FDA Permits Marketing for First In Vitro Test for Alzheimer’s Disease

May 17, 2022 - FDA recently permitted the marketing of the first in vitro diagnostic test for the early detection of amyloid plaques associated with Alzheimer’s disease.  

Adult patients aged 55 years and older being evaluated for Alzheimer’s disease and other causes of cognitive decline can use the Lumipulse G  β-Amyloid Ratio (1-42/1-40) test. The test measures the ratio of β-amyloid 1-42 and β-amyloid 1-40 concentrations found in the human cerebral spinal fluid (CSF). 

CFS can help physicians determine whether a patient is likely to have amyloid plaques, a hallmark sign of Alzheimer’s disease. A positive test result is consistent with the presence of amyloid plaques, while a negative result reduces the likelihood that a patient’s cognitive impairment is due to Alzheimer’s disease. 

These results enable physicians to pursue other causes of cognitive decline and dementia, an FDA spokesperson said. And experts may interpret results in conjunction with additional patient clinical information. 

“The availability of an in vitro diagnostic test that can potentially eliminate the need for time-consuming and expensive PET scans is great news for individuals and families concerned with the possibility of an Alzheimer’s disease diagnosis,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in the announcement. 

“With the Lumipulse test, there is a new option that can typically be completed the same day and can give doctors the same information regarding brain amyloid status, without the radiation risk, to help determine if a patient’s cognitive impairment is due to Alzheimer’s disease,” Shuren continued.  

More than six million Americans aged 65 and older may have dementia caused by Alzheimer’s disease, according to the National Institutes of Health. Alzheimer’s disease is a brain disorder known to slowly destroy memory and thinking skills and, eventually, the ability to carry out the simplest tasks.  

In June 2021, FDA approved Biogen’s Aduhelm. This approval was the first for Alzheimer’s in over 20 years and came after long speculation about the drug’s efficacy. 

In 2019, Biogen pulled Aduhelm after some trials showed it may not have much effect, but ultimately reversed course and announced it would submit Aduhelm for approval after all. Then in January 2022, Biogen announced that it will reduce the wholesale acquisition cost of the drug in the US by nearly 50%. 

For a patient of average weight, the annual cost at the maintenance dose will be $28,200.