First Blood Test To Diagnose Alzheimer’s Disease Comes In The Market For Sale Without FDA Approval

A company, which has developed the first blood test to detect the onset of Alzheimer’s disease, has started selling it in the market. This new blood test will help in quick diagnosis and treatment of the disease. However, this blood test has not been approved by the US Food and Drug Administration (FDA). It has raised many concerns about the safety and efficiency of this new diagnostic test. Many experts are doubtful about the findings of the clinical trial of this blood test, which have not been approved by the federal body. This is being sold under the general guidelines for commercial labs. Nevertheless, these experts agree that a simple blood test to diagnose dementia is required in clinics. As per the data, more than 5 million people are dealing with dementia in the US. At the same time, many millions of people around the globe have been suffering from the disease. People need to have a certain set of symptoms to be diagnosed with the disease through this test such as memory loss and buildup of protein in the brain.

People need to undergo a PET scan to measure the build-up of a protein called beta-amyloid in the brain. PET scan is usually not covered by medical insurance. Due to financial issues, most people do not go through PET scans and keep wondering if they have symptoms due to aging, Alzheimer’s, or some other reasons. This blood test has been developed by C2N diagnostics of St. Louis, which aims to bridge the gap. The founders of the company include Drs. David Holtzman and Randall Bateman from Washington University School of Medicine, who has led the research for the blood test as well. This test does not conduct a diagnosis on people without symptoms. It includes people who are 60 years and above and have thinking issues and are being observed for possible Alzheimer’s disease. This test is not covered by insurance or Medicare. It costs around $1250. The company offers discounts as well based on people’s income. Only doctors can prescribe this test, which takes at least 10 days to deliver results. It has been cleared for sale in a few states of the US and Europe.

The first blood test for diagnosis of Alzheimer’s detects two types of amyloid particles along with various forms of a protein, which shows whether a person has a gene, which shoots up the risk of the disease. These factors have been merged in a formula, which includes age, and patients are given a score hinting low, medium, or high possibility of having amyloid buildup in the brain. The lead author of the study has said that if the test keeps the patients in a low category, it means that there is a need for detecting other things besides Alzheimer’s disease. As per the experts, there are many reasons, which can cause cognitive impairment in people such as the effects of medications and vitamin deficiencies. Experts have said that the diagnosis method is not different from other screenings, which have now. The only difference is that it is a blood test rather than a brain scan. The officials of the company have said that the blood test has been proved to be effective in 92 percent of cases and it has missed 8 percent of cases. However, experts have not published the efficacy data of the blood test from the clinical trial. Although doctors have released the findings of research on amyloid buildup, which has led to the discovery of the blood test. In the meantime, the officials have said that they will proceed with the approval of the FDA as well.