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vivoPHIX™ RNA stabilisation and virus inactivation collection reagent and tube

D3: Catalogue of Resources

RNAssist is a Cambridge, UK based technology development company focused on RNA stabilisation, pathogen inactivation and cell fixation, our lead product vivoPHIX™ has been evaluated by 240 researchers including at the University of Cambridge and Oxford, NIBSC, Pasteur, Sanger, CDC and MIT. 

Offer; A sample collection tube for swabs or saliva, containing vivoPHIX™ virus inactivation and viral RNA stabilisation reagent. 

Have you validated this method, if so, how and what were the results of the validation?

(1) vivoPHIX™ Inactivation: The vivoPHIX™ reagent inactivates all tested viruses including Vaccinia, BVDV, FIV, Duck HepB, Dengue and Influenza A (CDC, Pasteur Institute, and BluTest Ltd) and on this basis it should equally inactivate SARS-CoV-2. In addition, vivoPHIX™ has been shown to inactivate Staphylococcus aureus, Pseudomonas aeruginosa and Listeria, and knocks-down Candida albicans by 3-logs. Has been used to inactivate a Cat. 3 virus (Dengue) allowing handling in a Cat. 2 lab, as well as a Cat. 2 virus (Influenza A H1N1) for shipping (Pasteur Institute).

(2) vivoPHIX™ Stabilisation: Preliminary data demonstrates that vivoPHIX™ stabilises SARS-CoV-2 RNA in virus spiked sputum and is directly compatible with QIAamp Virus RNA purification and CV E-Gene RT-qPCR. Additionally vivoPHIX™ stabilises RNA, DNA and proteins, as one example; 12 month room-temperature liquid stabilisation of 2 strains of HCV in plasma has been achieved with vivoPHIX™ as determined by RT-qPCR and shown to be generally equivalent to -80°C storage. 
 
(3) vivoPHIX™ is directly compatible with front-end nucleic acid purification platforms including RNeasy, QIAamp™, QIAsymphony, QIAcube, Nuclisens, GeneXpertand Filmarray
 
UPDATE-1: vivoPHIX has been successfully tested with SARS-CoV-2 at log2, log3 and log4 concentrations by a UK Lighthouse lab.
 
UPDATE-2: vivoPHIX has been successfully demonstrated to inactivate SARS-CoV-2 (preliminary results)

How quickly could this be deployed and what are the dependencies?

A one day batch production of vivoPHIX™ has been validated, UK based supply of raw materials, manufacturing and vial filling facilities.

What is the likely production volume?

100 L/day

What are the risks and barriers to using this at scale?

vivoPHIX™ is non-toxic and non-volatile, it is a novel composition and does not contain any reagent (such as guanidine) that is currently used for SARS-CoV-2 RNA purification, therefore there is no direct competition for scarce materials and no known shortages of the raw materials. No known batch effects to volume scale up.

Who are you already partnering with on this?

Rapid Labs Ltd. UK

QCMD/Qnostics Ltd. UK

edited on Jul 1, 2020 by Andrew Goldsborough
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Bev Matthews Apr 21, 2020

The idea has been progressed to the next milestone.

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Bev Matthews Apr 21, 2020

Status label added: C

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Bev Matthews Apr 21, 2020

Hello Andrew, thank you for your submission, our team is currently reviewing your solution.

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Bev Matthews Apr 22, 2020

Hello Andrew, you solution is being reviewed. Could you respond to the following please:

When is manufacture date and at what scale initially please?

Look forward to hearing from you

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Andrew Goldsborough Apr 23, 2020

Hello Bev, thanks for your interest in vivoPHIX™ and getting back to us. I apologise for the slight delay in responding but I first wanted to discuss your important questions with our bulk manufacturer Rapid Labs (Essex, UK). We can start manufacturing within 1 week; bulk chemicals, filters and vials are all in stock, dispensing equipment installed and a new manufacturing clean room fitted last month.

We can initially manufacture 15,000 vials a day and this could be scaled up to 100,000 vials a day within 2 weeks. We look forward to any further questions you may have.

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Bev Matthews Apr 25, 2020

Thank you Andrew. this will be reviewed again this weekend

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Bev Matthews Apr 25, 2020

Thanks for this...are you OK if we pass on your details so that they can get in touch direct? Or provide a sales/contact person?

