C2N is offering a simple blood test for Alzheimer’s disease to seek out amyloid plaque deposits
CEO: Joel Braunstein, M.D., MBA
Based: St. Louis, Missouri
The scoop: C2N Diagnostics is looking to make the diagnosis of Alzheimer’s disease easier with its non-invasive blood test.
What makes C2N fierce: Alzheimer’s is one of the cruelest human diseases: It robs people of their memories and can make grandparents forget their grandchildren or even their children. Some cases can dramatically change a person’s behavior and personality, depriving their families of the person they knew.
What makes this even more cruel is that there are so few medicines for the disease. For nearly 20 years there has been a dearth of innovation in a disease that, according to the CDC, killed 121,404 Americans in 2017, making it the sixth most common cause of death that year.
One of the theories being tested in trials to treat the disease is the amyloid hypothesis, which proposes that an accumulation of the peptide amyloid-β is the main cause of the condition.
The idea is that when amyloid-β clumps together to form deposits in the brain, it triggers neurodegenerative processes that lead to the loss of memory and cognitive ability that is observed in Alzheimer’s disease.
Biogen’s aducanumab therapy, currently under FDA review, attempts to clear these deposits as a path to treatment. C2N, meanwhile, also sees amyloid levels as a viable biomarker to assess whether someone has the disease.
For the longest time, there has been no simple and reliable test for diagnosing Alzheimer's. Currently, the diagnosis comes from a specialist testing a patient's memory or mental ability, or from brain scans, and these tests are usually completed late in the disease’s course. Although the disorder is not reversible, early treatment may help preserve daily functioning.
Early diagnosis would also enable testing of new drugs and other treatments. But the current approaches, such as PET imaging, can be expensive and rely on radioactive agents, while methods such as spinal fluid tests are invasive, complex and time-consuming and are usually reserved for research purposes.
Physicians want simpler, more cost-effective diagnostics, which C2N aims to provide. Last year it launched its blood test, PrecivityAD, in the U.S., and recently received a CE mark in the European Union.
It’s ordered by a doctor whose patients are “experiencing memory and thinking issues.” Though the test cannot diagnose a case of Alzheimer’s on its own, C2N’s non-invasive test can help predict brain pathology in people who are having trouble with cognition and can be used as a tool in a wider clinical assessment.
The test uses mass spectrometry to measure the amounts of certain amyloid-β peptides floating in the bloodstream, as well as versions of the fat-binding protein apolipoprotein E, a common risk factor for Alzheimer’s.
Combining those biomarkers provides an overall probability score on the likelihood of amyloid plaques in the brain, with high scores being consistent with positive PET scans. The score can assist the physician in reaching a diagnosis when added to clinical evaluations of a person’s cognitive decline and other factors.
The test was launched based on data from 686 patients older than 60 with subjective cognitive impairment or dementia. The PrecivityAD test correctly identified brain amyloid plaque status (as determined by quantitative amyloid PET scans) in 86% of the patients.
C2N is also developing a wider brain health panel of tests that search for multiple blood-based biomarkers for Alzheimer’s disease—such as the protein p-tau217—to assist with disease staging, treatment monitoring and differential diagnoses.
Investors: Last fall, C2N’s project was awarded more than $2.2 million by the Alzheimer’s Drug Discovery Foundation.