Microsampling Devices
Trajan's Microsampling Devices Meet IVDR Compliance in Europe, UK
Mitra® and hemaPEN®, two of Trajan Scientific and Medical's Neoteryx remote blood microsampling devices, have been given the go-ahead for clinical use in Europe and the United Kingdom, according to the company.
In accordance with the In Vitro Diagnostic Medical Devices Regulation (IVDR) in Europe and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, Trajan has successfully met the necessary product safety and performance requirements.
With this CE Mark regulatory compliance, Trajan can now offer decentralized, person-centered, minimally invasive blood collection in both clinical and research settings using its Neoteryx® microsampling products.
The Mitra device is a finger-stick blood collection option for the delivery of dried samples to the lab. It is based on volumetric absorptive microsampling with VAMS® technology. Using a single finger-stick, the hemaPEN® device, based on volumetric microsampling with capillary and next-generation DBS technology, simultaneously collects 4 equal-volume DBS blood samples.
Mitra® and hemaPEN® devices can be used remotely to collect blood samples through an easy, virtually painless process. The devices can be used to ship dried samples via standard mail and deliver precise volumes and high sample quality compared to traditional DBS or other remote blood sampling technologies.
The samples fit seamlessly into laboratory analysis workflows, as shown in studies conducted by pharmaceutical companies, healthcare organisations, and academic institutions around the world.
"The updated regulatory approval of Trajan's blood microsampling devices in the UK and European Union is another step forward towards our vision of personalized, preventative data-based healthcare," said Stephen Tomisich, CEO and founder of Trajan.
"Our growing range of microsampling technologies allows almost anyone to take an analytically viable sample outside the clinical setting, anytime, anywhere. In our view, that is essential to enable the healthcare systems of the future."
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