Elecsys’ approval could help boost the uptake of currently approved Alzheimer’s disease therapies, including Biogen’s Eisai-partnered Leqembi, with CEO Chris Viehbacher recently noting that such biomarker-based tests could “remove some of the bottlenecks” in uptake.
The FDA has given the go-ahead to Roche and Eli Lilly’s blood-based test to aid the initial assessment of cognitive decline in Alzheimer’s disease. The Elecsys pTau181 test is the only one of its kind approved for use in the primary care setting.
Elecsys is now indicated for patients 55 years and older who show signs or complain of cognitive decline, according to Roche’s Sunday press release. The test, which measures blood levels of the phosphorylated Tau (pTau) 181 protein, can help primary care providers rule out Alzheimer’s disease-related pathology in patients with cognitive decline, though its results “should be interpreted in conjunction with other clinical information,” the companies said.
Elecsys’ approval could help boost the uptake of currently approved Alzheimer’s disease therapies, which have largely struggled to gain a footing in the market. During its second quarter 2025 report, Biogen CEO Chris Viehbacher specifically pointed to these biomarker tests as a potential catalyst to improve Leqembi’s market position. Such tests, he told investors, could “remove some of the bottlenecks in the system.”
Data from more than 300 patients supported Sunday’s approval, demonstrating that Elecsys had a 97.9% negative predictive value at ruling out Alzheimer’s pathology. Roche and Lilly collaborated on Elecsys under a March 2023 partnership aimed at the earlier detection of Alzheimer’s disease.
Elecsys is not the first blood test for Alzheimer’s disease. That came in May this year when the FDA approved Fujirebio Diagnostics’ Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, also indicated for use in patients 55 years and older. As in the case of Roche’s test, Lumipulse must also be used alongside other clinical assessments, the regulator said.
However, Lumipulse’s use is limited to patients who present in a specialized care setting, whereas Roche’s Elecsys can be administered by primary care physicians. This earlier availability, the pharma said, can “significantly broaden” access to minimally invasive testing. In turn, primary care doctors can also “guide appropriate referrals,” allowing neurologists to “focus on the patients most likely to need advanced evaluation and treatment.”
The Alzheimer’s space has been on a regulatory winning streak lately, including an approval for Biogen and Eisai’s subcutaneous Leqembi last month. The under-the-skin injection, branded Leqembi Iqlik, is indicated as a maintenance therapy for patients who have been on intravenous Leqembi for at least 18 months. The companies are looking to file for approval for Leqembi Iqlik as an induction option next year.
In July, Lilly’s anti-amyloid therapy Kisunla secured a label expansion for a more gradual dosing schedule, which the pharma says could ease the risk of amyloid-related imaging abnormalities. Kisunla was first approved in July 2024, about a year and a half behind Leqembi. Recent data established the long-term efficacy of Kisunla, which can keep amyloid plaques at bay for up to 2.5 years.
