By Kathleen Berger, Executive Producer for Science and Technology
St. Louis- based C2N Diagnostics raised an additional $15 million to enhance the company’s blood test designed to help doctors identify Alzheimer’s. The company initially developed PrecivityAD®, an innovative new blood test intended for use in patients with cognitive impairment. The diagnostic tool is designed for the accurate identification of Alzheimer’s disease from a patient’s blood sample.
“We combine a variety of biomarkers with a patient’s age into a test result that we call the amyloid probability score, or the APS. Amyloid is one of the proteins that’s implicated in Alzheimer’s disease,” explained Joel Braunstein, Co-Founder and CEO of C2N Diagnostics. “We’ve been able to validate that APS measure against known markers of Alzheimer’s disease, like amyloid pet scans or cerebrospinal fluid markers. And we know that the blood test result can provide a very accurate indicator of the presence of amyloid pathology in the brain.”
The PrecivityAD blood test for Alzheimer’s disease rolled out in 2020.
“We’re really the first group to be able to demonstrate through our collaboration with Washington University, who were the original inventors on some of the underlying technology, that one could actually use these blood markers to accurately identify the presence of amyloid pathology in the brain,” said Braunstein.
Braunstein said the test is important because it would be easily accessible and affordable.Braunstein explained Alzheimer’s is widely misdiagnosed.
“Alzheimer’s disease is a very difficult condition to diagnose,” said Braunstein. “An incorrect diagnosis can occur in up to 30% to 50% of patients, particularly in the early stages of disease. “
The blood test may allow for early identification of Alzheimer’s, giving patients access to clinical trials, newly approved FDA drugs and prevention strategies.
“New preventive therapies that are being studied in clinical trials,” he said.
While the company is working toward FDA approval, the blood test has authorization for use by interested clinicians across the U.S. and internationally. Blood samples are sent to C2N’s lab inside the BioSTL Building at 4340 Duncan Ave. in the Cortex innovation district.
“We can process hundreds of thousands of samples, but the global need for testing goes well beyond what we’re capable of doing just in St. Louis.”
C2N is developing partnerships with laboratories across the globe. The diagnostic tool would become broadly administered with FDA approval. Until then, clinicians can go to the company’s online portal and request the test’s blood sample collection kit.
Recently, the innovative biotechnology raised $15 million to advance the technology from the GHR Foundation, which focuses on Alzheimer’s prevention, and builds upon a $20 million investment from GRH in 2020. C2N plans to use the money for the development of PrecivityAD2.
“Using some of those resources to bring our next generation blood tests to the market, which is known as PrecivityAD2. That’s a test that’s going to not only be able to measure amyloid markers but also markers that are implicated in Tau tangle pathology, which is another protein component of Alzheimer’s disease,” said Braunstein. “The PrecivityAD2 test is our next-generation test that represents a continued advancement in innovation to improve diagnostic accuracy and be able to think about early and accurate diagnosis for patients.”