Ekf Diagnostics Share Discussion Threads

[wan] 12/8/2020 07:44

Two stories that caught my attention -

AUG 11
AMA and others struggling to perform testing urge HHS to reprioritize COVID-19 guidelines

Strains in the supply chain include reagents, swabs, plastics, viral transport media and personal protection equipment

The organizations included in the letter said that updating testing prioritization is a "matter of critical importance."

"We are increasingly concerned about the serious strains being placed on testing services for COVID-19, the impact those strains have on our ability to provide timely medical care to our patients, and ultimately on our ability to contain the spread of this dangerous virus," the letter states.

The letter cites three main reasons for needing to reprioritize testing to put medically-needing patients first.

The first is that laboratories in hospitals and academic centers are struggling to perform testing and treat COVID-19 patients due to strains in the supply chain. Many labs have been unable to keep a supply of reagents, swabs, plastics, viral transport media, personal protective equipment and other items that they require.

THE LARGER TREND

HHS on Monday posted the July through December COVID-19 testing plans from all states, territories, and localities on HHS.gov.

For the plan, states were requested to detail how a minimum of 2% of the population would be tested each month as well as to submit a strategy to increase that number by the fall. Each state plan was required to include target numbers of tests per month, ensure adequate SARS-CoV-2 testing, and ensure testing plan provisions are in place to meet current and future surge capacity, including for nursing homes.

This letter follows Assistant Secretary for Health Admiral Brett Giroir's statements that COVID-19 tests' turnaround times are faster than what is being reported in the media.

He said that half of all tests are conducted in point-of-care settings, which can be returned in as quickly as 24 hours. The other half is sent to commercial labs, such as LabCorp, which say the average time to deliver results for the COVID-19 swab test is two to three days from the date of specimen pickup. For the COVID-19 antibody test, the average delivery of test results is one to three days from the date of specimen pickup.

ON THE RECORD

"Without adequate testing capacity to rapidly serve those with a medically indicated need for testing, we risk continued widespread transmission of this disease," the letter says. "We also threaten the ability of healthcare facilities to continue to offer critical medical services to those in need of care."

Full story -


AUG 11
HHS releases COVID-19 state testing plans

The plans include details on reaching vulnerable populations including minorities, immunocompromised individuals and older adults.

States must list laboratories that will perform tests, along with each laboratory's available platforms and capacity by month.

The overall goals for each state were determined in a federal-state collaboration considering multiple factors, including the rate of new cases, plans for mitigation, percent positivity, and other factors.

Each state plan is required to include target numbers of tests per month, as outlined in the Centers for Disease Control and Prevention's Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious Diseases guidance document.

Each state plan is required to ensure adequate SARS-CoV-2 testing, including tests for contact tracing and surveillance of asymptomatic persons to determine community spread.

Plans must also ensure testing plan provisions are in place to meet current and future surge capacity, including for nursing homes.

The plans should address any essential partnerships with academic, commercial, and hospital laboratories needed to meet testing demand.

THE LARGER TREND

In late July, the National Institutes of Health said it was investing $248.7 million in new technologies to address challenges associated with COVID-19 testing.

NIH's Rapid Acceleration of Diagnostics (RADx) initiative awarded contracts to seven biomedical diagnostic companies to support a range of new lab-based and point-of-care tests that could increase the number, type and availability of tests by millions per week as early as September.

With national demand estimated to be millions more tests per day above current levels, these technologies are expected to make a significant contribution to expanding the nation's testing capacity, NIH said.

To help meet the numeric testing targets for each state, the federal government has been procuring and distributing certain testing supplies that are in short supply -- namely, swabs and transport media solutions -- to each state and territory since May, HHS said.

Additionally, in May, the CDC awarded a total of $10.25 billion to states, territories, and localities to help implement the goals of each jurisdiction's testing plan. States, territories, and localities are expected to continue using these funds to purchase tests and related supplies, as necessary.

