The test has also been cleared for US marketing by the FDA under the 510(k) procedure. The forthcoming global launch of this new test will now incorporate the US, following the regulatory clearance received from the FDA.
Ian Gilham, CEO of Axis-Shield, said: “We are pleased to be launching this proprietary assay on Abbott’s flagship Architect system. The importance of measuring homocysteine blood levels on a regular basis is now more widely recognised and the availability of this marker on Architect should help to develop the market and increase the frequency of testing.”