The United States Food and Drug Administration has just registered Abionic’s rapid allergy diagnostic system, which tests for sensitivity to four common respiratory allergens in the United States. This puts the EPFL spin-off on track to market its single-use capsules and testing platform in the US in 2018.
It takes only five minutes and a single drop of blood for Abionic’s abioSCOPE to produce a preliminary yet highly reliable diagnosis of a patient’s allergies. The system, which the company describes as 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 has already been certified for use in Europe. The system comprises test capsules for four common allergies along with a portable testing device. "There are 25 million adults in the US who suffer from allergic rhinitis, a number that is constantly increasing," says Dr. Nicolas Durand, the company’s CEO.
This diagnostic solution came out of EPFL’s Microengineering Laboratory and development work was taken over by the startup in 2010. It is composed of a fully automated fluorescent microscope and a mounting plate that resembles a DVD onto which 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 five 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 does not 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 European Union’s CE marking.