Full story -

[wan] 11/8/2020 15:37

It's frustrating, but I note the seller is still keeping things in check, and if we are anywhere near correct in our assessments, therefore making available upside still to be realised.

I thus align with others, and surely it's a case of keep buying?

[wan] 11/8/2020 12:35

Apologies in advance for the multiple posts today, it just how it comes together sometimes!

The COVID/healthcare situation has, and is, resulting in rapid changes in the diagnostics and life science sector. And in my view, there is a lot of weight forming behind the dynamics now in play, both associated to and beyond COVID-19, and in which diagnostics will play an increasingly important part.

In this regard, the following article provides for an informative read and a read across to EKF's (and Renalytix) relationship and agreement with Mount Sinai, which provides EKF with advanced access to data and innovative commercial opportunities arising from Mount Sinai Health System owned technologies managed by MSIP in the field of digital diagnostics.

Addressing Covid-19 is a data problem – here’s how the data community is harnessing healthcare data to solve it

Data can allow us to improve our public health response to the pandemic, but only if we enable data scientists with the right tools to harness those datasets.

By FRANK NOTHAFT
Aug 10, 2020

Hospital systems
Digital transformation has been a slow burn for most hospital systems, but Covid-19 has ignited an accelerated effort, especially in the move toward analytics of consolidated health records. Hospitals use multiple different Electronic Health Record (EHR) systems that have complex data storage and analytics architectures. These complex architectures mean that these systems can’t easily interact, making it difficult to collect all the data that will provide a complete picture of a patient, which is necessary for building accurate machine learning models. Ultimately, data scientists working with legacy EHR architectures spend more time freeing data from their EHR, and less time building innovative models that can improve patient outcomes.

Pharmaceutical and diagnostics companies
While hospitals meet immediate healthcare needs and governments focus on controlling the spread, many pharmaceutical and diagnostics companies are focusing their energies on developing diagnostic tests, treatments, and vaccines for Covid-19. These organizations need help analyzing both clinical and real-world observational health data to determine how a drug is being used both in clinical trial settings and compassionate use to treat patients impacted by the virus.

A lot of biopharma and diagnostics companies have been using data about the spread of coronavirus to adjust their clinical trials and manufacturing programs rapidly. With this data, they can make sure that medicines and tests are still getting to patients in need, and they can look at how the novel coronavirus is impacting patients in the disease areas that they are focused on.

Full story -

In short, EKF (and Renalytix) appear well placed for the accelerated revolution taking place in the integration of data and new digital health solutions.

[wan] 11/8/2020 11:12

Thanks for highlighting my typo Speedsgh, an error in my haste (and juggling more than one ball at a time). Now edited accordingly.

[speedsgh] 11/8/2020 10:47

Hi wan. I echo the several recent comments thanking you for sharing your invaluable research.

Point of note in your post 395...

"From the Trading Update 30th Spetember 2020..."

I assume you are referring to the Trading Update dated 14/7/20 which provided a trading update for the six months ended 30 June 2020?

[wan] 11/8/2020 09:28

I want to pick up a small but perhaps not insignificant point from the July Trading Update, which aligns with EKF's having more in the tank than PrimeStore MTM alone to drive future earnings.

From the Trading Update 14th July 2020, covering the period to 30th June 2020 and further orders in the second half to 30th September -
"The over-performance, in terms of adjusted EBITDA1 growth, is largely due to high demand for the PrimeStore MTM Device which is used for safe COVID-19 sample collection and is manufactured under contract by EKF in the US and UK."

"largely" would appear to imply, that other areas/products are also performing (other areas may of course be under-performing). The main thrust here is two fold, there are Covid related tailwinds (and headwinds), and diseases like diabetes and haemoglobin testing that EKF are particularly exposed to cannot go untreated or not monitored regularly etc.

