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biosurfit gets CE mark for spinit HbA1c blood test

MDBR Staff Writer Published 01 December 2016

In vitro point-of-care (PoC) diagnostics firm biosurfit has secured CE mark for its spinit Haemoglobin A1c (HbA1c) test.

With the latest approval, the spinit PoC diagnostic system can be used to perform three major blood tests, including haematology, immunoassays and clinical chemistry.

The HbA1c test will enable physicians to diagnose and monitor diabetes, in addition to identifying patients at risk of developing diabetes.

biosurfit’s clinical chemistry HbA1c test helps to manage the progression of disease in few minutes by using only 5µl blood sample through tiny finger stick.

According to the company, the spinit test will provide cost-efficiencies for physicians with the use of one instrument.

Currently available tests for the spinit instrument include c-reactive protein (CRP) and blood count (BC).

The combination of different detection methods on the CD/DVD format of the spinit disc along with microfluidics will allow to develop new products, including lipid panel, inflammation panel and d-dimer test.

Biosurfit CEO João Garcia da Fonseca said: “We are delighted to have secured this new and important milestone in the continuous development of spinit.

“It is a clear testament to its disruptive, technical viability and rising commercial acceptance in setting the future gold standard in IVD PoC diagnostics.”

biosurfit chairman Ian Gilham said: “CE-Marking of the HbA1c test is a major milestone in the development of the spinit instrument and test menu providing an indispensable aid to patients and physicians in their fight against diabetes.”