Despite extensive use of biomarkers in research studies, most Alzheimer’s disease diagnoses in the United States are determined by clinical examination. That may be about to change. The Food and Drug Administration issued its first approval for a fluid biomarker test May 4, greenlighting Fujirebio’s Lumipulse G cerebrospinal fluid Aβ42/40 assay. This approval will enable broad clinical usage and ensure more consistent insurance coverage.
Adding another option for fluid marker testing, Quest Diagnostics, the largest diagnostic company in the world, announced May 2 that it plans to market a plasma Aβ assay in the United States. Quest AD-Detect will join C2N Diagnostics’ Precivity AD assay as the only blood tests certified for clinical use in the United States, though these tests are not yet FDA-approved or covered by insurance.
- The FDA approved the first CSF AD test, Fujirebio’s Aβ42/40 assay.
- Quest Diagnostics will offer a plasma Aβ assay nationwide.
- Primary care physicians want training on how to use these tests in clinical practice.
Researchers hailed these advances. “The approval of a CSF test is an important first step for fluid biomarkers. The rigorous FDA evaluation gives it a quality stamp,” Henrik Zetterberg at the University of Gothenburg, Sweden, told Alzforum. Meanwhile, Michelle Mielke at Wake Forest University in Winston-Salem, North Carolina, noted that blood-based biomarkers will facilitate more widespread AD screening, particularly in rural areas where PET imaging or CSF testing may not be available.
Nonetheless, researchers cautioned that primary-care physicians will need training to properly interpret Aβ biomarker test results, which can aid diagnosis but by themselves do not indicate the presence of disease. Importantly, all these fluid biomarker tests are intended for use in people with cognitive impairment, not for detecting preclinical disease in cognitively healthy people. Researchers also noted the need for more data on how the tests perform in diverse populations and in people with comorbidities, which are more common in routine clinical care than in research studies. “It’s very important that we understand how best to interpret these markers for clinical practice,” Mielke said.
Read the full article on the Alz Forum website – https://www.alzforum.org/news/community-news/fda-approves-fujirebios-csf-test-ad-quest-diagnostic-offers-plasma-test