For instance, since the initial COVID-19 outbreak in China, much attention has focused on people with diabetes because of poor prognosis in those with the infection. Initial reports were mainly on people with type 2 diabetes, although recent surveys have shown that individuals with type 1 diabetes are also at risk of severe COVID-19. Diabetic ketoacidosis can be a big problem in individuals with diabetes, but I note the evidence of hyperglycaemia at hospital admission for in individuals with Covid-19 but with an unknown history of diabetes, and potentially new-onset diabetes another COVID related phenomenon.

COVID-19 in people with diabetes: understanding the reasons for worse outcomes
Published:July 17, 2020 -



Considering the above and indeed more, a perhaps important and timely addition to EKF's Diabetes Care portfolio back in March was the launch of a new FDA CLIA-waived β-ketone and glucose POC analyzer into the U.S. market that reliably and efficiently delivers results within just 5-10 seconds, which would surely be very useful in many healthcare settings, including hospitals -
- hxxps://www.ekfdiagnostics.com/fda-clia-waived-ketone-and-glucose-analyzer.html

This is only one example from EKF's point of care portfolio. But I also think EKF's Life Science division is also set (or already experiencing) for further increases in business/opportunity. I thus look forward to next month when we should get more context in all of this regard.

[marvelman] 10/8/2020 09:36

I assume it wasn't Brighton then Rivaldo :-)).......Yes, a great thread this and a rock solid company to have a stake in.

[rivaldo] 10/8/2020 09:26

Just back from hols, and great to see the excellent news flow continue, with the share price responding nicely.

Great research from wan et al, for which thanks from me too.

Incidentally, EKF were covered in this month's August issue of Techinvest (prior to the recent £3m contract news), covering the usual ground and strong investment case, and concluding "Continue to buy".

[mirandaj] 09/8/2020 11:38

Thank you wan and hastings for your informative and very helpful posts.

I find all the company's subsidiaries interesting, even the dormant ones.

See Note 19. (Page 57)

EKF Diagnostics Limited (UK)* 1 100% Ordinary Head Office

Quotient Diagnostics Limited* 1 100% Ordinary Sale of diagnostic equipment

360 Genomics Limited* 1 100% (indirect) Ordinary Sale of diagnostic equipment

EKF Molecular Diagnostics Limited* 1 100% Ordinary Manufacture and sale of diagnostic equipment

DiaSpect Medical AB 2 100% Ordinary Head office and IP licencing

DiaSpect Medical GmbH 3 100% (Indirect) Ordinary Manufacture and sale of diagnostic equipment and consumables

EKF-diagnostic GmbH 3 100% Ordinary Manufacture and sale of diagnostic equipment and consumables

Senslab GmbH 3 100% (indirect) Ordinary Manufacture and sale of diagnostic equipment and consumables

EKF Diagnostyka Sp.z.o.o. 4 100% (indirect) Ordinary Manufacture and sale of diagnostic equipment and consumables

000 EKF Diagnostika 5 60% (indirect) Ordinary Sale of diagnostic equipment

EKF Diagnostics Inc 6 100% Ordinary Intermediate holding company

Stanbio Laboratory LP 6 100% (indirect) Partnership Manufacture and sale of diagnostic equipment and consumables

Separation Technology, Inc 6 100% (indirect) Ordinary Manufacture and sale of diagnostic equipment and consumables

EKF Diagnostics Limited (Ireland) 7 100% Ordinary Manufacture and sale of diagnostic equipment

1261 N Main LP 6 100% (indirect) Partnership Dormant
Stanlab Management LLC 6 100% (indirect) Ordinary Dormant
1261 N Main Management LLC 6 100% (indirect) Ordinary Dormant
EKF POC, LLC 6 100% (indirect) Ordinary Dormant
Argutus Intellectual Property Limited 7 100% (indirect) Ordinary Dormant
EKF Diagnostics (Shanghai) Co. Ltd 8 100% Ordinary Dormant

[hastings] 09/8/2020 10:17

Agreed, the Interim results should prove interesting.

[cravencottage] 09/8/2020 09:31

These are exciting times.

Exponential growth seems inevitable.

