Alzheimer's disease is currently diagnosed with invasive methods that require expensive medical imaging or require spinal faucets. Now patients have another option. The FDA cleared a new Fujirebio diagnostic test that detects signs of the disease from a patient's blood sample, marking what the agency calls a neurodegenerative disease.
The regulatory decision announced Friday covers early detection of amyloid plaques in adults aged 55 and older, which exhibit signs and symptoms of the disease. Diagnosis will be accompanied by the brand name Lumipulse G PTAU217/ß-amyloid 1-42 plasma ratio.
The accumulation of amyloid plaque is a hallmark of Alzheimer's disease. New FDA-approved Alzheimer's drug Leqembi from Eisai and Kisunla from Eli Lilly work by targeting and breaking down amyloid plaques. The ability to detect signs of disease early can enable patients to start treatment early.
Fujirebio's test measured plasma levels of PTAU217 and β-amyloid 1-42 of both proteins. The test then calculated the numerical ratio of these protein levels, which correlated with the presence of amyloid plaques in the patient's brain.
The FDA's decision to the new Fujirebio diagnosis is based on the results of clinical tests of 499 plasma samples in cognitively impaired adults. The FDA said that 91.7% of the starch-boiled plaques in people who passed the Fujibio test were present in positron emission tomography (PET) scan or cerebrospinal fluid (CSF) test results; 97.3% of the negative results were negative for PET scan or CSF test results. Like any diagnostic test, the FDA said the main risk of the test is the possibility of false positive or false negative results.
Fujirebio has sold an Alzheimer's test that measures the proteins from CSF samples. The test is a predicate device that compares the new Fujirebio diagnostics based on the FDA's 510(k) pathway. The FDA found that the new Lumipulse test was essentially equivalent to previous tests analyzing CSF.
“Today's clearance is an important step in the diagnosis of Alzheimer's disease, making it easier and possibly easier for U.S. patients to access the disease earlier,” Michelle Tarver, director of the FDA's Center for Equipment and Radiation Health, said in the agency's announcement of regulatory decision.
Leerink Partners estimates that the market for Alzheimer's diagnosis totals about $9 billion. But analyst Puneet Souda pointed out in his Friday study that the intake of Alzheimer's drugs is small, which has the effect of limiting the trajectory of diagnostic demand. Other companies that develop blood-based diagnosis include C2N Diagnostics, Beckman Coulter Diagnostics and Quanterix. With the first FDA clearance, Fujirebio's new diagnosis sets the benchmark for other blood tests, Souda said. However, as competition in this market rises, differentiation may depend on the data shown in clinical tests.
“Ultimately, we think most of the assays of clinical evidence will win the game – so far, it seems like C2N PercitivityAd2.”
Photo by FDA
