Taiwan FDA Approves MagQu Plasma Aβ and Tau Tests for Alzheimer’s Disease

Alzforum – Taiwan FDA Approves MagQu Plasma Aβ and Tau Tests

Breakthrough: Non-Invasive Blood Test Approved for Supportive Alzheimer’s Diagnosis

The field of Alzheimer's disease (AD) diagnostics has reached a significant milestone. MagQu Co., a biotech company based in New Taipei City, Taiwan, announced that the Taiwan Food and Drug Administration (TFDA) has approved three of its immunoassays this January.

These products are designed to measure Aβ, Aβ42, and Total Tau in plasma, offering doctors and medical technologists a new, non-invasive tool to aid in the diagnosis of Alzheimer's disease (AD) and amnestic mild cognitive impairment (aMCI), as well as to evaluate the risk for dementia.

While the TFDA categorizes the test as supportive, meaning a formal diagnosis will still require PET scans or clinical tests, MagQu President Shieh-Yueh Yang, Ph.D., notes that this approval is a crucial step toward simplifying the AD diagnostic pathway.

MagQu’s Technological Edge: Unique Immunomagnetic Reduction (IMR)

The MagQu plasma Aβ and Tau assays stand out due to their proprietary technology, the Immunomagnetic Reduction (IMR) method. Unlike most other assays, which use two antibodies or mass spectrometry, the IMR assay utilizes a single antibody conjugated to magnetic nanobeads to capture and quantify each protein.

The core of the technology is measuring the deceleration of the particles' rotation in a magnetic field once they bind their target. This change is detected by a powerful magnetic sensor called a superconducting quantum interference device (SQUID).

This unique mechanism may explain a puzzling observation MagQu presented at the 2018 Alzheimer’s Association International Conference (AAIC): their Aβ42 signal actually increases with AD, which contrasts sharply with the drop in Aβ42 signal observed in most other plasma assays.

Professor Colin Masters of the University of Melbourne, who serves on MagQu’s Scientific Advisory Committee, views this as an "exciting time" for plasma Aβ and Tau assays, highlighting that "MagQu technology is very interesting and differs considerably from all the others."

High Match Rate: 90% Accuracy for Earlier Intervention

MagQu reports that by using cut-off values of combined plasma biomarkers, including the ratios of Aβ42 x Tau and Aβ42 /Aβ40, they could differentiate individuals with aMCI and AD from healthy controls approximately 90 percent of the time.

"Once the levels of combined plasma biomarkers are higher than the cutoff values, the subject would be strongly advised to get further tests, such as amyloid PET, MRI, and neuropsychological tests," Dr. Yang wrote. This high-accuracy, early-stage risk assessment is vital for facilitating timely intervention and potentially improving treatment outcomes.

A Competitive and Growing AD Blood Test Market

MagQu is not alone in the race for a high-performance blood test. Other major players, including Shimadzu Corp. (with whom Masters has worked on a mass spectrometry-based test), Quanterix, Roche Diagnostics, and Fujirebio, also have assays in development. C2N Diagnostics recently gained CLIA approval for its mass-spec Precivity Aβ test.

"The market for a high-performance AD blood test is so large that I think many players will emerge,” Masters predicts.

MagQu is also exploring applications for its IMR technology beyond AD. Last November, they reported a similar assay for plasma TDP-43, a promising biomarker for other neurodegenerative diseases, including frontotemporal dementia (FTD) and amyotrophic lateral sclerosis (ALS).

These advancements signal that AD diagnosis is poised to become more accessible, more scalable, and less costly, potentially transforming disease management for millions at risk globally.

Original coverage: Alzforum – Taiwan FDA Approves MagQu Plasma Aβ and Tau Tests

[Update Note on Accuracy] Please note that the stated ‘90% Accuracy’ for differentiating individuals with aMCI and AD from healthy controls is based on recent, optimized research. This figure represents an improvement in diagnostic performance compared to earlier published data.