[wan] 09/8/2020 07:26

Without wanting to dilute what has already been posted, or arouse any over-excitement surrounding PrimeStore MTM. I thought the following UK specific news from the Department of Health & Social Care regarding a recall that's specific to a certain COVID-19 sample collection kit is worthy of note -

Update on Randox test kits
Notification of issue relating to test kits produced by Randox laboratories. This affects the ‘Randox COVID-19 Home Testing Kit’ with the catalogue number: EV4429.

Published 7 August 2020
Last updated 8 August 2020

The Medicines and Healthcare products Regulatory Agency has instructed Randox to recall the ‘Randox COVID-19 Home Testing Kit’ with the Catalogue Number: EV4429 from NHS Test and Trace testing settings.

This decision has been taken as a precautionary measure to prevent any further use of these Randox tests. Anyone who is in possession of this Randox test kit should follow the below instructions on how to return kits to Randox.

Action to be taken:

discontinue use of and quarantine any stock of the Randox COVID-19 Home Testing Kit immediately

follow the instructions listed below to ensure the return of any stock of the Randox COVID-19 Home Testing Kit to Randox Laboratories Limited:

For the Care Home Channel: making use of the original shipping carton or the return boxes that were provided to Care Homes, package all remaining COVID-19 Home Testing kits into these boxes. If no suitable packaging is available, packaging may be requested (details to follow). A return label will be provided and must be affixed in a prominent position to the outer package for return to Randox Laboratories Limited. A courier will collect the unused kits within a specified time period, different to that for the collection of staff and resident samples that are being processed for COVID-19 testing.

For kits at a Warehouse facility: Randox will arrange for collection and transport of this stock to Randox Laboratories Limited. The Warehouse facility will be requested to advise on the number of cartons to be collected.

For the at Home Channel: a return postage paid envelope is included in the Randox COVID-19 Home Testing kit. Therefore, the kit should be opened and the contents repackaged in the return envelope and the return postage label affixed. The label will direct the kit to the Royal Mail Collection Centre in Northern Ireland. Randox will take receipt of these deliveries.

On July 15 NHS Test and Trace were notified that some test kits produced by Randox laboratories may not meet our required safety standards for coronavirus testing. Alongside the Lighthouse Laboratories, NHS Test and Trace has a separate contractual arrangement with Randox laboratories. As a precautionary measure and while we investigate further, NHS Test and Trace paused the use of these Randox test kits with immediate effect.

The risk to safety is low and test results from Randox kits are not affected.

We have been supporting all testing settings to receive replacement kits as soon as possible.



Randox were obviously made aware of the situation on the 15th July -

STATEMENT FROM RANDOX: 07 August 2020

Randox Laboratories have today taken the decision to recall Covid-19 sample collection kits, following the identification of incomplete EC certification. On 15th July DHSC placed these kits on hold due to the absence of swab certification from an external supplier. To date, Randox have not been provided with evidence to satisfactorily support the CE marking for these swabs. So, noting the lack of CE certification by the supplier and that some kits remain in the field at this time Randox has, as a regulatory measure, initiated the recall of those kits used within the National Testing Programme.

Randox Laboratories will continue to provide high volume Covid-19 testing to the National Testing Programme from their laboratories, based on sample collection kits from other providers.

DHSC have stated the risk to safety is low and test results from Randox kits are not affected.

This recall applies only to sample collection kits within the UK National Test and Trace Programme. Randox private customers or kits are not affected.


PrimeStore MTM is both FDA cleared and CE marked -

Key features -
Test for multiple viruses from one sample swab
Unique design
No cold chain required
FDA Class 2 cleared and CE marked
For use with COVID-19, flu A, flu B, HIV, TB and more


The following details are relatively new -

PrimeStore® MTM
Ensuring safe collection and
transportation of pathogenic samples


PrimeStore MTM
FREQUENTLY ASKED QUESTIONS


The above Randox recall, and from Hastings excellent CEO interview - "The UK is also now ramping up Baines adds which has been assisted by a recent report from Public Health England that recommends PrimeStore as being the safest device for transportation." Perhaps brings into sharp relief the attributes of using EKF's PrimeStore MTM, which in turn may catalyse further enquiries from 'new partners' from the private sector to use PrimeStore MTM for UK testing, and indeed testing in Europe.

