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

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  • Test detects sensitization to four common respiratory allergens in United States
  • Scheduled to be commercially available in the US in 2018

[junkie-alert style=”red”] Abionic SA, a developer of disrupter nanotechnology based rapid diagnostic solutions, announced today that its rapid allergy test, IVD CAPSULE Aeroallergens, and the easy to use testing platform, abioSCOPE® have been registered in the United States by the Food and Drug Administration (FDA). Abionic intends to commence commercialization of IVD CAPSULE Aeroallergens in this market in 2018. [/junkie-alert]

Platform:  Using the abioSCOPE platform, sensitization to common respiratory allergies can be tested directly from a single drop of blood, allowing patients to save several visits and invasive tests and while guaranteeing medical diagnosis of the highest quality. The IVD CAPSULE Aeroallergens determines patient’s sensitization to cats and dogs’ major allergens, as well as common grass and tree pollens. Depending on the results, allergy experts who run laboratories that meet CLIA standards for moderately complex testing have now access to a new technology that allows them to quicker and better assess what triggers allergic symptoms, which is key to optimize clinical management of the disease.

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 have been demonstrated. With a first result in 5 minutes and a total assay time of as little as 8 minutes for determination of IgE levels to the four allergens of the test, the abioSCOPE is the most rapid quantitative IgE antibody assay available.

Dr. Nicolas Durand, CEO of Abionic remarked, “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.”  Dr. Durand, concluded, “There are 25 million adults in the US who suffers 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.”