Medical Devices and Healthcare IT

Video: FDA Registration for World’s Most Rapid Allergy Test and abioSCOPE® Diagnostic Testing Platform

26 October 2017

Abionic SA (Lausanne, Switzerland), a developer of nanotechnology-based rapid diagnostic solutions, announced that its rapid allergy test, IVD CAPSULE Aeroallergens, and the easy to use testing platform, abioSCOPEâ have been registered by the U.S. Food and Drug Administration (FDA).

Using the abioSCOPE platform, sensitization to common respiratory allergies can be tested directly from a (Source: Abionic)(Source: Abionic)single drop of blood, allowing patients to save several visits and invasive tests. The IVD CAPSULE Aeroallergens determines patient’s sensitization to cat and dog allergens, as well as common grass and tree pollens.

Blood samples from a panel of allergic and non-allergic patients have been tested and an excellent correlation between the IVD CAPSULE Aeroallergens on abioSCOPE and the laboratory gold standard method has been demonstrated. With a first result in 5 minutes and a total assay time of as little as 8 minutes for determination of immunoglobulin E levels to the four allergens of the test, the abioSCOPE is the most rapid quantitative antibody assay available.

“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 commercialization 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,” said 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.”

About the abioSCOPE®

The abioSCOPE is composed of a fully automated fluorescent microscope and a mounting plate (the abioDISC), onto which is placed a single-use disposable IVD CAPSULE. Following preparation, a sample is placed into the IVD CAPSULE and the abioDISC is inserted into the abioSCOPE, in the same way that a DVD is inserted into a player. The resulting molecular complexes formed are optically detected by means of the integrated laser and in a few minutes the results are presented on a high-resolution touch screen. The abioSCOPE can be used by any healthcare professional having CLIA certified facilities and does not require extensive training. In addition to FDA registration, the abioSCOPE has CE Mark.

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