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Trajan’s Mitra Microsampling Devices and Kits Receive IVD Registration in Australia

July 2023 — Trajan Scientific and Medical, a leader in analytical and life sciences products, has registered its Neoteryx remote blood microsampling Mitra® devices and Mitra® Sample Collection Kits under a new manufacturing label.

The Mitra is classified as a Class I in vitro diagnostic (IVD) medical device by the Therapeutic Goods Administration (TGA) in Australia, while the Mitra® Sample Collection Kit is now classified as a Class IIa medical device for home use. Mitra 2-Sampler Cartridge and Collection Kit

The regulatory update allows Trajan's Mitra microsampling products to be used in a wider range of settings, including clinical facilities and home environments, to promote telehealth and personalized medicine. This will be especially beneficial for doctors and researchers who want to increase clinical trial participation, therapeutic drug monitoring and remote routine health checks, amongst Australia's rural communities, non-traditional participants, and individuals with limited access to clinical facilities.

The Mitra Sample Collection Kits can simply be mailed to these populations for self-guided specimen collection.

mitra sample collection-1

Using the Mitra device is a game-changer for individuals participating in clinical studies who are averse to blood draws or are unable to make it to a clinic for a blood draw. It's very easy to use and requires only a quick finger-stick method, making it accessible to virtually anyone.

Once the sample is collected, the patient or study participant can simply send it to the lab using the provided specimen bag and envelope in the home kit.

scan mitra vams tip

The microsamples integrate with laboratory analysis workflows, as shown in previous studies conducted by pharmaceutical companies, healthcare organizations, and academic research institutions around the world. As published in the literature, specimens collected with Mitra Kits have been used to study inflammatory biomarkers, PSA for prostate cancer screenings, antibodies against SARS-CoV-2, and more. 

“The updated regulatory registration of Trajan’s Mitra microsampling devices in Australia increases our ability to facilitate personalized, preventative data-based healthcare,” said Stephen Tomisich, CEO and founder, Trajan. “Our Mitra microsampling solutions allow almost anyone to take an analytically viable sample in or out of a clinical setting, anytime, anywhere.”

About Trajan Scientific and Medical
Trajan is a global developer and manufacturer of analytical and life sciences products and devices founded to enrich personal health through scientific tools and solutions. We aim to support science that benefits people. Trajan’s products and solutions are used in the analysis of biological, food, and environmental samples. Trajan has a portfolio and pipeline of new technologies which support the move towards decentralized personalized data-based healthcare.

Trajan comprises more than 680 people with seven manufacturing sites across the US, Australia, Europe, and Malaysia, and operations in Australia, the US, Asia, and Europe. Trajan’s products and solutions are marketed under multiple product brands, including Neoteryx, serving a range of industries in countries around the world. For more information, visit www.trajanscimed.com

About Neoteryx, Microsampling Solutions by Trajan
Neoteryx, a world leader in microsampling devices, was acquired by Trajan in 2021. Today, Trajan’s microsampling solutions carry the Neoteryx brand. The Neoteryx range of microsampling products provide precise, quantitative remote specimen collection. They are easy to use and amenable to automated analysis in the lab, easing workflows and enabling decentralized research and healthcare models.

The product portfolio includes the Mitra® device based on VAMS® technology and the hemaPEN® that advances both capillary and dried blood spot (DBS) technologies, with more microsampling products in the pipeline. For more information on Trajan’s Neoteryx range of microsampling solutions, visit www.neoteryx.com

Related Stories in the News: https://www.medicaldevice-network.com/news/trajan-blood-microsampling-devices-uk/ 

Learn how others apply microsampling to advance research and healthcare in a range of industriesIn some territories our devices are supplied for therapeutic or IVD use Outside of those territories our devices are supplied for research use only

Image Credits: Trajan, Neoteryx

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