will have the dispensing solution that best suits your project.

Kitting suites
Our adaptable white room suites can be used for manual or automated packing to maintain a fast and flexible workflow.

ISO Class 7 clean rooms
If your product is required to be manufactured within a clean room environment our sites offer ISO Class 7 controlled clean rooms as well as a fully trained team of operatives.

For an informative read, providing further details and information (beyond that detailed above)-

[wan] 06/10/2022 08:20

Indicating EKF's Advanced Diagnostic Laboratory (ADL Health) is well placed regarding the trend in hospital outsourcing providing high-quality laboratory services and access to innovative testing -

Quest Diagnostics to Acquire Outreach Lab Services Business of Summa Health

Transaction to broaden access to innovative, quality diagnostic information services powering affordable care in Ohio

Oct. 5, 2022 /PRNewswire/ -- Quest Diagnostics (NYSE: DGX), the world's leading provider of diagnostic information services, and Summa Health, a large integrated healthcare delivery system in Ohio, today announced a definitive agreement for Quest to acquire select assets of Summa Health's outreach laboratory services business, referred to as LabCare Plus, in an all-cash transaction.

Quest Diagnostics Incorporated logo. (PRNewsFoto/Quest Diagnostics Incorporated)

The aim of the transaction is to broaden access to innovative, quality and cost-effective laboratory services powering affordable care for communities in Ohio. Under the agreement, Quest's laboratories in Twinsburg, Ohio, and Pittsburgh will provide testing for physicians and patients serviced by LabCare Plus. Summa Health will continue to wholly own and operate its hospital labs providing laboratory services for inpatient and hospital-based outpatient care, along with its anatomic pathology services.

Assuming the transaction's completion, physicians and patients throughout Ohio will benefit from access to Quest's industry-leading and highly innovative test menu, broad health plan coverage, network of patient access sites throughout the state, and lower out-of-pocket costs for many services.

"Laboratory services are a critical and fast-evolving area of healthcare. As the nation's leader, Quest has the expertise, agility and breadth of innovation to deliver the enhanced capabilities that physicians and patients increasingly expect," said Ben Sutton, Chief Strategy Officer and President of Ambulatory Care and Clinical Service Lines for Summa Health. "With this relationship, patients and providers in Ohio will benefit from access to advanced laboratory capabilities supporting better health outcomes."

"Diagnostics provide the insights to deliver healthcare that is both high quality and high value. By helping top health systems like Summa Health optimize their lab strategies, Quest empowers better health and affordable care for more patients," said Steve Rusckowski, Quest Diagnostics Chairman, CEO and President. "We look forward to extending our reach to more communities in Ohio as we strive to build a healthier world."

Summa Health selected Quest Diagnostics following a competitive bid. The parties expect to complete the transaction in the fourth quarter of 2022, subject to customary regulatory approvals. Financial details of the transaction were not disclosed.

[tongosti] 05/10/2022 18:13

As per my 2861 (w price being at 35 then), the then trend reversal has held very well I the face of late market turmoil. Wan - good to see you getting some colour on your cheeks pal. All of them

[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.