The 2022 Alzheimer’s Association International Conference (AAIC) was held in San Diego from July 31 to August 4. The AAIC is an annual global forum to advance the science of dementia detection, diagnosis, and treatment. Quanterix has made an impact at the last few conferences, and the 2022 meeting was no exception.

Blood Biomarkers for Alzheimer’s Disease

The Quanterix Simoa® platform has opened up new frontiers for the detection of Alzheimer’s disease (AD) biomarkers from plasma samples. At AAIC 2022, Quanterix scientists and their international collaborators presented their latest breakthroughs in pushing the limits of detection for several key Alzheimer’s biomarkers. The data reveal how single-molecule detection can radically improve the ease, speed, and accuracy of diagnosis for several key stages of cognitive disorder. Let’s take a look at two of Quanterix’ presentations at AAIC 2022 to see what is now possible.

Phosphorylated Tau for Alzheimer’s Diagnosis — A Fully Automated Lab Developed Test (LDT)

Phosphorylated tau (p-tau) is a biomarker with the potential to recognize if patients with mild cognitive impairment are on the Alzheimer’s spectrum. Early and accurate detection of this protein in the blood would obviate the need to use cerebrospinal fluid (CSF) based assays, bringing a great deal of flexibility to diagnoses.

Quanterix, in association with Vrije University Amsterdam, presented a poster at AAIC 2022 that detailed the extensive validation of plasma p-tau181 as an LDT test with strong discriminatory power, on the Simoa HD-X Analyzer. They calculated a critical p-tau181 concentration cut-off level by comparing plasma samples from 74 patients confirmed to have Alzheimer’s disease with 76 age- and sex-matched patients who were cognitively normal. Using decision threshold and Youden’s analysis, the researchers determined the cut-off value of 16.7 pg/mL. ROC analysis showed an AUC of 0.845 for discrimination of AD from non-AD, indicating a strong degree of sensitivity and specificity for this biomarker.

The data shows the enormous power of the Simoa platform to discriminate AD from non-AD cases in both rule-in and rule-out diagnostic scenarios.

Clinical Aspects of Brain Biomarker Use

With the advent of several powerful blood-based biomarkers for brain disorders, clinicians have a new set of tools in their repertoire. For AD, these biomarkers include p-tau as discussed above, and others such as NfL (neurofilament light chain) and GFAP (glial fibrillary acidic protein). Biomarkers for multiple sclerosis, traumatic brain injury, and even general brain health are also being developed with high sensitivity.

Quanterix presented a talk outlining the range of applications of these biomarkers in a clinical setting. There are three main arenas in which digital detection of these biomarkers, as provided by the Simoa platform, are of tremendous utility. These are research and development (R&D), LDTs, and in vitro diagnostics. Brain biomarkers in these scenarios can contribute to understanding AD pathology, to approve drugs to prevent or slow down AD and to aid in patient diagnosis at clinical routine visits.

Time is of the essence for the diagnosis of brain disorders. Some patients with mild cognitive impairment will progress to dementia. In some cases, time delays in diagnosis can preclude efficacious treatment options. Blood-based analyses such as Quanterix’s p-tau181 LDT assay, when used in conjunction with other diagnostic methods, afford clinicians the ability to proceed from patient presentation to accurate diagnosis in record time. This has the potential to bring treatment to far more people.

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This test was developed, and its performance characteristics determined by Quanterix in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.