Trajan Scientific and Medical (Trajan) has declared hemaPEN® compliance with EU IVD Directive 98/79/EC, and its release for in vitro diagnostic use in the EU and UK. This follows the hemaPEN’s recent addition to the TGA’s ARTG (Australian Register of Therapeutic Goods) in February as a Class 1 IVD device.
This enables hemaPEN to be used to collect blood microsamples for clinical trials, diagnostics and applications to monitor health.
hemaPEN provides a convenient sampling procedure for collection and storage of four dried blood spot (DBS) samples. Unlike conventional DBS sampling tools, hemaPEN enables collection of an accurate and precise fixed micro-volume and is designed to maintain sample integrity for quantitative analysis. An easy-to-use sophisticated microsampling tool in the hands of non-analysts.
In today’s environment, where whole communities are practising self-isolation due to COVID-19, remote microsampling facilitates ongoing blood monitoring of chronic disease, and enables continuity-of-care for vulnerable members of society.
Trajan’s CEO, Mr Stephen Tomisich said, “This is the tipping point for remote microsampling technology; alongside e-health consultations and e-prescription we are moving to a more remote healthcare system.”
Dr Anne Collins, Trajan’s Business Unit General Manager, Microsampling, said, “hemaPEN’s adoption in ongoing medical treatment and monitoring would remove the need for travel, reduce pressure on healthcare workers, and eliminate expensive cold chain logistics.”
Trajan believes in science that benefits people – creating portable and affordable measurement solutions, enabling accurate results to inform preventative healthcare.
Visit www.hemapen.com to purchase or learn more about hemaPEN, and to sign up for updates.
To learn more about Trajan’s microsampling technologies and capabilities visit www.trajanscimed.com/microsampling.
Press release [PDF]
Deprez, S. et al. “Evaluation of the Performance and Hematocrit Independence of the hemaPEN as a Volumetric Dried Blood Spot Collection Device.” (Analytical Chemistry 2019 91 (22), 14467-14475)
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Trajan Scientific and Medical’s hemaPEN® has been independently evaluated and the results of the study published in the Royal Society of Chemistry’s journal Analyst - selected for the cover of issue 17. hemaPEN demonstrated significant advantages for blood sampling to support better healthcare decision making.
Trajan Scientific and Medical has listed its hemaPEN® blood microsampling device with the U.S. Food and Drug Administration as Class I for therapeutic and in vitro diagnostic use. This follows the hemaPEN’s recent registration in May for supply in the EU and UK as a General IVD; as well as inclusion in the TGA’s ARTG (Australian Register of Therapeutic Goods) in February as a Class I IVD.