Quest Diagnostics launches Alzheimer’s blood test for consumers

CHICAGO, July 31 (Reuters) – Quest Diagnostics (DGX.N) launched the first direct-to-consumer blood test on Monday to detect abnormal levels of beta amyloid, a key Alzheimer’s disease protein that can appear years before dementia symptoms emerge.

The $399 test, called AD-Detect, uses the same technology as a blood test the company began selling for use by doctors in early 2022.

“One of the advantages of having an amyloid test is that it lets you know, potentially years in advance of even symptoms, that you are at risk for Alzheimer’s,” said Dr. Michael Racke, Quest’s medical director of neurology.

The ad follows US regulatory approval earlier this month of Leqembi, an Eisai drug (4523.T) and partner Biogen (BIIB.O) It removes amyloid from the brain and has been shown to slow the progression of Alzheimer’s disease in early-stage patients.

A similar treatment from Eli Lilly (LLY.N) called donanemab is under review by the US Food and Drug Administration.

Previous Alzheimer’s disease treatments have treated the symptoms, but did not address the underlying disease.

Quest’s consumer test is aimed at adults 18 and older who may have mild memory loss or a family history of Alzheimer’s and want to understand their own risk for the disease, Racke said.

Users must first pay for the trial on the Quest website. A telemedicine physician will review the purchase to ensure it is medically necessary and place an order on her behalf. Patients can review their results online and have the option to speak with a doctor at no additional cost.

If the test is positive, a doctor from an independent doctor network will automatically contact people to discuss next steps and potentially share the results with other doctors, the company said.

Dr. Sarah Kremen, a neurologist at Cedars-Sinai in Los Angeles, was concerned that people who test positive but have no symptoms will seek further testing, possibly in the hope of accessing new treatments. But they won’t qualify for further testing if they aren’t symptomatic.

Racke said those people may still benefit from lifestyle interventions, such as diet and exercise, to reduce their risk or delay the onset of symptoms. They may also qualify for Alzheimer’s trials that study treatments in people at risk who are still cognitively normal.

The Quest lab-developed test, created and performed in a single lab, has not gone through any FDA review. The agency generally does not review such tests as long as they are prescribed by a health care provider.

Reporting by Julie Steenhuysen; Edited by Richard Chang and Bill Berkrot

Our standards: The Thomson Reuters Trust Principles.