How Quanterix’s Breakthrough Device Designation Can Help Change the Trajectory of Alzheimer’s Disease Research thumbnail image

How Quanterix’s Breakthrough Device Designation Can Help Change the Trajectory of Alzheimer’s Disease Research

Currently, there is no FDA-approved test to non-invasively diagnose Alzheimer’s disease. For some time, the only effective diagnostic was the examination of the brain during autopsy. There have been some advances in Alzheimer’s diagnostics today, however, diagnosis typically relies on expensive PET scans or by measuring biomarkers in spinal fluid obtained through invasive and complex spinal tap procedures.

Why do doctors have to request spinal taps?

Existing biomarkers for Alzheimer’s disease, such as amyloid beta, tau, neurofilament, and glial fibrillary acidic protein, are abundant in the brain and spinal fluid but their concentrations in blood are low. However, thanks to technological advances like the Single Molecule Array (Simoa) technology developed by Quanterix, we now have a valuable new tool in the fight against Alzheimer’s: the ability to measure biomarkers of Alzheimer’s disease in blood. One of the most promising of these markers is p-Tau 181.

p-Tau 181 is an isoform of the tau protein responsible for many of the symptoms of Alzheimer’s disease and is found at elevated levels in the blood of Alzheimer’s patients. p-Tau 181 provides evidence of underlying Alzheimer’s pathology in the brain, which can be helpful in differentiating between various types of dementia, such as frontotemporal and Lewy Body dementia. We are not the only ones who see the utility of measuring p-Tau 181 for Alzheimer’s in blood – Quanterix was granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) in recognition of the transformative nature of this biomarker measurement as an aid in diagnostic evaluation for Alzheimer’s disease.

What is FDA Breakthrough Device Designation?

Breakthrough Device Designation (BDD) is given by the FDA to medical devices that may offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases.

For a biotechnology company to obtain BDD, the device must meet at least one of the following criteria:

  • Represents breakthrough technology
  • No approved or cleared alternatives currently exist
  • Offers significant advantages over existing approved or cleared alternatives
  • The technology’s availability is in the best interest of patients

BDD is a rare and significant achievement. The FDA has granted only 300 designations during the program’s history, including 50 in 2020. Quanterix currently holds two BDDs – one for p-Tau 181 in the context of Alzheimer’s disease, and another for neurofilament light (Nf-L) in the context of multiple sclerosis.

What does this mean for biomarker research?

Simoa technology has the potential to provide easier and earlier diagnosis of Alzheimer’s disease in ways that are not possible with other technologies. The superior analytical sensitivity of Simoa, combined with Quanterix’s fully automated HD-X analyzer, allows anyone to access supercharged assay performance. Greater sensitivity can mean earlier, more economical, and less invasive testing; and with these advances comes the potential to develop novel therapeutics that could slow or stop the progression of incurable diseases.

For academic research, this means a potential new frontier of discovery. The sensitivity afforded by Simoa allows researchers on the forefront to evaluate these biomarkers early in the disease continuum, further expanding our knowledge of the disease, and potentially enabling avant-garde therapeutic development. Simoa can allow researchers to see markers they never could before in matrices that were undetectable in the past. The more we know about Alzheimer’s disease through the power of discovery research, the more we may be able to affect change in diagnosis, therapeutic intervention, and patient quality of life.

For clinical research, the ability to measure biomarkers in liquid biopsy samples is priceless. Clinical researchers can design cost-effective, accessible trials, gaining biomarker insights more readily and frequently, and opening their trials to patients across the globe. Furthermore, advances in clinical research are easy to translate to the clinic when the samples are simple to collect and measure – and few matrices are simpler or more accessible than blood. The PET scan and lumbar puncture were the way of the past – the diagnostic paradigm of the future is liquid biopsy and speedy results, which Simoa can enable.

How can Quanterix specifically help in Alzheimer’s research and discovery?

Alongside the markers granted BDD by FDA, Quanterix offers a full library of neurology biomarkers, all leveraging Simoa sensitivity. These markers (AB40, AB42, Nf-L, GFAP, p-Tau 181, p-Tau 231, total Tau, and more) have the potential to accelerate the discovery of neuro-diagnostic therapies to prevent and treat devastating conditions.

The most precious element of living with Alzheimer’s is time. Time with family, friends, and the people in life that mean the most. Quanterix focuses on bringing new discoveries in disease to the forefront with our Simoa precision instruments to give patients, physicians, and families meaningful time back in their lives.

Click here to learn more about the advancements Quanterix technology has made.