Rhinomed has successfully registered its easy to use, high load capturing, comfortable nasal swab with the Australian Therapeutic Goods Administration (TGA) as a Class 1 device.
The new swab can comfortably collect samples from both nostrils simultaneously to test for the presence of upper respiratory tract diseases including influenza and coronavirus including SARS-CoV-2. The unique design not only enables a larger sample to be collected but also opens up the opportunity for mass, high frequency testing; a critical strategic response to pandemics such as Covid-19.
This news follows last week’s announcement that Rhinomed had successfully registered this novel nasal swab with the US FDA as a Class 1 device to collect samples.
The issue of the Australian Register of Therapeutic Goods (ARTG) number confirms the device has been included in the ARTG and therefore Rhinomed may commence supply of the device immediately.
The new nasal swab builds on the company’s expertise as a world-leading developer of nasal devices. Rhinomed’s existing FDA and TGA registered nasal products; Mute (anti-snoring), Pronto (anti-nasal-congestion and sleep improvement) and Turbine (improved breathing for sports) have been worn comfortably and safely since 2016. Rhinomed sells these products in over 20,000 pharmacies worldwide.
Rhinomed’s novel nasal swab is designed to be:
- Less invasive and more comfortable than standard nasopharyngeal swabs;
- Unique as it collects sample from both nostrils simultaneously, doubling the sample volume collection potential;
- Able to collect samples from a far greater surface area of the nose than normal swabs;
- Designed to fit into existing vials and work with existing pathology workflows;
- Able to be self-administered easily, anywhere, reducing the risk of infection of healthcare workers,
- Able to be used by a large number of people, everyday; and
- Provide improved repeatability and reliability of swabbing.
The Company is now rapidly scoping out local and foreign manufacturing, assessing additive manufacturing (3D printing) solutions and advancing discussions with potential commercial partners. Further details on the clinical and commercial program will be announced in due course.