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Andrew Goldsborough Apr 25, 2020

Hi Bev, thanks again for your messages. Yes of course I would be delighted to be put in touch, could you please just let me know who will contact me (e.g. your colleagues at the Department of Health of other) so I can bring together relevant information in advance? Many thanks, Andy

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Andrew Goldsborough Apr 25, 2020

I just wanted to flag up in case they were missed, that I added 2 important files yesterday showing 33 day stabilisation data for SARS-CoV-2 and one other virus with vivoPHIX. I am concerned that they may have been missed in the thread. Thanks a lot for all your work. Andy

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Andrew Goldsborough May 1, 2020

Hi Bev, do you require any further information from us at this point? Any status updates would be appreciated. Thank you.

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Andrew Goldsborough Apr 24, 2020

As further strong support for the virus stabilisation properties of vivoPHIX, please see the attached 33-day room-temperature storage of SARS-CoV-2 and West Nile Virus in sputum, with and without added vivoPHIX. I would be pleased to answer any questions.

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Bev Matthews May 3, 2020

Thank you Andrew, the additional information provided is being reviewed. Bev

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Alexander James Phillips May 3, 2020

This data is really interesting Andrew. Do the team have any idea why the stabilisation also improves the sensitivity? On day 0 if it was just contributing stabilisation then you'd expect the Ct to be the same but it's actually (significant?) lower... Is this also acting like a mucolytic perhaps? Post here: https://testingmethods.crowdicity.com/post/3193060
Or perhaps it's something else. Perhaps it's positively effecting salt balance or pH.

Finally do you know if this is an open-source reagent composition?

Thank you!
AJP

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Andrew Goldsborough May 4, 2020

Hi Alexander, thanks for your pertinent question. All viral aliquots used in this assay were taken from the same master-mix to reduce technical variation, so you are perfectly correct that the Time point 0 Ct's (+/-) vivoPHIX should be identical. The lower Ct's in the presence of vivoPHIX could be for a number of reasons as you have already suggested including; (i) better SARS-CoV-2 and WNV RNA yields when combined with QIAamp®-MinElute® Virus Spin Kit (perhaps from a mucolytic effect you mention - tx for your post); (ii) better RNA template activity; and/or (iii) fewer contaminants in the eluted RNA. Although the precise reason for the lower vivoPHIX Ct's would be simple to ascertain, we haven't carried out such tests but my best guess would simply be better RNA yields.

For the last 3 years we have managed a 250 evaluator open innovation community including at the Sanger and Pasteur Institutes, CDC, MIT, NIBSC, PHE and the University of Cambridge and Oxford. Whilst vivoPHIX is not open-source, we can provide evaluation samples at no cost from our UK supplier and distributor. Please let me know. Andy A.Goldsborough@RNAssist.com

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Andrew Goldsborough May 6, 2020

Manufacturing update; second batch of 100 SARS-CoV-2 Sample Collection Tubes incorporating RNAssist technology, manufactured and shipped out today by Rapid Labs UK.

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Bev Matthews Jun 4, 2020

Hello Andrew, our champions have asked for data that confirms your solution inactivates SARS-COV2 please. Thanks Bev

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Tom Jordan Jun 25, 2020

Hi Andrew, we'd be very grateful to hear from you on this solution and update our expert reviewers. If you can provide this information, we'd be keen to share this with labs as a resource. Look forward to hearing from you. Kind regards, Tom

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Andrew Goldsborough Jun 25, 2020

Hi Tom, thanks for your message, I completely understand that you require inactivation data for our reagent. Although all 8 tested viruses are inactivated by vivoPHIX (HepB, Vaccinia, FIV, BVDV, Rift Valley Virus, Dengue, Zika and Influenza A) it has been a significant challenge, despite contacting 9 different institutes and companies, to find any that can test our reagent with SARS-CoV-2. If you have any suggestions they would be greatly appreciated.

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Andrew Goldsborough Jun 25, 2020

UPDATE: vivoPHIX has been successfully tested with SARS-CoV-2 at log2, log3 and log4 concentrations by a UK Lighthouse lab.

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Bev Matthews Jun 4, 2020

Status label added: More information requested

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Tom Jordan Jun 25, 2020

Status label added: B: One to watch

Status label removed: C: Further assessment

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Andrew Goldsborough Jul 1, 2020

UPDATE: vivoPHIX has been successfully demonstrated to inactivate SARS-CoV-2 (preliminary results)

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Tom Jordan Jul 9, 2020

Thanks Andrew, for this submission too the reviewers have seen the extra information you provided today and are keen to make this a resource for labs to consider.

Kind regards,
Tom

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Tom Jordan Jul 9, 2020

Status label added: D3: Catalogue of Resources

Status labels removed: B: One to watch, Additional information

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