The FDA has approved a lab test for evaluating cognitively impaired adults who may be in the early stages of Alzheimer’s disease.
The test, called Lumipulse for short—full name G β-Amyloid Ratio (1-42/1-40)—is manufactured by Tokyo-headquartered Fujirebio Diagnostics to check cerebrospinal fluid for signs of brain amyloid plaques associated with Alzheimer’s.
Announcing the green light in a video released May 4, Jeff Shuren, MD, JD, head of FDA’s Center for Devices and Radiological Health, expresses hope the test will supplant the current, imaging-based gold standard exam:
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. 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.”
The approval follows FDA’s designation of Lumipulse as a breakthrough device in 2019. Fujirebo, whose U.S. headquarters are in Malvern, Pa., applied for 510(k) premarket clearance in 2020.
In an FDA news release accompanying the May 4 announcement, the agency says it reviewed the device through its De Novo premarket review pathway, which it uses for evaluating new types of medical devices that present low to moderate risk.
“This action creates a new regulatory classification,” FDA notes, “which means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.”
FDA says the risks associated with the Lumipulse device are “mainly the possibility of false positive and false negative test results” and describes deleterious scenarios to which such results might lead.
Observers commenting on the news as reported by Medscape express skepticism over the short list of risks.
“What is the cost of the lumbar puncture [to obtain spinal fluid]?” writes one. “What are the clinical hazards to the patient with this invasive procedure? As an example, the cost of an epidural blood patch or infection and necessary care thereafter? Will someone do the cost analysis for PET and this in vitro test in the same local region by the same operators for the lumbar puncture?”
More coverage of Alzheimer’s diagnostics:
CMS coverage decision for Alzheimer's drug, related PET scans sparks concern in imaging community
CMS finalizes decision to limit coverage for controversial Alzheimer’s drug, related imaging
New PET imaging tracer helps spot signs of Alzheimer’s disease years before symptoms appear
Imaging industry advocate slams feds’ failure to address PET coverage gap in recent ruling
Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.