LISBON, Portugal--(BUSINESS WIRE)--Today, biosurfit SA (“biosurfit”), the in vitro point-of-care (PoC) diagnostics company, announces CE Marking (Conformité Européenne) for its HbA1c (Haemoglobin A1c) test, the third in a series of tests available on its spinit® point-of-care instrument.
The CE Mark approval of the HbA1c clinical chemistry test signifies the latest advancement of biosurfit’s spinit®, the first and only, PoC diagnostic system capable of performing all three of the major blood tests (haematology, immunoassays and clinical chemistry) on the same instrument. The spinit® test could also signal cost-efficiencies for physicians who can now use just one instrument, instead of several ones. Existing, commercially launched tests for the spinit® instrument include CRP (c-reactive protein) and BC (blood count).
The HbA1c test is one of the key diagnostic tests used by physicians to diagnose and monitor diabetes as well as to identify patients at risk of developing diabetes. With a requirement for a tiny finger stick blood sample of only 5µl, the new spinit® clinical chemistry HbA1c test allows physicians to manage the progression of this very serious disease in a few minutes. HbA1c is one of the most commonly used PoC tests performed in physicians’ offices. With the CE marking of biosurfit’s spinit® HbA1c test, biosurfit is now able to offer this valuable tool to help physicians efficiently diagnose and monitor diabetes without having to collect and send blood samples off to a central laboratory.
With the new HbA1c test, along with CRP and Blood cell counting, biosurfit now offers a comprehensive menu of fast, easy to perform laboratory quality tests on the spinit® instrument. The combination of different detection methods on the CD/DVD format of the spinit® disc along with powerful microfluidics will facilitate the development of the pipeline of products in the near future, including a lipid panel, an inflammation panel and a d-dimer test. This attractive menu of tests, on a rapid and simple to use instrument will allow the performance of these key tests in GP offices, clinics, pharmacies and other PoC testing sites.
João Garcia da Fonseca, Chief Executive Officer of biosurfit, commented: “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. We are looking forward to continuing the roll out and commercialisation of the expanded spinit® test menu in the near future.”
Ian Gilham, Chairman of biosurfit, commented: “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. We are excited by the ever expanding menu of spinit tests and the increased installed base of instruments which will be further driven by the launch of new tests and the opening of new global markets in the near future.”
Notes to editors
About biosurfit and spinit®
biosurfit is a fast-growing and highly innovative commercial stage European medical diagnostics company focused on the development and manufacture of breakthrough technologies for the in vitro diagnostic (IVD) market. Its lead product spinit®, which was commercially launched in 2014, addresses an unmet need for fast, precise, reliable, easy-to-use blood analysis for medical testing in the PoC setting.
1 International Diabetes Federation. IDF Diabetes Atlas, 7th edition, Brussels, Belgium: International Diabetes Federation; http://www.diabetesatlas.org. Accessed 6 November 2016.
2 NIH – National Institute of Diabetes and Digestive and Kidney Diseases: The A1C Test and Diabetes; www.niddk.nih.gov. September 2014.