Swiss developer of nanotechnology-based rapid diagnostic solutions Abionic SA announced on Friday that its rapid allergy test, IVD CAPSULE Aeroallergens, and its testing platform, abioSCOPE, have been registered in the United States by the Food and Drug Administration (FDA).
The abioSCOPE platform tests sensitisation to common respiratory allergies by testing them directly from a single drop of blood. This process frees patients from having to make several visits to the hospital and avoids the need for multiple, invasive tests.
Abionic's IVD CAPSULE Aeroallergens determines a patient's sensitisation to cats and dogs' major allergens, as well as common grass and tree pollens. The company hopes to begin commercialisation of IVD CAPSULE Aeroallergens in the US market in 2018.
"The FDA registration for the abioSCOPE and our first allergy test is a major milestone for Abionic and an important regulatory step that sets the stage for commercialisation and a staged market entry of this revolutionary technology. We can now look to offer a rapid, easy to use testing platform, providing allergy sufferers a more convenient and time efficient testing experience," commented Dr Nicolas Durand, CEO of Abionic.
"There are 25 million adults in the US who suffer from allergic rhinitis, a number that is constantly increasing. We are now working to secure the right distribution partners to ensure we can address this major market in 2018."
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