C2N Develops Blood Test to Measure Tau Forms in Alzheimer’s Research

Lindsey Shapiro, PhD avatar

by Lindsey Shapiro, PhD |

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C2N Diagnostics has developed a new assay that precisely measures blood levels of four forms of tau, a protein involved in the brain changes observed in Alzheimer’s disease.

Called the plasma tau multianalyte assay (p-tau MAA), the test is intended to be used for research purposes only and does not have current approval for use in clinical practice.

According to C2N, p-tau MAA has a variety of uses and will aid scientists in better understanding disease biology, screening individuals for clinical trials, and monitoring responses to investigational treatments.

Eventually, C2N hopes the test will reach the clinic to help healthcare professionals make earlier diagnoses.

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“This development builds on our team’s history of providing exceptional laboratory services and products in the field of brain health,” Joel Braunstein, MD, C2N co-founder and CEO, said in a press release.

“Our team has worked tirelessly to achieve this p-tau advancement that adds to our existing efforts to bring accurate, widely accessible and cost-effective blood tests to the clinic for the betterment of patient care. We look forward to sharing important data about the performance of our p-tau MAA test at upcoming medical meetings and in peer-reviewed publications,” Braunstein added.

Various forms of tau accumulate and clump together in the brains of those with Alzheimer’s disease, where they are thought to play an important role in disease progression. Often, these tau forms have undergone an excessive amount of a modification called phosphorylation, which allows tau to more easily aggregate and makes it harder to break down.

These aggregates are thought to precede the loss of nerve cells and cognitive impairments in Alzheimer’s and are thus considered to have potential as early disease biomarkers.

The p-tau MAA assay will measure levels of two tau forms — tau217 and tau181 — in both phosphorylated and nonphosphorylated states. These two tau forms in particular have been proposed as early predictors of cognitive decline in Alzheimer’s patients.

In doing so, C2N believes that the range of biomarkers that can be used to help diagnose Alzheimer’s and monitor brain health will be broadened.

C2N previously developed a clinically available test, PrecivityAD, to measure other proteins that play critical roles in Alzheimer’s development. The blood test measures the ratio of two forms of the amyloid beta protein — amyloid beta 40 and 42 — which play a strong role in disease progression.

It also determines which type of the apolipoprotein E (ApoE) is present in the blood sample. Mutations in the gene encoding ApoE, and the subsequent development of abnormal forms of the protein, are associated with Alzheimer’s risk.

By measuring both ApoE and amyloid proteins, PrecivityAD is thought to predict the likelihood of developing amyloid plaques in the brain, a hallmark Alzheimer’s feature, in people with signs of cognitive decline.

C2N says that using the p-tau MAA assay in conjunction with PrecivityAD may amplify the ability to detect Alzheimer’s pathology at early disease stages before the onset of cognitive symptoms.

“We are encouraged by the results from C2N’s existing PrecivityAD blood test measurements and excited by the addition of the p-tau MAA,” said Howard Fillit, MD, co-founder and chief scientific officer at the Alzheimer’s Drug Discovery Foundation.

“In the future, we expect that a combination of tests, including C2N’s, that each measure different aspects of Alzheimer’s biology will allow more healthcare providers to offer early Alzheimer’s diagnosis to patients with the aid of validated blood test results. This will also decrease the need for more invasive and expensive tests,” Fillit added.

The GHR Foundation is one of C2N’s funding partners for the development of its Alzheimer’s blood tests.

“This remarkable development by C2N brings the field one step closer to the goal of preventing Alzheimer’s disease by screening healthy adults and providing treatments prior to cognitive symptoms,” said Fred Miller, Alzheimer’s Initiative lead and chief operating officer at GHR Foundation.

“GHR is committed to our deep partnership with C2N as we together reimagine what’s possible in the prevention and treatment of Alzheimer’s disease,” he added.