FDA Approves Abionic’s 5-minute Allergy Test – Pharma testing
The Allergy season may be over, but before the next one arrives, you may want to figure out exactly what is causing your runny nose, itchy eyes, and other symptoms.
And figuring that out is now easier than ever- requiring you to spare just about five minutes time – with the newly approved AbioScope platform from Abionic.
The Food and Drug Administration (FDA) has approved what people are calling the “world’s most rapid” allergy test. The Swiss Federal Institute of Technology in Lausanne (EPFL), its spinoff Abionic in particular, has developed the innovative AbioScope, a test platform that requires just one drop of blood to determine what you are allergic to.
Using the bioscope 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 a 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.After combining the blood with a reagent, the tester will place the mixture on the platform’s DVD-like mounting plate (see above) and allow it to form complex molecular complexes with the test capsules. Initial results will pop up on abioSCOPE’s screen in five minutes — the full results are due three minutes later. The system uses the integrated fluorescent microscope’s laser to check for the presences of those complexes, so you can quickly find out if you’re allergic to dogs, cats, common grass and tree pollens. Sure, the system can only test for four kinds of allergens, but at least you don’t have to undergo anything uncomfortable or invasive just to find out you’re allergic to your lawn.
“The FDA registration for the Bioscope 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 the testing platform, providing allergy sufferers a more convenient and time efficient testing experience,” stated Dr. Nicolas Durand, CEO of Abionic. “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.”
