The U.S. Food and Drug Administration (FDA) has approved a new blood test that may help doctors figure out if a person’s memory problems are related to Alzheimer’s disease.
The test is called Elecsys pTau181 and was developed by Roche Diagnostics in partnership with Eli Lilly. It is meant for adults 55 and older who are beginning to show signs of memory loss or cognitive decline.
The Elecsys test looks for a protein in the blood called pTau181. When levels of this protein are high, it may be a sign of Alzheimer’s or other brain-related conditions.
In a recent study with 312 people, the test correctly ruled out Alzheimer’s in nearly 98% of cases. This means that if someone’s test result is negative, there is a very high chance they do not have Alzheimer’s.
According to Laura Parnas from Roche Diagnostics, a negative result gives strong reassurance that Alzheimer’s is unlikely to be the cause of the memory problems. However, she also emphasized that a positive test result doesn’t confirm the disease. Instead, it means that further tests—like brain scans or spinal fluid tests—are still needed to make a final diagnosis.
Brad Moore, president and CEO of Roche Diagnostics North America, said that making Alzheimer’s testing more accessible through simple blood tests could help doctors and patients get answers more quickly. This could allow for earlier support and treatment.
This is the second Alzheimer’s blood test approved by the FDA in 2024. Earlier in the year, the FDA approved a test called Lumipulse from a company called Fujirebio. That test measures a different set of proteins related to Alzheimer’s.
Experts believe having more than one testing option is a good thing. Dr. Richard Isaacson, a neurologist and Alzheimer’s researcher, explained that testing for Alzheimer’s is complex and shouldn’t rely on a single marker.
He said he always orders a panel of tests to get a clearer picture of a person’s brain health and to track changes over time. He also stressed that these tests are still new, and doctors are still learning how to use them in practice.
Dr. Isaacson warned that although the new blood tests are promising, doctors should be cautious. False positives could lead to unnecessary worry or treatments, so test results should always be considered alongside other medical information.
Despite the need for caution, Alzheimer’s experts view this approval as a big step forward. Joanne Pike, president and CEO of the Alzheimer’s Association, said the Elecsys test can help doctors quickly rule out Alzheimer’s in some patients.
This would allow people with other causes of memory loss to get help sooner and make sure those who may have Alzheimer’s get referred for more accurate testing and early treatment.
Roche says the Elecsys test will be available through its existing network of about 4,500 lab machines across the United States.
In summary, this new test offers a helpful new tool for doctors to evaluate memory loss more efficiently. While it’s not a final answer on its own, it could speed up the process of diagnosing Alzheimer’s and getting patients the right care.
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