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Supply of Viral Molecular Transport Medium - safer, faster, no cold chain shipping.

D2

VH Bio Ltd, through our supply partner Longhorn Vaccines and Diagnostics, can make large quantities of their PrimeStore Molecular Transport Medium available to safely and effectively inactivate the virus to support UK testing.

https://www.vhbio.com/viral-molecular-transport-medium/

Longhorn Vaccines & Diagnostics (https://www.lhnvd.com/), based in Bethesda, Maryland, is an innovative molecular tool, assay and vaccine development company focused on serving unmet critical needs in both developed and developing nations. VH Bio Ltd (https://www.vhbio.com/) acts as a distributor for Longhorn Vaccines & Diagnostics in the UK. Longhorn’s core product, PrimeStore Molecular Transport Medium (MTM), is a patented, FDA-approved, state-of-the-art ambient temperature molecular diagnostic collection and transport device that can help governments, global health organisations and drug manufacturers improve the diagnosis and treatment of infectious diseases.

PrimeStore MTM is the first and only microbial nucleic acid storage and transport device cleared by the US Food and Drug Administration (US FDA). Unlike standard methods for collecting and transporting samples, PrimeStore MTM safely deactivates pathogens at the point of collection and stabilises RNA and DNA, allowing enhanced point of care and ambient temperature transport for laboratory-based molecular testing with no need for special containment facilities.

PrimeStore MTM alleviates the challenge of collecting a quality sample and transporting it in a safe and timely manner to any laboratory that can effectively test that sample using modern molecular platforms. PrimeStore MTM has multiple issued patents in the United States and worldwide.

VH Bio/Longhorn are working with buyers to optimise tube selection to match available swabs and to fit into existing automation systems.

In the US, Longhorn is supplying PrimeStore MTM to major labs and hospitals to support the nation's COVID-19 testing. The company is also being encouraged by the FDA to help solve the Coronavirus testing bottleneck by teaming PrimeStore MTM with diagnostic developers - see https://bit.ly/3e9XgLT 

Samples stabilised and inactivated in PrimeStore MTM can be biobanked for additional testing. The RNA will still be there and will not have degraded.

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

PrimeStore MTM is FDA-cleared. It is the only FDA-cleared Class II device for microbial inactivation and stabilisation for RNA and DNA. The product is on the FDA’s preferred Transport Media list.

Published papers on coronavirus transported in PrimeStore MTM:

Burden and Risk Factors for Coronavirus Infections in Infants in Rural Nepal

Aetiology of childhood pneumonia in a well vaccinated South African birth cohort: a nested case-control study of the Drakenstein Child Health Study

Microbiology of the Nasopharynx in Children Hospitalized with Suspected Pulmonary Tuberculosis 

Microbial Aetiology of Community Acquired Pneumonia at a Tertiary Hospital

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

The deployment will depend on tube availability when orders are placed and then the speed of airfreight from the US to the UK. 

New orders will currently be filled late April/early May, however, Longhorn is adding production capacity all the time. Any large, i.e. million tube-plus, order will need to be broken down into multiple weeks of production. 

Once VH Bio Ltd and Longhorn know the volume required, Longhorn could dedicate one facility or more to just tubing PrimeStore MTM to support UK testing.

Flexibility in tube size will shorten lead times. Obviously tube size is often determined by the breakpoint of the nasopharyngeal swab, however, 5mL, 4mL, 3mL and 2mL tube sizes are available for "tubing" PrimeStore MTM in.

Bulk 20L cubitainers of PrimeStore MTM can also be supplied to clients who have the ability to source their own tubes and fill and finish. If this option is required, VH Bio Ltd / Longhorn can start shipping bulk within a week.

What is the likely production volume?

Production volume will be aligned to demand.

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

The biggest issue of using PrimeStore MTM at scale will be tube availability. The quicker VH Bio Ltd / Longhorn can be made aware of order volume requirements, the shorter the lead time for delivery.

Longhorn is partnering with as many tube manufacturers as possible to try to minimise lead times.

Who are you already partnering with on this?

In the US, as the only FDA-cleared Class II device for microbial inactivation and stabilisation for RNA and DNA, PrimeStore MTM is already used by major labs and hospitals to support the nation's COVID-19 testing. Longhorn is also currently working with the US government to ramp up its production to meet the country's demand. The company is also being encouraged by the FDA to help solve the Coronavirus testing bottleneck by teaming PrimeStore MTM with diagnostic developers.

edited on Apr 16, 2020 by David Gokhale
James Briggs

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Kyle Beacham 9 months ago

Status label added: C

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Kyle Beacham 9 months ago

The idea has been progressed to the next milestone.

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James Briggs 9 months ago

When can we next expect to hear from the team, Kyle? We just want to make sure we are fully prepared for when that time does come. Thanks.

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Bev Matthews 7 months ago

Hello James, just a quite update that the assessors are continuing to consider the options and opportunities of your solution. We will be in touch again soon but do please share any new information you may have available. Many thanks Bev

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David Gokhale 9 months ago

There is a case for the use of this existing viral inactivation product to also be used for Sars-CoV-2 testing. I would still recommend that inactivation studies on Sars-CoV-2 itself are carried out but initially this could be to establish the minimum safe time to achieve inactivation. The laboratory receiving such samples would no doubt need evidence that the sample was safe or I assume would still insist on CL2+ containment. It would seem sensible that a pilot is carried out before widespread use.

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Tom Jordan 7 months ago

Thank you for sharing this submission on the platform. Following review by our champions, we have forwarded this to the central team looking at viral inactivation and this team will be in touch to work through any next steps.

Kind regards,
Tom Jordan

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Tom Jordan 7 months ago

Status label added: D2

Status label removed: C: Further assessment

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Tom Jordan 7 months ago

The idea has been progressed to the next milestone.

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