FDA Approves First Blood Test for Early Detection of Alzheimers

FDA

Prime Highlights

  • The FDA approved the first blood test to detect Alzheimer’s, Lumipulse, to diagnose less invasively and earlier.
  • The test quantitates some blood protein ratios that are linked to amyloid plaques—indicators of Alzheimer’s.

Key Facts

  • Lumipulse is a test to quantify the ratio of amyloid beta proteins in blood, which is a principal marker to diagnose Alzheimer’s.
  • Indicated for adults aged 55 and older for use with cognitive symptoms, the test should be used along with clinical evaluation.

Key Background:

In a first in the diagnosis of Alzheimer’s, the United States Food and Drug Administration (FDA) has approved the use of Lumipulse, the first of its kind to an Alzheimer’s disease blood test. The test, created by Fujirebio Diagnostics, measures the concentration ratio of two amyloid beta proteins in the blood. The result is shown to be linked with amyloid plaque deposition in the brain, one of the features of Alzheimer pathology.

Alzheimer’s used to be costly and involved invasive testing such as spinal taps or PET scans, out of reach to the masses at the first stage. Lumipulse testing is less expensive and less invasive and will be a godsend for family doctors and outpatient centers. This is a bound forward in bounds in more equitable and earlier diagnosis.

The test is approved for use in subjects older than 55 years old and subjects with dementia or mild cognitive impairment. The test should never be given to symptom-free patients since the risk of false positives or false negatives may lead to false diagnosis. Surprisingly, the FDA has also demanded that results from Lumipulse are interpreted against the backdrop of a total clinical evaluation so that errors are avoided and appropriate treatment planning is provided.

Alzheimer’s disease is already widespread among over 7 million American elderly, a figure destined to double by 2050. Knowing the current treatment for Alzheimer’s disease is provided as anti-amyloid drugs like lecanemab and donanemab, earlier than ever identification is crucial. These drugs attempt to replicate or block declining mental ability but are most effective when given early in the illness.

While Lumipulse won’t replace diagnosis, it’s a better addition to Alzheimer’s diagnostic arsenal at this point. Expanding availability of the test and treating patients sooner, this blood test should be able to reverse the tide of disease and improve patient outcomes.

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