NEWS
Fujirebio’s IVD Alzheimer’s test gains FDA clearance
Fujirebio has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s Lumipulse G plasma ratio in vitro diagnostic (IVD) test for the assessment of amyloid pathology in patients being evaluated for Alzheimer’s disease and other causes of cognitive decline.
The test, which was previously granted
Breakthrough Device Designation by the FDA, is the first FDA cleared blood-based IVD test in the US to aid to identify patients with amyloid pathology associated with Alzheimer’s disease (AD).
New technology role at Genomics England
Genomics England has announced the appointment of Julian Thomas into the new role of Chief Technology and Product Officer. Julian joins with over 20 years’ experience leading technology and product teams through strategic leadership and hands-on delivery, including for NHS Digital and the UK Health Security Agency.
In the latter, he led a team of over 600 professionals in delivering essential digital services and clinical result data flows during the COVID-19 pandemic. He has also held key roles in the publishing, arts and consulting sectors, delivering high scale digital products. The Chief Technology and Product Officer is a newly created role to further ensure Genomics England has a solid and secure technology and product offering as the expected impact of genomics scales in the coming years. In his role, Julian will be responsible for Genomics England building and running products and technology that deliver maximum impact for patients and participants as well as partners in research, industry and the NHS.
Dr Rich Scott, Chief Executive Officer of Genomics England, commented: “We are delighted to welcome Julian. He brings a wealth of knowledge, experience and passion for the technology and product space – all of which will be invaluable as we embark on the next phase of our journey.”
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The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test is an accurate, minimally invasive, accessible measurement of pTau 217 and β-Amyloid 1-42 concentrations in plasma as a proxy for the presence of β-Amyloid plaque pathology in the brain. It is intended for use in adult patients aged 50 years and older presenting at a specialised care setting with signs and symptoms of cognitive decline. In a clinical study population of 499 patients, which closely mirrored the US demographics, and when applying a dual cut point, the test demonstrated a positive predictive value
(PPV) of 92%, a negative predictive value (NPV) of 97% with only 20% patients who are uncertain to have amyloid pathology, thus requiring further testing. The test uses Fujirebio’s fully automated LUMIPULSE G1200 instrument system, which is widely available in clinical laboratories throughout the US. “The lack of effective, accessible and minimally invasive diagnostics for AD contributes to its late diagnosis and inadequate treatment,” says Monte Wiltse, President and CEO at Fujirebio Diagnostics. “This test will go a long way to assist physicians and patients to obtain an AD diagnosis in early stages of the disease, when interventions are more effective. As part of our worldwide commitment to improve the diagnosis and treatment of AD, Fujirebio is developing additional assays, which will expand the foundation for early, more effective treatment.”
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