May 16, 2025 – The United States Food and Drug Administration (FDA) has approved Fujirebio Diagnostics’ Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio test for diagnosing Alzheimer’s disease. It is the first-ever in vitro diagnostic blood test authorized in the United States to assist in diagnosing Alzheimer’s disease.
Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test was developed to enable early detection of amyloid plaques linked to Alzheimer’s disease in adult patients. This approval could revolutionize Alzheimer’s care by enabling timely intervention as well as improving patient outcomes.
Blood tests have become vital tools for early diagnosis and timely interventions in complex diseases like Alzheimer’s. They are also cost-efficient and more convenient than traditional tests. As a result, companies like Fujirebio are constantly focusing on developing innovative blood tests.
In the words of Martin A. Makary, FDA Commissioner, “Alzheimer’s disease affects more people than prostate and breast cancer combined. Knowing that 10% of people aged 65 and older are affected by Alzheimer's—and that this number is projected to double by 2050—I remain hopeful that innovative medical products like this will offer meaningful help to patients.”
Fujirebio’s Lumipulse test analyzes two proteins, β-amyloid 1-42 and pTau217, present in human plasma and calculates their numerical ratio. This ratio is linked to the presence or absence of amyloid plaques in patient’s brain, thereby eliminating the need for PET scans for diagnosis.
Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test only requires a simple blood draw for diagnosing the disease. This makes it less invasive as well as significantly easier for patients to access. Development and approval of such novel tests will play a key role in the expansion of Alzheimer’s disease diagnostics industry.
According to Coherent Market Insights (CMI), the global Alzheimer’s disease diagnostics and therapeutics market size is projected to expand from USD 7,295.9 in 2025 and USD 10,543 Mn by 2032. Global demand for Alzheimer’s disease diagnostic and therapeutic products will likely surge at a CAGR of 5.4% during the forecast period.
“Early diagnosis can make a huge difference for people suffering from Alzheimer’s disease. Thus, development and approval of novel blood tests, such as Fujirebio’s Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio test, will play a key role in enhancing Alzheimer’s care,” says a senior analyst at CMI.”
Innovative blood tests like Fujirebio’s Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio offer less invasive and more accessible alternatives to traditional diagnostic methods. They have the tendency to improve early detection and management of Alzheimer’s disease.
The approval of Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio could encourage other pharmaceutical companies to also develop novel blood tests for complex diseases. They will also focus on expediting the approval process to bring these therapies to market more quickly and gain a competitive edge.
Sources:
News Outlet: Reuters
U.S. Federal Agency: FDA