Analysts at BMO Capital Markets said in a weekend note that a non-invasive blood test could help boost uptake of Alzheimer’s disease therapies.
The FDA approved the first blood-based diagnostic device that can facilitate the early detection of Alzheimer’s on Friday. The system detects amyloid plaques in older adults showing signs and symptoms of the disease.
In a note to investors on Friday, analysts at BMO Capital Markets said the approval of this new diagnostic test, dubbed the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, “potentially serves as a tailwind” to two commercial anti-amyloid Alzheimer’s therapies that have “struggled to gain traction” in the market—Biogen and Eisai’s Leqembi and Eli Lilly’s Kisunla. The Lumipulse is manufactured by the Tokyo-based in-vitro diagnostics company Fujirebio Diagnostics.
“Not a sea change, but today’s announcement could start to help these franchises gain some more momentum,” BMO wrote.
The Lumipulse works by measuring the levels of two proteins in the blood: pTau217 and ß-Amyloid 1-42. The ratio of these two molecules, as per the FDA’s release, “can reliably predict the presence or absence of amyloid pathology associated with Alzheimer’s disease.” The device, in turn, reduces “the need for a PET scan,” which is currently the standard method of detecting amyloid plaques but can be costly and time-consuming.
In a clinical trial of 499 patients with cognitive impairment, 91.7% of those who tested positive on the Lumipulse test indeed showed amyloid plaques as assessed by a PET scan or by a similar diagnostic test that used cerebrospinal fluid (CSF) instead of blood. Meanwhile, 97.3% of patients who tested negative on the Lumipulse also showed negative results in the PET or CSF tests.
According to the FDA, the main risks associated with the Lumipulse are the possibility of false negative and false positive results, which could lead to improper medical management.
Mizuho Securities analysts pointed to this risk in a note to investors Monday morning. “We still need details on reimbursement and exactly how physicians will use it, given the noted risk of false positives and negatives,” they wrote.
In an emailed statement to BioSpace, Howard Fillit, chief scientific officer at the Alzheimer’s Drug Discovery Foundation, called the approval of the Lumipulse a “major milestone for patients and clinicians,” especially at a time when “the number of people developing [Alzheimer’s] continues to increase exponentially.”
Lumipulse is a “game changer,” Fillit continued, noting that a simple and convenient blood test would allow “more patients to receive treatment options that have the potential to significantly slow or even prevent the disease.”
Alzheimer’s disease drug developers have had trouble securing a stable foothold in the market. Eisai, which co-owns Leqembi with Biogen, announced in March that it would again be lowering its sales forecast for the anti-amyloid antibody because of the “delayed uptake in the US market.” For Eisai’s fiscal year 2027, which ends in March 2028, the company expects Leqembi to make ¥250 billion to ¥280 billion ($1.7 billion to $1.9 billion USD)—roughly a 50% drop from its prior forecast in March 2024 of around ¥500 billion ($3.45 billion USD).
Eli Lilly’s Kisunla has also struggled. According to a report from Jefferies earlier this month, the drug sold $10.1 million in April, a 22% month-on-month growth from its $8.3 million earnings in March.
