HemaXis DB launched in the U.S. with FDA listing

8th February 2018

DBS System SA

Enaie Azambuja

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Datasheet

DBS System has launched their HemaXis DB micro blood collection device in the United States with an FDA Class 1 medical device listing. HemaXis DB is DBS System’s first generation device for the collection, transport and storage of capillary whole blood samples. DBS System, a Swiss based company, produces blood collection devices that leverage advanced microfluidic technology to simplify and reduce the cost of blood sampling without the need to modify existing laboratory workflows.

With its U.S. market launch, DBS System will target sales to certified labs performing analysis for pre-clinical trials, pre-diagnostic and wellness testing to monitor health. HemaXis DB offers a complete and practical solution to collect precise volumes of capillary whole blood at the fingertip with levels of standardisation and reliability comparable to a micropipette.

The integration of an industry standard filter card for sample storage enables fully automated extraction and analysis using existing equipment.

In addition, the function and design of HemaXis DB simplifies the logistics chain because cold storage is not required and it fits within the existing laboratory workflow, all together resulting in significant cost savings for labs. These benefits provide a clear advantage over traditional dried blood spot collection and competitive devices being launched in the market.

“The FDA listing is an important milestone for DBS System as it will enable us to build strong partnerships and a platform for growth in the U.S., where the estimated yearly addressable market size for blood testing is USD 8 Billion.

We have several U.S. researchers and commercial labs that have evaluated HemaXis DB in exciting and growing areas such as wellness testing for preventative care and for alcohol and drugs of abuse screening especially in context of the current opioid epidemic”, says CEO Eric Ödman.

To drive rapid adoption of the HemaXis DB device, DBS System’s team of scientists also provide analytical method support to help implement HemaXis into customer labs workflow.

Last year, DBS System raised 2.5M CHF (approx. 2.5M USD) to industrialise it’s second generation HemaXis DX device that passively separates plasma or serum from whole blood, thus dramatically increasing the range of tests capable of being run on dried blood samples.

DBS System aims to establish itself as the leading manufacturer of medical devices for collecting and preparing micro samples of whole blood, plasma and serum with its patented HemaXis platform of microfluidic devices.