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Detecting Covid-19 and proprietary material April 5, 2020

Posted by Tomboktu in Uncategorized.
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At the daily press conference by the Department of Health on Tuesday last (31 March) the question of the backlog of tests for the virus that causes Covid-19 disease was raised by a journalist. Dr Colm Henry, the Chief Clinical Officer at the HSE, gave the first answer in which he explained that there is a shortage of reagents everywhere and that the problem is not unique to Ireland.

Dr Cillian De Gascun, Director of the National Virus Reference Laboratory, then spoke. He said the following:

There are a couple of different components that we’re talking about. One that has been mentioned is lysis buffer. That’s an initial step to inactivate the virus. That can be made by pretty much anyone. So, we’ve engaged with colleagues in academia in Ireland to address that issue, so that’s no longer the immediate pinch-point for us.

The second issue is extraction material to actually extract the viral RNA, and that is proprietary, unfortunately. Maybe if we had a number of months it might be possible to develop an alternative extraction method, but at this point in time there is a certain amount of proprietary material that we need in the NVRL [National Virus Reference Laboratory] and the hospitals need to enable us to carry out the work on our existing platforms.

He made these comments between 22 min 19 sec and 23 min in the video the Department of Health published on Twitter (linked below).

I would like to see a journalist probe the precise why the proprietary material is causing a backlog. Are the owners of the proprietary material training national health authorities around the world but this takes time? Or have the owners of the proprietary rights not released the information needed for national health authorities to make the material?

 

 

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1. CL - April 5, 2020

“Pharmaceutical companies based in Ireland could soon be making the materials needed for processing Covid-19 tests, the head of IDA Ireland has revealed
There is such a shortage of a reagent we need that it has led to delays in getting results for tests here and around the world.
As a result, the HSE has now even started outsourcing test analysis to a foreign laboratory.
But Martin Shanahan, head of the foreign inward investment agency IDA Ireland, says pharma firms based here are in negotiations with the State to start making the reagents we are short of here.
He was asked by RTE if they are already making it and exporting it out of the country and replied: “I’m not sure about the extent to which they are manufacturing it.”
Asked if he knew if they could supply us with the amount of reagent we need, he said: “That is my expectation.”
He could not, however, say when they would start supplying us…..

And MyCorkGP.ie partner Dr Nick Flynn has questioned why the health service can’t just import supplies of the re-agent we need to carry out more tests.”
https://www.irishexaminer.com/breakingnews/ireland/ida-head-irish-pharma-firms-can-make-covid-19-testing-materials-991836.html

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CL - April 5, 2020

“Speaking to RTÉ’s Sean O’Rourke this morning, HSE CEO Paul Reid said Ireland is in a “chase around the world” with other countries to access supplies of reagents.
He said three actions have now been taken to address the supply issues. For now, some testing will be processed abroad to address the current backlog and allow labs to prioritise groups such as healthcare workers and hospital inpatients.
Reid said the HSE has also secured some supplies from China, but he said they will not be able to “fully validate” these reagents until they arrive next week.
He said he is also working with pharma companies and laboratories in Ireland to see if they can “significantly ramp up” their capacity to provide further supplies. Those discussions are continuing today.”
https://www.thejournal.ie/reagents-testing-pharma-5064565-Apr2020/

“US President Donald Trump has said Ireland is “a very tremendous producer” when it comes to US pharmaceutical companies based in Ireland….
According to IDA Ireland, 50% of ventilators used in acute hospitals worldwide are made in Ireland.
Exports of medical devices and diagnostic products represent 8% of Ireland’s total merchandise exports.”
https://www.rte.ie/news/2020/0318/1123803-us-coronavirus/

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2. Joe - April 5, 2020

“And MyCorkGP.ie partner Dr Nick Flynn has questioned why the health service can’t just import supplies of the re-agent we need to carry out more tests.”
Sounds like a really bright spark, this Dr Flynn.

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3. Tomboktu - April 6, 2020

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4. FergusD - April 6, 2020

You can do RNA extraction with simple lab chemicals, but it would be a bit lengthy. I suppose the issue is ‘kits’ that enable rapid and simple extraction and which are ‘proprietary’. Although the components of such kits may not be proprietary in themselves so i would have thought it would be possible to make them. It would take some time to do that though.

Back in the day, before kits, some of used to do this kind of stuff in research labs from fairly readily obtainable research reagents.

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CL - April 6, 2020

“Ireland’s pharmaceutical industry has indicated it is gearing up to produce key ingredients for Covid-19 testing which the State is struggling to source on the international market.
The industry could produce enough reagent – a key laboratory ingredient which is in short supply – to enable around 500,000 tests to take place, said Matt Moran, director of the pharmaceutical industry lobby group BioPharmaChem Ireland.”
https://www.irishtimes.com/news/ireland/irish-news/ireland-s-pharma-industry-gears-up-to-make-key-ingredient-for-covid-19-testing-1.4218334

So what progress is Irish pharma making in producing the necessary ingredient?
An update from Mr. Moran would be useful.
Having extensive testing, tracing, and isolation would allow a safe easing of the lockdown.

“Iceland, an island country home to about 364,000 people, has taken a different approach to the coronavirus than many other countries.
The government allows testing for anyone who wants it. Iceland is also working to identify people who have the virus quickly so it can isolate them.
The country has not gone on lockdown during the pandemic…

In order to expand its testing abilities, Iceland’s government teamed up with Reykjavik-based deCODE Genetics, which is a subsidiary of the US-based biotechnology company Amgen.”
https://www.businessinsider.com/iceland-coronavirus-pandemic-approach-could-help-other-countries-2020-4

“Amgen Dun Laoghaire (ADL) is a 37,000-square-metre aseptic operations facility….The ADL site also includes a bioprocessing suite and laboratories.”
https://careers.amgen.com/ireland

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tafkaGW - April 6, 2020

Indeed Fergal, listening to the virologists talk about it it’s how you organise many hundreds of tests to run simultaneously in as automated a way as possible. I think this involves buying machinery.

It may be that Ireland is suffering from the patents encumbering some of the machinery? Because AFAIK the test protocol is public domain.

Fuck all privatised medical technology patenting, it should public domain as a matter of course.

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Tomboktu - April 7, 2020

I’d like to see the HSE explain *all* of the technical and market difficulties in detail, and not summarise with headline points which leave others to speculate upon.

(This reminds me of the reporting of the bugging of the GSOC offices. Mefia reporting on the fact that some of the technology was not widely available and not of a type used in Ireland was abruptly dropped for the line that the detector picked up spurious signals from the internet cafe in the Spar on the ground floor.)

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tafkaGW - April 6, 2020

Reagent shortage for the qPCR tests is an issue here in Germany as well.

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