C2N Diagnostics’s detection test for Alzheimer’s disease is showing off some strong data coming out of the 12th Annual Clinical Trials in Alzheimer’s Disease conference. The St. Louis-based company said results from a study show the Aptus-Aβ test strongly predicts the presence of brain amyloidosis in a diverse population.
C2N Diagnostics said its blood-based in vitro diagnostic is being developed to predict amyloid PET scan results. It combines into a ratio, the concentration of amyloid beta (Aβ) isoforms Aβ42 and Aβ40 in human plasma, as measured by mass spectrometry. Amyloid PET scans accurately detect amyloid plaques – one of the hallmarks of Alzheimer’s disease – and are used in the workup and management of people with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.
In the study, C2N applied the Aptus-Aβ blood test to 415 samples previously collected from individuals enrolled at six different locations across the United States.
“We partnered with a number of [Alzheimer’s disease Research Centers] and we wound up getting access to biobank samples,” Joel Braunstein, MD, CEO of C2N, told MD+DI. “These are samples that individuals have consented to provide their blood.”
Despite differences in how each of the sites previously collected and stored the blood samples, as well as how each site defined presence of amyloid in the brain, the results showed that the Aptus-Aβ blood test yielded an area under the receiver operator curve (ROC-AUC) performance of 0.86. When the Aptus-Aβ results were combined with age and the presence of the ApoE4 gene, a known genetic risk factor for developing Alzheimer’s disease, the overall test performance increased to an AUC of 0.90.
“From an FDA perspective [the Aptus-Aβ] test does require a regulatory filing,” Braunstein said. “Aptus-Aβ does require clinical data. It’s a complex laboratory-developed test. The plan is for the test to be performed in our laboratory under CLIA.”
He added, “in terms of the pathway, we do see the in vitro diagnostic application as the ultimate trajectory for where we want to bring this test. But we also see an opportunity to be able to offer amyloid measurements – i.e. some of the values that we can currently measure in the Aptus platform, where we would report those results under CLIA.”