Alzheimer’s blood test gets FDA breakthrough device designation

Test detects tau protein, predicting risk in people with cognitive decline

Margarida Maia, PhD avatar

by Margarida Maia, PhD |

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The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to Quanterix’s experimental blood test measuring p-Tau 217, the protein that builds up as toxic tangles in the brains of people with Alzheimer’s disease.

The test, Simoa p-Tau 217, has the potential to help doctors diagnose Alzheimer’s in people with cognitive decline before the patients show outward signs of the disease. Alzheimer’s begins with the buildup of proteins, which can be detected via imaging tests before symptoms such as memory loss and disorientation appear.

“Early detection is crucial in shaping effective care strategies and improving patient outcomes,” Masoud Toloue, PhD, CEO of Quanterix, said in a company press release. “The FDA’s decision to grant breakthrough device designation further validates the importance of accessible, non-invasive p-Tau 217 testing.”

Beta-amyloid plaques and tau tangles in the brain are two hallmarks of Alzheimer’s. Buildup of these proteins can be measured using brain scans and in cerebrospinal fluid (CSF), the fluid found within the tissue that surrounds the brain and spinal cord.

Because these approaches are expensive and invasive, researchers have been working to develop cheaper and less invasive tests that could measure beta-amyloid and tau buildup in the blood and allow for a more accurate Alzheimer’s diagnosis.

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People with Alzheimer’s have high levels of p-Tau 217  in their blood. Research has shown that measuring p-Tau 217 in the blood may work just as well, or better, than FDA-approved CSF tests for Alzheimer’s.

Quanterix uses its Simoa technology to measure p-Tau 217 in blood samples. The antibody-based technology has been able to detect higher levels of p-Tau 217 in people who were highly likely to have Alzheimer’s.

Simoa p-Tau 217 isn’t designed as a stand-alone diagnostic test, but could be used alongside other tests to get a complete picture of a patient’s biomarkers before diagnosis.

FDA breakthrough device designation, given to devices that may offer more effective diagnosis of life-threatening or debilitating diseases with an unmet medical need, “is an important step in our strategy to develop a global testing infrastructure for Alzheimer’s,” Toloue said.

The designation comes with benefits aimed at speeding a device’s development and potential approval, including the opportunity for more frequent meetings with the FDA during the development process and priority review for regulatory submissions.