US FDA clears first blood test to diagnose Alzheimer's disease
In a breakthrough, the United States Food and Drug Administration gave clearance to the first blood test that can help in diagnosing Alzheimer’s disease.
Alzheimer's disease, a brain disorder, has plagued nearly 7 million Americans, and experts have projected the number to rise to nearly 13 million in the country. The condition makes it difficult for the individual to carry out their daily chores as it slowly destroys the memory and thinking skills.
As per the FDA, the test called Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is for the early detection of amyloid plaques associated with Alzheimer’s disease in adult patients, aged 55 years and older, exhibiting signs and symptoms of the disease.
Amyloid plaques in an individual's brain are a sign of the condition. While these plaques can appear in other diseases, the identification of the plaques along with other evaluations helps doctors in the understanding of the condition.
The usual process of diagnosing Alzheimer's disease involves the patient going through a positron emission tomography (PET) brain scan to identify the plaques. However, these scans are costly, time-consuming, and harmful to the patients are they are exposed to radiation.
About the blood test
The newly cleared blood test measures two proteins, pTau217 and β-amyloid 1-42, found in human plasma and calculates the numerical ratio of the levels of the two proteins.
This ratio is then correlated to the presence or absence of amyloid plaques in the patient’s brain, reducing the need for a PET scan.
In the clinical study, 91.7% of individuals who tested positive with the blood test had the presence of amyloid plaques by PET scan or CSF test result, and 97.3 % of individuals with negative results had a negative amyloid PET scan or CSF test result.
"These findings indicate that the new blood test can reliably predict the presence or absence of amyloid pathology associated with Alzheimer’s disease at the time of the test in patients who are cognitively impaired. The test is intended for patients presenting at a specialized care setting with signs and symptoms of cognitive decline. The results must be interpreted in conjunction with other patient clinical information," informed FDA.
Health