The US Food and Drug Administration (FDA) has registered Swiss diagnostic solutions provider Abionic’s abioSCOPE testing platform and rapid allergy test, IVD CAPSULE Aeroallergens.

Common respiratory allergies can be tested on the new diagnostic platform with a single drop of blood, eliminating the need for multiple visits and invasive tests.

Go deeper with GlobalData

Go deeper with GlobalData

The gold standard of business intelligence.

Find out more

Discover B2B Marketing That Performs

Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.

Find out more

The testing platform, which features a fully automated fluorescent microscope, uses nanotechnology and diffusion phenomena to form specific molecular complexes that are detected through an integrated laser.

In addition to common grass and tree pollens, the IVD CAPSULE Aeroallergens test can be used to find out patient’s sensitisation to major allergens from cats and dogs.

The new technology enables allergy experts to quickly evaluate the reason for trigger of allergic symptoms, aiding in optimised disease management.

“We hope to bring new treatment options to patients where significant unmet medical need remains.”

Abionic CEO Dr Nicolas Durand said: “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 commercialisation and a staged market entry of this revolutionary technology.

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData

“We can now look to offer a rapid, easy-to-use testing platform, providing allergy sufferers a more convenient and time efficient testing experience.”

Upon testing blood samples from allergic and non-allergic subjects, abioSCOPE with IVD CAPSULE Aeroallergens was found to be rapid when compared to traditional laboratory method.

abioSCOPE is reported to have detected quantitative IgE antibody levels to four allergens of the test during a total assay time of eight minutes, with the first result delivered in five minutes.

The firm plans to begin commercialisation of the allergy test in the country next year and is seeking relevant partners for distribution.

 

Medical Device Network Excellence Awards - Nominations Closed

Nominations are now closed for the Medical Device Network Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact

Excellence in Action
HemoSonics has won the 2025 Marketing Award for its impactful promotion of theQuantra Hemostasis System and leadership in blood management education. See how targeted campaigns, thought leadership content, and hands on clinician training are accelerating Quantra’s market traction and shaping the future of hemostasis testing.

Discover the Impact