The approval will enable the company to start delivering RHINOstic to Canadian laboratories.
Rhinostics has secured approval from Health Canada for the commercialisation of its RHINOstic Automated Nasal Swab for medically supervised collection or self-collection for adults.
The patent-pending nasal swab received Covid-19 medical device authorisation for importation or sale from the authority. This will enable Rhinostics to start delivering RHINOstic to Canadian laboratories.
Rhinostics president and CEO Cheri Walker said: “The Health Canada approval for our RHINOstic represents an important milestone in our regulatory and commercialisation strategies, validating the clinical performance of our novel nasal swabs compared to flocked nasopharyngeal products.
“More importantly, any Canadian involved in swab sample collection or processing, from patient to clinician to lab technician, can now experience the positive and lasting impact of our innovative automated swab technologies.”
RHINOstic is a polypropylene-based sterile nasal swab, which comes with a cap that supports automated decapping.
Once the nasal sample is collected, the swab is placed in a tube for transport. According to the company, the hydrophobic material and lack of viral transport media (VTM) reduce reagent costs as well as leaking risks.
Rhinostics further said that up to 96 samples can be accessioned, decapped and processed into assay plates simultaneously, using a hands-free workflow process with robotic decapper and automated liquid handler.
The technology will support high-throughput workflows with little manual intervention. Laboratories will also be able to manage and process an increased number of Covid-19 tests during outbreaks, without needing to hire temporary workers.
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