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Large hospitals plead with researchers for stuff in their labs that could be used to create coronavirus test kits

Brigham and Women's Hospital and Mass. General have issued a plea to researchers who might have the instruments and components they would need to begin producing Covid-19 test kits:

As you know, there has been an ongoing challenge to clinically test patient samples for COVID-19 infection. In accordance with the recently released FDA guidance on Emergency Use Authorization for COVID-19 testing, clinical laboratories at Mass General Brigham are actively developing an assay to test patient samples.

To ensure these assays meet FDA requirements (under development), our clinical laboratories have to use specific kits, reagents, and equipment to perform urgent validation studies and subsequently test patient samples. Currently many of these items are either on back-order or do not exist for us to purchase.

The request says that once the things on the list become commercially available again, "we will replace them for you" and adds:

Thank you in advance for demonstrating firsthand how, when we come together as a system, we can fulfill critical needs to provide the best care to our patients and personnel.

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Comments

I'm not familiar with these reagents, but surely some of the other biotech companies have these things in their storage cabinets. I don't expect them to give up things that will force them to stop work, but if you've got a case of something, you could share a few bottles for this important public need.

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I saw a call for these reagents (RNA extraction kits) a few days ago, it went out to vendors on Science Exchange. I understand the shortage, but it didn't give me a great feeling.
These reagents are a basic lab staple, and easy to order in bulk. My uninformed guess is that this is another supply chain problem, with real world consequences.

For the nerdy among us, the kits are probably the garden variety you can find in any molecular lab, probably made by QIAGEN. Probably with buffers and a filter/spin column. The testing labs prize them because they're manufactured with rigor and very easy to use -- anything to reduce error.

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mj-research (waltham) fabricates centrifuges.
years ago, i worked thermo-dynamic (now thermo-fisher) and they have warehouses dedicated with brackets and wiring harnesses to make these things (i doubt those specific brands).

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Today a local company -- Marlboro base Hologic received FDA approval for its molecular diagnostic coronavirus test that can provide results in less than three hours.

Story is now out in the open on Herald Website -- excepts below with my highlights in bold
https://www.bostonherald.com/2020/03/17/marlborough-companys-coronavirus...

Coronavirus test developed by Marlboro-based Hologic receives FDA approval
By ALEXI COHAN | [email protected] | Boston Herald
PUBLISHED: March 17, 2020 at 12:36 p.m. | UPDATED: March 17, 2020 at 1:18 p.m.

We made this story available to all readers in the interest of public safety. Please consider supporting our coverage of the coronavirus by subscribing to The Boston Herald.

A Marlborough company got the green light from the FDA for its molecular diagnostic coronavirus test that can provide results in less than three hours.....

Hospital, public health and reference laboratories can perform the Hologic Inc. test on the company’s Panther Fusion system, which is a fully automated diagnostic platform used across the United States.

Each system works quickly and can process up to 1,150 coronavirus tests in a 24-hour period. It includes 16 FDA-cleared tests for various infectious diseases such as other respiratory viruses with symptoms that overlap with coronavirus....

Hologic was the first company to receive support for coronavirus test development from the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority.

“Making rapid and accurate diagnostic tools available to healthcare providers is critical for early detection and control of COVID-19,” said BARDA Director Rick Bright.

Hologic expects to provide its customers with tens of thousands of tests this month and starting next month, the company expects to produce nearly 600,000 tests a month.

The Hologic diagnostic test has not been cleared or approved by the FDA, it has been authorized for use by labs to perform tests.

The emergency use authorization authority allows FDA to help strengthen the nation’s public health protections by facilitating the availability and use of medical countermeaures needed during public health emergencies.

The key is to unlock the genius of our biomed industry by backing off on entangling Gov't red tape

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It has to be analysed using a proprietary system. Those may be in limited supply:

Hospital, public health and reference laboratories can perform the Hologic Inc. test on the company’s Panther Fusion system, which is a fully automated diagnostic platform used across the United States.

If you think that government red tape is somehow reduced by requiring a proprietary system be used, then I can't help you.

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which is a fully automated diagnostic platform used across the United States.

and you wrote

If you think that government red tape is somehow reduced by requiring a proprietary system be used, then I can't help you.

That is not a productive or useful comment -- you don't know how many of the Hologic platforms are in place, and you don't know how well they integrate into anything on a larger scale

The relevant point is Hologic, Thermo-Fisher and Roche have either got in shipping or on the loading docks testing systems capable of delivering thousands of tests per day and ramping-up.

And in the case of the Hologic -- not only is it high volume -- its fast. Finally we will be able to tell a patient, with about the same delay as for the Seasonal Flu, whether that is what they have -- and then how to take care of themselves.

Still in the pipeline are home-test kits where you can swab yourself and then have the sample evaluated rapidly. And even in the lab -- MIT has a paper test strip which can be read instantly like a home pregnancy test.

When this is over -- We need a Blue-ribbon panel to evaluate the lessons-learned and make recommendations for permanent not just emergency changes in the FDA's and other bureaucratic processes providing inertia against innovation.

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If there was no "entangling Gov't red tape" we'd probably have 50 different tests available by now....and 45 of them would be mostly inaccurate. There are rules that are stupid and stand in the way of progress, but the ones that make sure things are safe and that they work are just fine by me.

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We are already in a pandemic. no need to test, we should all assume we are carrying coronavirus. We should all avoid social gatherings and follow government guidelines. do you think they had RNA tests in previous epidemics.
also when this is over lets bring back those factories from china and start making the products we need here and scale them up fast when needed

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BIDMC is closing their research labs for awhile. All relevant supplies are likely being diverted to clinical areas

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