St. Louis-based company C2N Diagnostics has begun selling the first blood test to help diagnose Alzheimer’s disease.

The test has not yet been approved by the U.S. Food and Drug Administration, but it is considered by experts to be a monumental leap in the medical field by making it much easier for individuals to learn whether they have dementia.

An estimated fifty million people worldwide have dementia, and there are nearly ten million new cases every year. Alzheimer’s disease is the most common form of dementia and contributes to about 60 percent to 70 percent of all cases, according to the World Health Organization. In the United States, more than five million people have been diagnosed with Alzheimer’s.

Most patients are known to have symptoms like memory loss in addition to evidence of a buildup of a protein called beta-amyloid in the brain.

Currently, the best way to measure the protein is a highly expensive PET brain scan that usually is not covered by health insurance. In many instances, those who can’t afford the scan are left to wonder if their problems are due to normal aging or some form of dementia.

That’s where C2N Diagnostics comes in. Although not intended for general screening or for people without symptoms, the company’s test is able to measure amyloid particles as well as forms of a protein indicating increased genetic risk for the disease. It then combines these data with other factors, such as the patient’s age, to determine the risk of amyloid buildup in the brain. 

The diagnostic test, which is sold in all but a few states and was recently cleared for purchases in Europe, is intended for individuals sixty or older who have experienced cognitive problems and are being evaluated for Alzheimer’s.

The company charges $1,250, and it’s not covered by insurance or Medicare—although discounts based on income are available. Only doctors can order the test, and the results are expected to be available within ten days.  

If the test places the individual in the low category, then “it’s a strong reason to look for other things” besides Alzheimer’s, Dr. Randall Bateman, of Washington University School of Medicine, who headed the research that led to the test, told the Associated Press.  

“There are a thousand things that can cause someone to be cognitively impaired,” from vitamin deficiencies to medications, C2N Diagnostics founder Dr. David Holtzman told the Associated Press. 

“I don’t think this is any different than the testing we do now” except it’s from a blood test rather than a brain scan. “And those are not 100 percent accurate either,” he added.  

The company, however, has yet to publish any data on the test’s accuracy but is still moving ahead with the process of seeking FDA approval.  

Ethen Kim Lieser is a Minneapolis-based Science and Tech Editor who has held posts at Google, The Korea Herald, Lincoln Journal Star, AsianWeek, and Arirang TV. Follow or contact him on LinkedIn.