[cravencottage] 08/8/2020 11:08

Great Post Wan

[9degrees] 08/8/2020 11:06

hear hear marvelman
thanks wan have been with you here for years and your research is invaluable

[marvelman] 08/8/2020 10:08

Wan...a huge amount of research and knowledge about this company which you are kind enough to share with others. Greatly appreciate your work. This is the largest individual investment I have ever had in any company and by investment I mean exactly that. Your posts are incredible....many thanks.

[wan] 08/8/2020 08:29

And obviously we need to factor in the following, which is in addition to the $14.1m -

New partner from the private sector to use PrimeStore MTM for UK staff testing

EKF Diagnostics Holdings plc (AIM: EKF), the AIM listed point-of-care business, announces that it has received an initial order worth £3m from a partner from the private sector to supply PrimeStore MTM, a novel patented sample collection device, to be used in a COVID-19 testing programme for UK staff. This new supply contract is in addition to the $14.1m orders for the three-month period ending 30 September 2020, already disclosed in the 14 July 2020 update, and also covers the period ending 30 September 2020.

[wan] 08/8/2020 08:18

Into the mix we must factor in the recent Trading Update for the first half of 2020, not to mention that the Board expects the second half of the year to see continued momentum, demonstrating that cash generation is continuing to accelerate, with some believing that cash flow is a more important factor/indicator than accounting profits -

Trading update

The current financial year has started very well, as reflected in the recent trading updates and upgraded market expectations. The over-performance, in terms of adjusted EBITDA1 growth, is largely due to high demand for the PrimeStore MTM Device which is used for safe COVID-19 sample collection and is manufactured under contract by EKF in the US and UK.

Previous guidance from the 15 May 2020 trading update set expectations of revenues of at least £25m and adjusted EBITDA £7.5m for the first half, and these have been comfortably exceeded. Revenues for the six months ended 30 June 2020 are £26.3m (H1 2019: £21.44m) and the Company expects to report adjusted EBITDA in the region of £9m (H1 2019: £5.58m).

Gross cash as at 30 June 2020 was £16.9m and cash net of borrowings was £16.3m, significantly above management expectations. The Company’s Renalytix AI plc securities (2,677,981 shares) are valued at a fair value of £14.2m, based on the closing mid-market price on 30 June 2020.

Earlier this year, EKF shareholders approved a payment of an inaugural dividend reflecting the progress in the business and its strong cash generation. A dividend of 1p per share will be paid on 1 December 2020 to shareholders on the register on 6 November 2020.

Further orders for PrimeStore MTM sample collection devices and Outlook

The Board expects the second half of the year to continue this momentum and announces that it has received second half orders worth a total of $14.1m from Longhorn Vaccines and Diagnostics LLC ("Longhorn") in the US, for their FDA-approved PrimeStore MTM sample collection device, which deactivates viruses, bacteria, fungi and mycobacterium tuberculosis and allows safe sample handling and transport, greatly reducing risk of infection. The orders cover the three-month period of July, August and September.

[wan] 08/8/2020 08:03

Some of us have been invested in EKF for a very long time and are very aware that there is so much more to EKF than just the current excitement and growth associated with PrimeStore MTM, and thus much more which provides for long term sustainable revenues and growth.

