Fda Oks New Blood Test Used To Diagnose Alzheimer’s Disease

The U.S. Food and Drug Administration (FDA) has cleared for marketing what it is calling the first blood test for diagnosing Alzheimer’s disease.

The test from Fujirebio Diagnostics, Inc. and branded as “Lumipulse” was found to reliably predict the presence or absence of amyloid pathology associated with Alzheimer’s disease during a study with 499 patients, according to a FDA press release.

The requires a blood draw, which the FDA noted is “less invasive and much easier” than the traditional method of checking for Alzheimer’s, a spinal tap.

“Nearly 7 million Americans are living with Alzheimer’s disease and this number is projected to rise to nearly 13 million,” Michelle Tarver, Center for Devices and Radiological Health director, said in the release. “Today’s clearance is an important step for Alzheimer’s disease diagnosis, making it easier and potentially more accessible for U.S. patients earlier in the disease.”

The test is meant to be used for patients presenting Alzheimer’s disease symptoms in specialized care settings such as memory care. Senior living operators could use such tests to diagnose and treat residents living with cognitive issues earlier in their disease progression.

“Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined,” FDA Commissioner Martin Makarym, said in the release. “Knowing that 10% of people aged 65 and older have Alzheimer’s, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients.”

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