(RxWiki News) The US Food and Drug Administration (FDA) has approved a first-of-its-kind test to diagnose Alzheimer’s disease.
This test is called the Lumipulse G β-Amyloid Ratio (1-42/1-40) test. The FDA approved it for use in those for whom all of the following points are true:
- 55 years and older
- Under evaluation for Alzheimer’s disease and other causes of cognitive decline
- Presenting with cognitive impairment
The Lumipulse test looks for amyloid plaques, which are typically seen with Alzheimer’s disease.
"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,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a press release. “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."
This test is a new diagnostic testing option for the estimated 6 million Americans who may have dementia caused by Alzheimer’s disease. Alzheimer’s disease gets worse over time, so early and accurate diagnosis is important. An early diagnosis can help patients and caregivers plan and receive treatment options earlier.
Before this new FDA approval, the only test used to detect amyloid plaques was a positron emission tomography (PET) scan.
The Lumipulse test measures the ratio of specific proteins that can accumulate and form plaques, which can help doctors determine whether a patient is likely to have amyloid plaques, a hallmark sign of Alzheimer’s disease.
A positive Lumipulse test result means amyloid plaques are present. Patients with other types of neurologic conditions could also test positive with this test, the FDA noted.
Like many diagnostic tests, Lumipulse may present a risk of false negative and false positive results:
- A false positive result means your test shows you have a disease, but you don't actually have the disease.
- A false negative result means your test shows you don't have a disease, but you actually do have the disease.
That's part of the reason why this test is not intended as a screening or standalone diagnostic assay. The Lumipulse test is to be used in combination with other tests and evaluations, according to the FDA.
The FDA granted the Lumipulse test Breakthrough Device designation. This means that the test was fast-tracked for approval because it could provide more effective diagnosis of a life-threatening or irreversibly debilitating disease.
The FDA permitted marketing of this test to Fujirebio Diagnostics, Inc.
Speak with your health care provider if you have any questions.