The presence of APOE genes is associated with a higher risk of developing Alzheimer’s. Image credit: Kateryna Kon / Shutterstock.

Qiagen has partnered with Eli Lilly to develop an in vitro diagnostic (IVD) that can detect apolipoprotein E (APOE) genotypes for diagnosing Alzheimer’s disease.

Qiagen plans to add the APOE genotyping test, QIAstat-Dx IVD panel, to its QIAstat-Dx testing platform. The QIAstat-Dx IVD panel will be able to detect all three APOE genotypes, APOE2, APOE3, and APOE4.

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The presence of APOE genes is associated with a higher risk of developing Alzheimer’s. Studies into APOE genotyping and Alzheimer’s risk suggest that different APOE variants may be associated with differentiated Alzheimer’s risk across age, sex, race, and ethnicity. Individuals with the APOE4 genotype have a higher risk of developing early-onset Alzheimer’s, with those having two copies of the APOE4 gene being more likely to develop clinical symptoms of the disease.

Multiple companies are developing diagnostic blood tests for diagnosing Alzheimer’s. According to GlobalData analysis, there are currently 76 active Alzheimer’s IVD platforms in development, with ten devices currently undergoing clinical trials. The commonly used diagnostic biomarker in IVD assays is the presence of tau proteins in the blood.

Lilly previously partnered with Roche to develop a tau biomarker assay. In April 2024, the companies secured a breakthrough device designation from the US Food and Drug Administration (FDA) for its Elecsys pTau217 plasma biomarker assay. The test is expected to be used as a screening tool for Alzheimer’s to help identify the presence or absence of amyloid pathology in individuals. A positive result signifies a high likelihood of having a positive amyloid positron emission tomography (PET) / cerebrospinal fluid (CSF) result.

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In November 2023, C2N Diagnostics published a study showing that its blood biomarker Precivity test helped increase the accuracy of amyloid positron emission tomography (PET) classification in pre-clinical Alzheimer’s disease. The study found that for evaluated biomarker, plasma p-tau217/np-tau217 had the highest accuracy followed Aβ42/Aβ40 and p-tau181/np-tau181 for identifying amyloid PET status. Each of the biomarker ratios for the p-tau217, Aβ42, and p-tau181 were more robust in identifying amyloid PET status, compared to their absolute concentration values.

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