neoteryx announces european approval of the mitra microsampling device
by Fiona Mahjoor, on August 1,2015
®Torrance, CA (August 1, 2015) – Neoteryx LLC announced today that the Mitra® Microsampling Device for the collection, transport, and storage of biological fluids has achieved CE-IVD status under the European Directive on In Vitro Diagnostic Medical Devices. This is the second in a series of microsampling solutions following the launch of the research-use-only product in June 2014.
This device, based on Volumetric Absorptive Microsampling (VAMS™) technology, accurately and reliably collects in seconds a quantitative volume of blood without hematocrit bias or other biological fluid. The patient experience is improved by eliminating painful venipuncture and minimizing needle anxiety. The device’s clamshell format enables collection of patient samples without a phlebotomist at a variety of convenient locations such as hospital labs, collection centers, physician offices, and at-home
In addition to patient benefits, the CE-IVD Mitra Microsampler delivers several advantages to laboratories. The design features facilitate simple, accurate sampling with little training. Once collected, samples can be immediately dried for non-biohazard shipping under ambient conditions, eliminating costly cold shipping and couriers.
“The release of the CE-IVD Mitra Microsampling Device is a major advance for labs and hospitals in the EU working with clinical samples insofar as it will improve patient experience, open opportunities for at-home patient monitoring, and significantly reduce sample workflow and transportation costs ,” says Bert Rietveld, Neoteryx President. “Together with our partners, we intend to continue expansion of our microsampling solutions as well as work hand-in-hand with them to design sample collection solutions that leverage the many benefits of microsampling.”
The Mitra CE-IVD Microsampler is suitable for patient populations that have low blood flow such as pediatrics, elderly, or oncology as well as those in difficult to reach populations for large epidemiological studies.
The Mitra Microsampler class I medical device is for direct specimen collection of blood and other biological fluids. It is not specific to any clinical test, and is not for use in diagnostic procedures. Use of the Mitra Microsampler in Laboratory Developed Tests (LDTs) requires further processing including the establishment of performance characteristics and successful validation by the laboratory in a manner consistent with CLIA requirements.