Abionic SA, Lausanne, Switzerland, has received the CE mark for two novel tests using its AbioScope testing platform. The CE mark permits Abionic to commercialize its tests for risk assessment and management of sepsis and iron deficiency throughout the European Union.
Nicolas Durand, PhD, Abionic.
“These newly CE-marked tests are potentially game changing in each of their respective markets,” says Nicolas Durand, PhD, CEO of Abionic. “In sepsis, there is a significant need for a rapid and accurate test that will enable treatment quicker while minimizing the use of antibiotics when they are not needed. We also have the only technology that is able to quantitatively measure ferritin levels in blood at the point of care. So, with the AbioScope, routine screening for iron deficiency can be conducted at the pharmacy or doctor’s office while you wait.”
According to the company, the iron deficiency test will be available in early 2017, whereas the sepsis risk assessment test is planned for sale in 2018.
The AbioScope testing platform is composed of a fully automated fluorescent microscope and a mounting plate called the AbioDisc, onto which is placed a single-use disposable IVD capsule. Following preparation, the sample is placed into the IVD capsule and the AbioDisc is inserted into the AbioScope, in the same way that a DVD is inserted into a player. In a few minutes, the results are then presented on a high-resolution touch screen and saved onto an SD card provided by Abionic. The AbioScope can be used by any healthcare professional and does not require extensive training.
According to clinical studies, pancreatic stone protein (PSP) is a promising biomarker to aid in identifying patients at risk of sepsis, with sensitivity and specificity superior to such other currently used biomarkers as C-reactive protein, procalcitonin, and white blood cell count. The AbioScope can measure PSP in 5 minutes at the point of care, with high sensitivity and specificity. A good correlation has been observed between the values for PSP measured by an enzyme-linked immunosorbent assay and by the AbioScope over a wide dynamic range of 3 to 400 ng/ml.
The AbioScope from Abionic.
Serum ferritin is a marker of the amount of available iron stored within the body. The first test performed to investigate potential iron metabolism-related diseases, such as iron-deficiency anemia, measures ferritin. Low iron store is often associated with several symptoms, such as fatigue, headache, and general weakness. Iron deficiency is the most frequent nutritional deficiency worldwide.
As ferritin is present in blood at extremely low concentrations, the AbioScope platform and its nanofluidic sensors offer a unique technology for measuring ferritin measurement within minutes at the point of care. Comparison studies on the company’s ferritin IVD capsule have shown sensitivity and precision of 89% and specificity of 83%.
For more information, visit Abionic.
