New spinal fluid test for Alzheimer’s disease approved by US-FDA
An Alzheimer’s disease (AD) diagnostic test that can effectively detect levels of amyloid protein aggregations in cerebrospinal fluid has been approved for use by the US Food and Drug Administration (FDA). The new “Lumipulse” test is the first to make amyloid measurements more accessible to patients as opposed to expensive positron emission tomography (PET) scans, the only diagnostic tool available to detect markers of AD.
The FDA has indicated that the Lumipulse test is only intended for adults aged over 55 years who are being evaluated by a doctor for AD. The test is not to be used as a general screening tool but can instead help doctors rule out early-onset Alzheimer’s in patients presenting with neurological problems.
“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 AD diagnosis,” said Jeff Shuren, Director of Devices and Radiological health, FDA.
“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 AD,” Shuren added.
Meanwhile, Dr. William Hu, Chief, Division of Cognitive Neurology at Robert Wood Johnson Medical School, New Jersey, said, “The development of accurate tests for AD using biomarkers found in the cerebrospinal fluid or other bodily fluids is a requirement if we are to make real progress against this dreaded disease.
“FDA authorisation of the Lumipulse test is a significant advance that [facilitates] more efficient clinical trials for new AD therapies and [enables] patients and their doctors to make more informed decisions and take action much earlier in the disease process.”
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