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October 23, 2017updated 24 Oct 2017 5:57pm

Abionic registers diagnostic platform and allergy test with FDA

The US Food and Drug Administration (FDA) has registered Swiss diagnostic solutions provider Abionic’s abioSCOPE testing platform and rapid allergy test, IVD CAPSULE Aeroallergens.

The US Food and Drug Administration (FDA) has registered Swiss diagnostic solutions provider Abionic’s abioSCOPE testing platform and rapid allergy test, IVD CAPSULE Aeroallergens.

Common respiratory allergies can be tested on the new diagnostic platform with a single drop of blood, eliminating the need for multiple visits and invasive tests.

The testing platform, which features a fully automated fluorescent microscope, uses nanotechnology and diffusion phenomena to form specific molecular complexes that are detected through an integrated laser.

In addition to common grass and tree pollens, the IVD CAPSULE Aeroallergens test can be used to find out patient’s sensitisation to major allergens from cats and dogs.

The new technology enables allergy experts to quickly evaluate the reason for trigger of allergic symptoms, aiding in optimised disease management.

“We hope to bring new treatment options to patients where significant unmet medical need remains.”

Abionic CEO Dr Nicolas Durand said: “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.”

Upon testing blood samples from allergic and non-allergic subjects, abioSCOPE with IVD CAPSULE Aeroallergens was found to be rapid when compared to traditional laboratory method.

abioSCOPE is reported to have detected quantitative IgE antibody levels to four allergens of the test during a total assay time of eight minutes, with the first result delivered in five minutes.

The firm plans to begin commercialisation of the allergy test in the country next year and is seeking relevant partners for distribution.

 

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