Imagine the excitement! On August 24, 2026, Roche announced FDA clearance of the first and only single-biomarker blood test that supports both rule-in and rule-out assessment of amyloid pathology. This could represent an important step forward in Alzheimer’s disease diagnosis for people age 55 and older who are experiencing signs, symptoms, or complaints of cognitive decline. English please! Simply put, a blood test can now help healthcare providers determine whether amyloid pathology associated with Alzheimer’s disease may be present.

The new Elecsys pTau217 blood test is designed for use in both primary and specialty care settings. According to Roche’s announcement about the FDA clearance, the test can be used across more than 4,500 Roche cobas laboratory instruments in the United States. That means testing may become available in more settings instead of being limited primarily to specialty centers.

Why is this so important? According to Roche, an estimated 75% of people living with dementia remain undiagnosed. Those who are diagnosed may experience years of uncertainty after symptoms first appear. Traditional approaches for assessing Alzheimer’s disease can also be costly, invasive, or difficult to access. A blood test that can support Alzheimer’s disease diagnosis could help more people get answers sooner.

Of course, this test is not intended as a screening test for people without symptoms. It is designed to be used along with other clinical information when evaluating people experiencing cognitive decline. Still, this is an exciting milestone!

A big shout-out to the researchers who never give up because “failure is not an option”! Congratulations, and may the world benefit from this great science!

Stay well and stay informed!