FDA's scrutiny

5-minute allergy test passes the FDA’s scrutiny


20.10.17 – The us Food and Drug Administration has simply registered Abionic’s rapid allergy diagnostic system, that tests for sensitivity to four common respiratory allergens within the us. This puts the EPFL spin-off {on track|on target|on course|on the right track|heading within the right direction|not off course} to market its single-use capsules and testing platform in the us in 2018.


It takes only 5 minutes and one drop of blood for Abionic’s abioSCOPE® to produce a preliminary yet extremely reliable diagnosis of a patient’s allergies. The system, that the company describes because the “world’s most rapid” allergy test, has just been registered by the US Food and Drug Administration and is set to hit the US market in 2018. it’s already been certified for use in Europe. The system comprises test capsules for four common allergies along with a portable testing device. “There are twenty five million adults within the US who suffer from allergic rhinitis, a number that’s constantly increasing,” says Dr. Nicolas Durand, the company’s chief executive officer.


This diagnostic solution came out of EPFL’s Microengineering Laboratory and development work was taken over by the startup in 2010. it’s composed of a fully automated fluorescent microscope and a mounting plate that resembles a DVD onto that a disposable capsule is placed. A drop of blood is combined with a reagent and placed on the plate. using patented nanotechnology and diffusion phenomena, the molecules interact in biosensors placed on the capsules and form specific molecular complexes. These complexes are optically detected by means of an integrated laser. after several minutes, the results appear on a high-resolution touch screen and saved on an sd card provided by the company.


It takes only 5 minutes for the initial results and eight minutes for the total assay time, in which the ige levels associated with the four allergens are measured. The system is extremely easy for healthcare professionals to use and doesn’t require extensive training. It also spares patients the need for several doctor’s visits and invasive tests. The platform has been sold in Switzerland for several years and holds the eu Union’s ce marking.


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