New readers/investors might be less aware that a few years ago EKF was restructured and refocused on profitability and organic sales growth. The effects of which started to show from 2016 onward, followed by eps starting to 'emerge' from 2017, but with cash generation on relatively steep trajectory -

2016
Financial Highlights
• Revenue up 28% to £38.6m (2015: £30.0m)
• Gross profit up 24% to £18.3m (2015: £14.7m)
• Adjusted EBITDA* of £6.1m (2015: loss of £0.3m)
• Cash generated from operations of £8.8m (2015: £2.9m used)
• Cash at 31 December 2016 of £7.9m (31 Dec 2015: £2.0m), Net cash of £2.2m (31 Dec 2015: £8.8m Net debt)
* Excluding exceptional items and share based payments

2017
Financial Highlights
• Revenue up 8% to £41.6m (2016: £38.6m)
• Gross profit up 25% to £22.9m (2016: £18.3m)
• Adjusted EBITDA* up 52% to £9.3m (2016: £6.1m)
• Earnings per share of 0.59p (2016: nil)
• Cash generated from operations of £10.1m (2016: £8.8m)
• Cash at 31 December 2017 of £8.2m (31 Dec 2016: £7.9m), net cash of £7.0m (31 Dec 2016: £2.2m)
• Capital restructure creates distributable reserves and allows share buy back programme
* Excluding exceptional items and share based payments

2018
Financial Highlights
• Revenue up 2% to £42.5m (2017: £41.6m)
• Gross profit broadly flat at £22.7m (2017: £22.9m)
• Adjusted EBITDA* up 15% to £10.7m (2017: £9.3m)
• Profit before tax £12.2m (2017: £4.3m), over 2.8 times higher
• Basic Earnings per share of 2.21p (2017: 0.59p), underlying basic earnings (excluding exceptional items and share
based payments) of 1.01p (2017: 0.58p)
• Cash generated from operations of £9.9m (2017: £10.1m)
• Cash at 31 December 2018 of £10.3m (31 Dec 2017: £8.2m), net cash of £9.4m (31 Dec 2017: £7.0m)
* Excluding exceptional items and share based payments

2019
Financial Highlights
• Revenue up 6% to £44.9m (2018: £42.5m)
• Gross profit up 4% to £23.7m (2018: £22.7m)
• Adjusted EBITDA* up 12% to £12.0m (2018: £10.7m)
• Profit before tax £5.5m (2018: £12.2m; £5.8m excluding exceptional gain from Renalytix AI plc spin-out)
• Basic Earnings per share of 0.81p (2018: 2.21p), underlying Basic Earnings per share* of 1.20p (2018: 1.01p)
• Cash generated from operations of £6.5m (2018: £9.9m)
• Cash at 31 December 2019 of £12.1m (2018: £10.3m), net cash of £11.4m (2018: £9.4m)
• Maiden dividend preserved and payable to shareholders on 1 December 2020
* Excluding exceptional items and share based payments


So, it's early days, and the metrics should continue to improve.

Looking beyond the financial metrics, how does one value the agreement and relationship with Mount Sinai? This agreement and relationship provides EKF with advanced access to innovative commercial opportunities and presents significant opportunity for EKF to collaborate on ground breaking medical technologies that can be spun off and proceed down the IPO route.

This has already resulted in shareholders benefiting from owning shares via a dividend in specie in the spin off, Renalytix, currently valued at over £6 per share.

If you were only focused on certain financial metrics such ROE etc, then you wouldn't have been invested here to have benefited from what is arguably difficult to measure, but a track record in terms of delivery is encouraging to say the least!

[cravencottage] 07/8/2020 22:18

All the new conracts will fall down to the bottom line..

Momentum is (unfortunately) with ETF given the current climate..

Re-rating just begun imo

As always dyor

[james188] 07/8/2020 17:57

Just to change the focus slightly, has anyone else wondered why the ROE/ROTIC figures for EKF are very low for a growth stock, especially as EKF has stated that it is not a capital intensive business?

The figures should improve given recent order/associate cash generation and likely future orders, but on the other hand we don't know how much EKF has had to invest this year to gear up very significantly in a short space of time.

There is a lot to like about EKF (and not just the PrimeStore MTM business), but it is not (yet) hugely profitable.Hopefully that will soon change.

