On 16 March, Roche announced that it has received CE mark approval for its Elecsys® Apolipoprotein E4 (ApoE4) biomarker test – the first in-vitro diagnostic (IVD) immunoassay capable of identifying the presence of the ApoE4 genetic variant in blood. The ApoE4 gene variant is a well-established genetic risk factor associated with an increased risk of late-onset Alzheimer's disease (AD) and is found in approximately 40–60% of people diagnosed with the condition.
The Elecsys ApoE4 test provides a simple, fast and reliable option, using a minimally invasive blood sample, to identify whether an individual carries the ApoE4 variant.
"The approval of the Elecsys ApoE4 biomarker test is an important step forward in providing clinicians with a simple, accessible tool to identify genetic risk and guide Alzheimer's treatment decisions," said Matt Sause, CEO of Roche Diagnostics. "By helping clinicians quickly identify and triage ApoE4 carriers among patients with cognitive decline, the test simplifies the diagnostic process as well as patient management."
https://www.prnewswire.com/news-releases/roche-receives-ce-mark-for-first-ivd-immunoassay-blood-test-to-identify-carriers-of-apoe4-a-genetic-variant-present-in-up-to-60-of-patients-diagnosed-with-alzheimers-disease-302714082.html
