Neoteryx’s Mitra Device Registered with Australian TGA

The Mitra microsampling device from U.S. company Neoteryx has been registered as a Class I in vitro diagnostic (IVD) medical device with the Therapeutic Goods Administration (TGA) in Australia.
 
Designed for remote use, Mitra devices enable anyone to collect their own blood at home with a simple finger-stick method. The Mitra device is based on volumetrically absorptive microsampling (VAMS) technology, which enables a scientifically precise volume of blood to be collected on its absorbent tip. Doctors, researchers and labs in Australia can send Mitra devices and Mitra Blood Collection Kits to patients or clinical trial participants who must stay safe at home or who live in remote areas. A key advantage of Mitra is that no visit to a clinic or phlebotomist for a blood draw is necessary—this easy-to-use device collects a high-quality blood sample for accurate, validated lab testing for clinical diagnostics that inform decisions about medical treatment.
 
“With the TGA registration, Mitra microsampling devices and Mitra Blood Collection Kits from Neoteryx can be imported into Australia for use in both research and clinical diagnostic applications,” said Loc Huynh, MS, RAC, regulatory affairs and quality director, Neoteryx.
 
Blood samples collected with Mitra are protected in a cartridge and a sealed bag within an envelope for mailing directly to a designated lab or health facility through regular post. Mitra dried blood samples have many applications in healthcare such as serology testing, therapeutic drug monitoring, addiction recovery testing, and managing chronic illness such as diabetes or cardiovascular disease. Mitra microsamples are ideal for telehealth, pediatric care, remote patient monitoring for vulnerable patients or those participating in virtual clinical trials, and public health studies. 
 
“Patient-centric blood collection at home using Mitra devices is more relevant than ever during the coronavirus pandemic, because in-clinic blood draws and wellness visits pose a risk of exposure to the virus,” said James Rudge, PhD, technical director at Neoteryx. “Physicians find Mitra microsampling extremely useful for remote patient monitoring of their vulnerable patient populations.”