[wan] 07/8/2020 08:23

Longhorn (and EKF) are ready to help meet the increased capacity efforts -

New SARS-CoV-2 Study: Pooling samples collected in PrimeStore MTM

is ideal for testing large populations such as employees and students with a significant reduction in infrastructure and cost. Pooling samples requires small amounts of each sample to be combined into a new tube, PrimeStore MTM allows the process to occur on the bench top. Samples in VTM/Saline are still considered infectious and must be transferred in a biological safety cabinet, significantly slowing down the work flow.

​
Longhorn will provide 50 tube preform racks to laboratories that receive PrimeStore MTM in preform tubes from FEMA allocations.

[cambridgedon] 07/8/2020 08:07

Great work Wan!
Thank you.
CD

[wan] 07/8/2020 08:02

To be clear, EKF's PrimeStore MTM was invented and optimised specifically for molecular testing, such as PCR testing.

[wan] 07/8/2020 07:58

The following puts PCR testing into perspective, and it is why countries, including the US, are focused on building increased PCR testing capacity -

As Covid spreads, ramping up RT-PCR testing capacity is crucial
August 6, 2020

The two most important tools in this fight continue to be masks and tests. Encouraging and ensuring proper use of the first lies well within state capacities, and here it is the state and local administrations which must deliver. But on testing, especially RT-PCR testing which is the gold standard of Covid diagnosis, lab capacities need serious shoring up in many parts of the country. This must be done with central support.

The quicker antigen testing has a role but it is no substitute for RT-PCR testing. As ICMR director-general Dr Balram Bhargava said on Tuesday, initially rapid antigen tests comprised only 5-6% of the total tests conducted in a day but now we have many states like Uttar Pradesh overwhelmingly relying on RATs. But as these tests can miss a seriously large number of asymptomatic cases, depending on them alone cannot help us curb virus transmission. Building infrastructure for RT-PCR tests may be tough. But there’s no running away from it.

Full story -

Jul 31, 2020
National Labs Focused on Building PCR SARS-CoV-2 Test Capacity in Anticipation of Fall

Lab firms are acquiring equipment and implementing approaches like pooled testing, but it remains unclear if this will be enough to meet a fall surge.

[wan] 07/8/2020 07:46

6th August 2020

Trump orders agencies to purchase U.S. made drugs and medical supplies
Susan Morse, Managing Editor

President Donald Trump on Thursday signed an executive order establishing a "buy American first" policy on the purchase of essential medicines, medical devices and their components and personal protective equipment.

The order requires U.S. agencies to purchase essential medicines and medical supplies from domestic sources, instead of from foreign countries such as China.

It will be up to the Food and Drug Administration to produce a list of critical supplies, including the essential drugs.

"The United States must protect our citizens, critical infrastructure, military forces, and economy against outbreaks of emerging infectious diseases and chemical, biological, radiological, and nuclear (CBRN) threats," the order states. "To achieve this, the United States must have a strong Public Health Industrial Base with resilient domestic supply chains for Essential Medicines, Medical Countermeasures, and Critical Inputs deemed necessary for the United States."

This includes threats from emerging infectious diseases such as COVID-19.

Trump directs each executive department and agency involved in the procurement of essential medicines and medical supplies outlined in the order to consider a variety of actions to increase their domestic procurement and to identify vulnerabilities in the nation's supply chain.

WHY THIS MATTERS

The order is aimed at reducing U.S. dependence on foreign manufacturers in light of the scarcity of domestic supplies and reliance on imports during COVID-19.

Navarro also said the requirement would help establish demand for investment in the manufacturing process, according to The Wall Street Journal.

THE LARGER TREND

The order accelerates the development of cost-effective and efficient domestic production of essential medicines and medical countermeasures so as to have an adequate redundancy built into the domestic supply chain, the order states.

It is the latest in a series of moves by the Trump administration to boost domestic production. During the pandemic, Trump invoked the Defense Production Act to compel American companies to produce medical supplies and equipment.

Full story -

Another tail wind in 2021 for EKF's 'expanded' and growing US manufacturing facilities, and not least, agency preparedness for the next pandemic.