ST. LOUIS–(BUSINESS WIRE)–A peer-reviewed research article published today in the Journal of Experimental Medicine, titled “Blood plasma phosphorylated-tau isoforms track CNS [central nervous system] change in Alzheimer’s disease,” finds that the brain protein tau phosphorylated at position 217 (p-tau217) is measurable in blood by mass spectrometry and that this form of tau is a powerful early indicator of Alzheimer’s disease. Collaborators from the Department of Neurology at Washington University School of Medicine in St. Louis, including Dr. Nico Barthélemy and C2N scientific co-founder Dr. Randall Bateman, developed the novel mass spectrometry methods to quantify both total tau and multiple phosphorylated tau isoforms. C2N Diagnostics has acquired the exclusive worldwide commercial rights to the intellectual property associated with these blood biomarkers and will develop them for clinical diagnostic applications.
“C2N has extensive experience commercializing mass spectrometry assays, and we plan to optimize this assay to make it available for broad use,” says Dr. Joel B. Braunstein, CEO of C2N. “The ability to measure novel markers like p-tau217 in blood could markedly enhance the ability to identify and follow the disease at its earliest stages. Earlier detection likely means earlier intervention, which includes making it easier for patients to participate in clinical trials for prevention and treatment.” As a result of today’s news, Dr. Braunstein says C2N is one step closer to offering a comprehensive Brain Health Panel™ that will measure multiple features of Alzheimer’s disease and related disorders. A new p-tau test will complement the company’s already existing Aβ test, which is scheduled to reach physicians’ offices in the months ahead.
As reported by the Washington University research group, both p-tau217 and p-tau181 levels were specific for identifying Alzheimer’s pathology in patients at both the asymptomatic and symptomatic stages of disease. However, mass spectrometry is uniquely useful for detecting the very low quantity of p-tau217 circulating in blood, which performed superior to p-tau181 as an AD biomarker. Dr. Bateman shared the findings of the study involving 126 patients at this morning’s live session of the virtual Alzheimer’s Association International Conference, 2020.
C2N’s blood test of Aβ when combined with a p-tau assay has great potential to serve as a replacement to diagnosis using the current gold standards of cerebrospinal fluid (CSF) measurements or brain positron emission tomography (PET) imaging, both of which are invasive, inconvenient, and costly. Blood testing using mass spectrometry has the potential to allow for rapid, accurate, economical, and widely accessible testing.
C2N Diagnostics’ vision is to bring Clarity Through Innovation™. It focuses its therapeutic discovery efforts around mechanism-based approaches to prevent or stop the progression of human neurological disorders.
C2N’s diagnostic efforts revolve around bringing accurate, widely accessible, and cost-effective blood tests to the clinic for the betterment of patient care and brain health monitoring. Its lead commercial product is a mass spectrometry-based test that measures in blood multiple analytes including: Aβ42, Aβ40, and apolipoprotein E isoforms. This test is under development as an in- vitro diagnostic to predict brain amyloidosis as determined by PET scan results. For more information visit www.C2NDiagnostics.com.