Nasal swab Registered With US FDA

Rhinomed Limited is pleased to announce that it has successfully registered its novel nasal swab with the US FDA as a Class 1 device to collect samples from the nose to detect upper respiratory tract diseases including influenza and coronavirus strains.

The successful registration and conformity with the relevant standards means that Rhinomed’s novel nasal swab is now able to be sold in the US market.

The new nasal swab is an extension of Rhinomed’s nasal technology platform and intellectual property patent portfolio using the company’s depth of experience as a world-leading developer of nasal devices. Rhinomed’s existing nasal products have been worn comfortably and safely since 2016 and are sold in more than 20,000 pharmacies worldwide.

Rhinomed’s nasal swab is:

  • Less invasive and more comfortable than standard nasopharyngeal swabs;
  • Unique as it collects samples from both nostrils simultaneously.
  • Able to collect samples from a far greater surface area of the nose than normal swabs;
  • Able to be self-administered easily, anywhere, reducing the risk of infection of healthcareworkers; and
  • Able to be used by a wide number of people every day.

Rhinomed’s nasal swab is designed for self-collection in the home, workplace or in a clinical setting under supervision and is expected to address the problems with current nasopharyngeal swabs that are highly invasive and uncomfortable. Most existing nasal swabs require a healthcare worker to collect the sample, which places the healthcare worker at risk of infection. The use of healthcare workers and the requisite personal protection equipment (PPE) also comes with significant cost.

The new Rhinomed swab is designed to be able to collect a larger sample, be worn for a predetermined time (it remains snugly in place) and collect a sample from both nostrils simultaneously, thus offering the potential for a more effective diagnostic sample. The swab has been designed to fit into existing vials and work with existing pathology workflows.

The Company is now rapidly scoping manufacturing and is assessing additive manufacturing (3D printing) solutions, existing offshore manufacturing resources and assessing the viability of local manufacturing.

Rhinomed is advancing discussions with potential commercial partners in respect to the program. Further details on the clinical and commercial program will be announced as further progress occurs.

Read the announcement here