Plasma markers for Alzheimer’s diagnosis

Agappe Diagnostics Ltd.

Agappe becomes the first Indian company to manufacture FDA-cleared plasma markers for Alzheimer’s diagnosis

India is home to over 5 million Alzheimer’s Disease (AD) patients–the third highest globally. With cases expected to double in the next decade due to an aging population, early detection is crucial to slow/stall disease progression and alleviate suffering.

Agappe will be the first Indian company to manufacture plasma-based biomarkers for AD, pioneering a breakthrough in early dementia diagnosis through fast, affordable, and accessible blood-based testing across the country.

Agappe has started the domestic manufacturing of plasma biomarkers–Amyloid Beta 1-42 and phosphorylated Tau (pTau) 217–marking a major leap in India’s AD diagnostics landscape. This is in collaboration with Fujirebio Inc, Japan, whose products got certified by US FDA in May 2025, through CDMO agreement & technology transfer.

These advanced plasma markers form the backbone of the latest blood-based testing technology for AD, offering a simpler, faster, and less invasive alternative to traditional PET scans or CSF analysis. These biomarkers are used to assess the ratio of pTau217 to Amyloid Beta 1-42 in the blood, a key indicator of AD pathology.

These reagents are specifically optimized for Agappe’s fully automated Mispa i60/Mispa i121 CLEIA platform, designed for high-throughput, precision testing in clinical laboratories.

The Mispa i60/Mispa i121, equipped with advanced immunology capabilities, will serve as the foundation for deploying these Alzheimer’s diagnostic tests across India to detect dementia early and cost-effectively.

With in-house manufacturing of these critical biomarkers, Agappe is aligning global innovation with India’s diagnostic needs to deliver accessible IVD solutions to India’s rural and urban masses.