Abionic Receives CE Mark for Sepsis and Iron Deficiency Point of Care Diagnostics

09.01.2017 14:31

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Abionic Abioscope

Abionic SA announced today the receipt of CE Mark (Conformité Européenne) for two novel tests using its easy to use testing platform, abioSCOPE. The CE Mark allows Abionic to commercialize its tests for sepsis risk assessment and management (PSP Test) and iron deficiency throughout the European Union.

“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,” stated Dr. Nicolas Durand, CEO of Abionic. “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. The iron deficiency test will be available in early 2017, whereas the sepsis risk assessment test is planned for sale in 2018.”

PSP IVD CAPSULE (sepsis risk assessment and management test)
According to clinical studies, pancreatic stone protein (PSP) is a very promising biomarker to aid in identifying patients at risk sepsis, with a sensitivity and specific superior to other biomarkers currently used, such as CRP, PCT and white cell blood count. However, measuring this information can only be helpful if it is rapidly and easily available to clinicians. The abioSCOPE can measure PSP in five minutes at the point-of-care, with high sensitivity and selectivity. 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). The resulting data enables clinicians to take the best, potentially life-saving decision for the benefit of the patient.

Sepsis is the most common causes of mortality in intensive care units. Sepsis is a syndrome characterized by an overwhelming systemic response to infection, which can rapidly lead to vital organ dysfunction, and death. Sepsis accounts for 40% of total ICU expenditure. Every year, 18 million individuals die from sepsis. Early diagnosis and management of sepsis greatly improves chances of survival and mitigates the risk of suffering from severe, long-term, complications.

Ferritin IVD CAPSULE (iron deficiency test)
Serum ferritin is an excellent 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 (picomolar) concentrations, the abioSCOPE platform and its nanofluidic sensors are the only technology able to provide ferritin measurement within minutes at the point-of-care. Comparison studies on ferritin IVD CAPSULE have shown sensitivity and precision of 89% and specificity of 83%, which shows a good comparison with the results obtained by the standard reference device but at a fraction of the time (5 minutes). This test will be available at pharmacies and the GPs office.

(Press release)

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