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Novel Blood Collection Device that Enables Small-Volume Capillary Blood Collection for Diagnostic Testing

A: Not for current challenges

BD would like to engage in exploratory discussions about a novel, easy to use blood collection device, that is currently in development. BD in partnership with Babson Diagnostics has developed a revolutionary capillary blood collection system that eliminates the challenges commonly faced with traditional capillary collection. It can be easily used for blood collection without phlebotomy training, and this device consistently and reliably provides a few hundreds of microliters of laboratory-quality capillary blood without the need to access a vein.  The high-quality sample collected will support a wide array of tests including rapid COVID-19 serology testing. Since the system is not yet available for full commercial use, further information (product overview and demo, results of internally completed studies, further details of product development plans) can only be provided confidentially to fully disclose this revolutionary device.

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

The system has been validated through internal clinical diagnostic comparison to venous and capillary blood using traditional collection methods on a wide array of assays. Safety and Efficacy studies are being planned to support regulatory submission in the US. The testing results to date demonstrate the system delivers high quality sample with low haemolyses in consistent high volumes, with a better patient experience than traditional capillary collection methods.  This device builds upon BD’s vast experience and excellence in blood collection and Babson’s Diagnostics expertise in Retail Blood Testing.

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

The system is not yet regulatory approved. Limited deployment through an investigational use or research use pathway could be discussed and could start in the second half of 2020 with a small batch production. 

What is the likely production volume?​

Short term, limited deployment could be a few thousands of units in 2020. Production volume at launch is intended to be in the millions of units per year.

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

This product has been designed for mass adoption and for use by users not trained in phlebotomy.  We envision this product ushering in a new era of easy blood collection.

Who are you already partnering with on this?

We have co-developed this device with Babson Diagnostics. Please see our recent press release for further details: https://investors.bd.com/news-releases/news-release-details/bd-babson-diagnostics-announce-strategic-partnership-agreement.  We are free and clear to sell this device in collaboration with Babson Diagnostics globally.

How does this fit into a tracked sample pathway?

This collection device will have positive ID via unique barcodes built into the collection device simplifying tracking.

edited on Apr 29, 2020 by Marina Belova
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Bev Matthews May 3, 2020

The idea has been progressed to the next milestone.

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Bev Matthews May 3, 2020

Status labels added: B: One to watch, E: Requires a connection

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Bev Matthews May 3, 2020

Hello Marina, thank you for your solution, which has been reviewed. We will be in contact shortly with a fuller response

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Tom Jordan Jul 16, 2020

Hello Marina,

Thanks for sharing this. In light of the MHRA's 8 June letter on results using capillary blood sample collection kits, we are not able to pursue this at the moment. As with all ideas on the platform we are keeping a record of what people have posted in case it is helpful to make future contact.

I hope you understand and we're very grateful again for your input on the platform.

Tom
Testing Methods team

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Tom Jordan Jul 16, 2020

Status label added: A: Not for current challenges

Status labels removed: B: One to watch, E: A connection is helpful

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Bev Matthews Aug 25, 2020

The idea has been progressed to the next milestone.

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