Roche and Lilly Eapp into Alzheimer’s testing

Both Roche and Lilly have so far failed get their therapies for Alzheimer’s on the market. Now they are working together with the aim of diagnosing rather than treating the disease. Today the two announced their development collaboration for the Elecsys Amyloid Plasma Panel, intended to help healthcare professionals diagnose patients more quickly. As a blood test this could offer advantages over the current FDA-cleared technologies – two of which are sold by Roche – which detect either amyloid or tau in cerebrospinal fluid samples. Despite its name the test does not use amyloid as its biomarker; instead it measures levels of phosphorylated tau and apolipoprotein E4. Elevations in the former occur in early stages of Alzheimer’s, while ApoE4 is the most common genetic risk factor for the disease. Roche told Evaluate Vantage that its research team tested a number of potential biomarkers and these were the most promising at indicating increased amyloid-beta levels in a patient’s brain.

Selected IVDs for Alzheimer's disease
Company Test Biomarker Sample Status
The three FDA-cleared tests…
Fujirebio
(HU Group)
Lumipulse G β-Amyloid Ratio Amyloid beta 42/40 ratio CSF Granted de novo clearance Apr 2022
Roche Elecsys β-Amyloid (1-42) CSF II Amyloid beta 1-42 CSF Granted 510(k) clearance Dec 2022
Roche Elecsys Phospho-Tau (181P) CSF Phosphorylated tau 181 CSF Granted 510(k) clearance Dec 2022
And Roche and Lilly's other assays…
Roche/Lilly Elecsys Amyloid Plasma Panel (Eapp) Phosphorylated tau 181 and apolipoprotein E4 Blood In development
Lilly P-tau217 test Phosphorylated tau 217 Blood Used in-house to aid trials of Alzheimer's drugs
Source: Evaluate Medtech & company releases.

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