NEW YORK (360Dx) – Abionic announced today that two diagnostic tests for its abioSCOPE platform, PSP IVD Capsule and Ferritin IVD Capsule, have received the CE mark for marketing in the European Union.
The abioSCOPE is the company's CE-marked diagnostic device. It is composed of a fully automated fluorescent microscope and a mounting plate where clinicians can place an IVD Capsule to test for their disease of interest.
"These newly CE-marked tests are potentially game changing in each of their respective markets," Abionic CEO Nicolas Durand said in a statement. "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. 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 PSP IVD Capsule uses the abioSCOPE platform to measure the levels of pancreatic stone protein (PSP), which clinical studies have determined is a promising biomarker to identify patients at risk of sepsis. In intensive care units, sepsis is the most common cause of mortality. The test can measure PSP levels in five minutes to give clinicians rapid result, which enables them to make the best decision to benefit the patient, the company said.
The Ferritin IVD Capsule measures serum ferritin levels in blood, which is a biomarker for the amount of available iron stored in the body. The marker is only present in very low concentrations. The abioSCOPE platform uses its nanofluidic sensors to measure ferritin levels within minutes, the company said.
The iron deficiency test will be available in early 2017, while the sepsis risk assessment test is planned to launch in 2018, Durand said.