DBS System SA announced today that its blood collection device, HemaXis™ DB 10, has been registered with the Swiss Agency for Therapeutic Products (SwissMedic), and is now CE/IVD marked following the 98/79/EC In vitro Diagnostic Medical Device Directive. HemaXis DB 10 is DBS System’s first-generation device for the collection, transport and storage of a precisely metered quantity of capillary whole blood sample, through a prick at the patient’s fingertip.
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 significantly modify existing laboratory workflows. With the CE mark applied on HemaXis™ DB 10, DBS System will target sales to certified labs performing analysis for clinical trials, diagnostic and wellness testing to monitor health, offering a simple, less invasive and highly cost-efficient alternative to traditional blood collection, thereby overcoming the worldwide challenges blood collection has faced for decades.
DBS System’s device uniquely allows for the patient friendly and standardized collection and storage of an accurate quantity of whole blood. The integration of an industry standard filter paper card for sample storage enables fully automated extraction and analysis using existing equipment. In addition, HemaXis™ DB 10 simplifies the logistics chain because cold storage is not required, 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.
“Obtaining the CE mark is a major milestone for DBS System as it will enable us to penetrate the European market by building strong partnerships and a platform for growth in Switzerland and Europe. Coupled with the already secured FDA clearance for the US market, we are now in a position to engage several major research and commercial labs across the two biggest markets of the world, 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.