The Food and Drug Administration (FDA) has approved a new blood test developed by Roche and Eli Lilly to help identify signs of Alzheimer’s disease in individuals aged 55 and older. This test, known as Elecsys pTau217, marks a significant shift from traditional diagnostic methods such as spinal taps or PET scans, which are often invasive and costly. The test is designed to detect amyloid, a protein associated with Alzheimer’s, providing results that indicate whether a person is likely to have the disease.
Already approved for use in Europe, the test can be conducted on more than 4,500 Roche lab analyzers across the United States. According to a report by Reuters, Labcorp and Quest Diagnostics have announced plans to offer the test through their networks, significantly expanding its accessibility.
While the test is not a standalone diagnostic tool, it is intended to complement existing clinical information, providing a more accessible and less invasive option for early detection. As Chris Stamatkin from Roche U.S. Medical Affairs stated, “This is one more tool in the toolbox that allows us to really get a diagnosis earlier on for these patients.”
The approval comes at a critical time, as new therapies for Alzheimer’s are emerging that can slow the disease’s progression if administered early. The Centers for Disease Control and Prevention (CDC) reports that 6.7 million older adults in the U.S. are living with diagnosed Alzheimer’s, a number expected to double by 2060. However, many cases remain undiagnosed, highlighting the importance of early detection tools like this blood test.
Forbes reports that the test’s integration into existing laboratory workflows is seamless, requiring no additional equipment purchases. This development represents a significant advancement in the fight against Alzheimer’s, offering hope for earlier diagnosis and intervention.