Skip to Main Content
Page banner

Submitted
Being Assessed
Responded
Thanks for your vote
This voting milestone has now ended, and the idea has progressed to a private milestone
Return to idea list
Thanks for approving the idea
This milestone has now ended, and the idea has progressed to a private milestone
Return to idea list

PrimeStore MTM

E: A connection is helpful

PrimeStore® MTM's pathogen inactivation and nucleic acid stabilization characteristics make it the ideal solution for transporting samples that potentially contain dangerous infectious agents for molecular testing and Next Generation Sequencing.

PrimeStore® MTM is optimized to inactivate/kill infectious biological pathogens, including influenza, mycobacterium tuberculosis, gram positive/negative bacteria, and viruses.  It disrupts/lyses lipid membranes and inactivates nucleases.  PrimeStore® MTM preserves and stabilizes RNA and DNA at ambient temperature and is compatible with manual and high throughput RNA/DNA isolation kits.  PrimeStore® MTM eliminates cold chain costs for shipping and initial testing. Samples in PrimeStore® MTM can be frozen for multi-year storage and are not degraded by multiple freeze/thaw cycles.

Warning (from CDRH website) - Do not use PrimeStore MTM with the Hologic Panther or Panther Fusion Systems due to a disinfecting step involving bleach that is specific to the platform. When the bleach interacts with the guanidine thiocyanate in the transport media, it produces dangerous cyanide gas. 

 

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

PrimeStore MTM received clearance from US FDA (DEN170029).

Published studies have demonstrated PrimeStore MTM's capabilities for collecting, transporting, and storage for molecular testing of a variety of sample types.

PrimeStore® MTM has been demonstrated to completely inactivate viruses, bacteria, and fungi. Multiple studies have demonstrated that PrimeStore® MTM reduces Bacillus spores by three to four logs. Samples suspected of containing spores should be treated as though viable spores remain.

 

 

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

 

PrimeStore MTM production is currently in the US, but production is planned within the UK by May.

What is the likely production volume?

12,500-25,000 tubes per day.

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

 

Warning (from CDRH website) - Do not use PrimeStore MTM with the Hologic Panther or Panther Fusion Systems due to a disinfecting step involving bleach that is specific to the platform. When the bleach interacts with the guanidine thiocyanate in the transport media, it produces dangerous cyanide gas. 

Who are you already partnering with on this?

Longhorn Vaccines and Diagnostics, the Legal Manufacturer for PrimeStore MTM.

You will need to login to post a comment

Sue Hill Apr 21, 2020

Has this been used in COVID 19 TESTING

Reply 0

Andrew Rutter Apr 21, 2020

Yes. So far, in excess of 1 million tubes of PrimeStore MTM has been used in COVID-19 detection in more than 20 countries. This includes 300,000 tubes delivered to New York State, with an order of the same quantity currently in production.

Reply 0

Bev Matthews Apr 21, 2020

Thank you Andrew. This additional information will be reviewed

Users tagged:

Reply 0

Bev Matthews Apr 26, 2020

Hi Andrew, can you confirm where this is in use please?

Reply 0

Andrew Rutter Apr 26, 2020

Bev,
Here is a list of countries/authorities/US testing centres where the PrimeStore MTM tubes have been used for COVID-19 testing -
International
• China (tested, registered and being sold)
• Dubai Health Authority
• Italy (government laboratories)
• Israel (tested by the Ministry of Health)
• Spain
• Thailand
• South Africa (to the government)
• Rwanda
• Brazil
• Panama
• Canada
• Belgium
• Portugal
• Germany

United States
• New York State Department of Homeland Security (tested and immediately ordered over one million tubes)
• State of Florida
• State of Illinois
• State of North Carolina
• State of Arizona
• Massachusetts
• Harvard University
• Vanderbilt University
• Stanford University
• US Military Hospital San Diego
• Many more Medical Schools, Hospitals, Clinics, Diagnostic Laboratories across the country
• A number of State Animal Health/Veterinary Laboratory have tested and inform us that they are being asked to assist the testing of human samples in their states

Best regards,
Andrew

Reply 0

Bev Matthews Apr 21, 2020

The idea has been progressed to the next milestone.

Reply 0

Bev Matthews Apr 21, 2020

Status label added: Requested more information

Reply 0

Bev Matthews Apr 25, 2020

Status label removed: Requires more information

Reply 0

Bev Matthews Apr 29, 2020

Status label added: E: For another team

Reply 0

Andrew Rutter Apr 29, 2020

Bev,
Please can you advise on the next steps. Which team will pick up on this? Is there anything I can do from our side?
Very best regards,
Andrew

Reply 0

Andrew Rutter May 5, 2020

Who should I reach out to in order to make the connection?
Best regards,
Andrew

Reply 0

Luke Wainwright May 29, 2020

Dear Andrew,

Many thanks for sharing the information above. Please refer to the 'supply materials and equipment' section on the following webpage:

https://www.gov.uk/guidance/help-the-governme...esting-capacity

Kind regards,
Luke

Reply 0

Andrew Rutter May 29, 2020

Dear Luke,
A submission has already been made via the gov.uk portal - on 11th May. The reference is NHS-181569-R7T2 CRM:0068597.
Kind regards,
Andrew

Reply 0

Luke Wainwright May 29, 2020

The idea has been progressed to the next milestone.

Reply 0

Share