Alzheimer's Blood Test Developer in Spotlight After FDA Nod for Aducanumab

Biogen's first beta-amyloid-targeted Alzheimer's disease treatment, aducanumab, obtained the marketing license in the U.S. Still, it will take some time before commercialization due to high drug costs and difficulties in diagnostic testing, observers said.

The FDA approval for aducanumab put a Korean company in the spotlight because it developed a simple beta-amyloid blood test that could detect Alzheimer's early.

Biogen's Aduhelm (aducanumab) won FDA approval as the treatment for Alzheimer's disease.

The FDA granted conditional approval for aducanumab for the treatment of Alzheimer's on Monday. The annual cost of aducanumab therapy has been set at $56,000.

Aducanumab is administered once a month. Its price is deemed quite high because it costs about $4,667 per administration. As soon as Biogen disclosed the price of aducanumab, the U.S. media started to criticize it.

Evaluate Vantage, a U.S. media, compared aducanumab's price with that of Gilead's hepatitis C treatment Sovaldi (ingredient: sofosbuvir), priced at $84,000. Both drugs are surprisingly expensive, but Sovaldi was a cure, whereas aducanumab's benefits were controversial, the news report said.

Experts said that although aducanumab was the first to prove the beta-amyloid theory, the theory was only one of the many presumptions for Alzheimer's disease and that the beta-amyloid clearing effect was only a surrogate marker.

Aducanumab's therapeutic effect can be anticipated in patients with a confirmed accumulation of beta-amyloid in the brain. However, diagnosing it is already difficult, and there are many challenges before the commercialization of the treatment, experts said.

The standard test for diagnosing amyloid plaques is a positron emission tomography (PET) scan, which is time-consuming and costly.

For the commercialization of aducanumab, there should be a simpler and cheaper method to diagnose beta-amyloid accumulation, news reports said.

In Korea, a company developed a simple blood test to detect beta-amyloid accumulation as sensitive as a PET test.

PeopleBio said it identified the relationship between the level of amyloid-beta oligomer (OAβ) in the blood and neurocognitive function and developed a simple blood test diagnosing early Alzheimer's.

Collaborating with several hospitals, including Seoul National University Hospital Healthcare System Gangnam Center, the company is running the early dementia screening. PeopleBio's method costs only one-tenth of the conventional diagnosing of Alzheimer's, according to the company.

In July, a joint research team of Park Kyung-il, a professor at the Department of Neurology of Seoul National University Hospital Healthcare System Gangnam Center, and PeopleBio released the correlation analysis results of amyloid-beta blood testing and the cognitive assessments for Alzheimer's disease in Diagnostics, a journal published by Multidisciplinary Digital Publishing Lab.

PeopleBio is also working on a diagnostic kit to measure abnormal levels of tau, deemed as another cause for Alzheimer's.