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Abionic wins CE mark for sepsis and iron deficiency tests

MDBR Staff Writer Published 10 January 2017

Abionic has secured CE mark approval for most rapid sepsis and iron deficiency point of care diagnostics.

The CE Mark enables the company to commercialize its tests for sepsis risk assessment and management (PSP Test) and iron deficiency throughout the European Union.

The PSP IVD Capsule sepsis risk assessment and management test uses abioSCOPE diagnostic device, which can measure pancreatic stone protein (PSP) in five minutes at the point-of-care with high sensitivity and selectivity.

Abionic said a good comparison has been observed between the PSP measured values in an ELISA microtiter (industry standard) and the abioSCOPE over a wide dynamic range (3 to 400 ng/ml).

Ferritin IVD Capsule is an iron deficiency test, which will investigate iron metabolism-related diseases such as iron-deficiency anemia.

The test also uses abioSCOPE platform that will offer ferritin measurement within minutes at the point-of-carre.

Low iron store will result in several symptoms, including fatigue, headache and general weakness, and is the frequent nutritional deficiency across the globe.

The abioSCOPE is a CE-marked device, which offers rapid medical diagnostic test results. It includes fully automated fluorescent microscope and mounting plate called abioDISC that is placed onto a single-use disposable IVD Capsule.

The sample is placed into the IVD Capsule and the abioDISC is inserted into the abioSCOPE, once the preparation gets completed.

Later, the results are presented on a high-resolution touch screen and saved onto a SD card in a few minutes.

Abionic CEO Nicolas Durand said: “These newly CE Marked tests are potentially game changing in each of their respective markets.

“In sepsis, there is a significant need in for a rapid and accurate test that will enable treatment quicker while minimizing the use of antibiotics when they are not needed.”