C2N Diagnostics Receives Breakthrough Device Designation from U.S. FDA for Blood Test to Screen for Alzheimer’s Disease Risk

January 29, 2019 |

4 min read

FDA has granted Breakthrough Device Designation to C2N’s proprietary blood test for the initial screening of amyloid pathology in the brain associated with Alzheimer’s Disease C2N is conducting the PARIS Study, a two-phase pivotal clinical trial evaluating the clinical diagnostic performance of its test in individuals at high risk for Alzheimer’s Disease

ST. LOUIS--(BUSINESS WIRE)-- C2N Diagnostics today announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Device Designation for C₂N’s proprietary brain amyloidosis blood test. This test will be used to screen for brain amyloid pathology in individuals being assessed for an Alzheimer’s Disease diagnosis. To qualify for the FDA’s Breakthrough Device Program, a medical device must provide more effective diagnosis or treatment of a life-threatening or irreversibly debilitating condition, among other criteria. This program is designed to expedite the development and review of such medical devices.

C₂N also reported the launch of its pivotal PARIS Study (Plasma Test for Amyloid Risk Screening), a clinical trial that is evaluating and validating the clinical diagnostic performance of the C₂N brain amyloidosis blood test. If approved by the FDA, the C₂N test could become the first blood-based screening test to predict brain amyloid PET scan results in adults with memory complaints or dementia. The test will provide initial screening information to help doctors determine the need for further diagnostic testing.

Currently, tests that detect Alzheimer’s Disease pathology in the brains of living people have significant limitations. Amyloid PET imaging is costly, a difficult procedure to access, and exposes individuals who do not have Alzheimer’s Disease to unnecessary radiation. Cerebrospinal fluid biomarkers require a spinal tap, a needle insertion into the lower part of the back. Dr. Joel Braunstein, CEO of C₂N Diagnostics, stated, “A vital medical need exists for a simple, radiation-free, non-invasive, less costly diagnostic test for the initial broad screening of individuals with subjective memory concerns. The best chance we have for treating Alzheimer’s Disease will come from earlier detection and, thus, earlier intervention. A simple, safe blood-based screening test would be the first step in a multistage Alzheimer’s Disease diagnostic process. It would improve the speed and efficiency of the overall diagnostic process, and also afford significant cost savings to healthcare systems. At C₂N, we are making strong progress toward these goals and are committed to introducing a test that is widely accessible.”

The C₂N test could also accelerate the development of new drugs for Alzheimer’s Disease. “Recruitment of individuals into Alzheimer’s Disease clinical trials is a time-consuming and expensive process, because as many as 80% of candidates fail to meet inclusion criteria,” said Dr. Ilana Fogelman, VP of Clinical and Regulatory Affairs. “A screening test that pre-selects trial candidates more likely to have brain amyloidosis could decrease the screen failure rate and the overall time and cost of developing effective drugs for Alzheimer’s Disease.”

About the C₂N Test

The C₂N test is a blood-based in vitro diagnostic 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. Studies have demonstrated that a lower plasma Aβ42/Aβ40 ratio correlates with brain amyloidosis determined by amyloid PET scans. Amyloid PET scans accurately detect amyloid plaques – one of the hallmarks of Alzheimer’s Disease – and are used in the work up and management of people with cognitive impairment who are being evaluated for Alzheimer’s Disease and other causes of cognitive decline.

C₂N Diagnostics is the recipient of funding from the BrightFocus Foundation (Grant # CA2016636) and NIH’s SBIR program for support of the PARIS Study (Grant # R44 AG059489, entitled: “Plasma Aβ Isoform Concentrations in Cognitively Impaired Patients at Risk for Amyloidosis”).

About Alzheimer’s Disease

Alzheimer’s Disease is a progressive, neurodegenerative disorder that leads to cognitive decline and dementia. It affects approximately 5.7 million people in the United States and 34 million people worldwide, with many millions more at risk. The patient population for Alzheimer’s Disease is expected to nearly triple by 2050. It is the sixth leading cause of death in the U.S. and there are currently no treatments to prevent or delay disease progression.

About C₂N Diagnostics

C₂N Diagnostics (www.c2ndiagnostics.com) was formed by scientific co-founders Drs. David Holtzman and Randall Bateman of Washington University School of Medicine in St. Louis, MO and LifeTech Research, a technology research and venture development firm (www.lifetechresearch.com). C₂N is commercializing a suite of biomarker tests to enable early detection of debilitating neurodegenerative disorders before symptom onset, facilitate drug discovery, and enhance clinical drug development at lower risk and cost.

Besides its biomarker platform, C₂N is also developing therapeutics for neurodegenerative disorders. In March 2015, C₂N formed a global partnership with AbbVie to develop and commercialize a portfolio of anti-tau antibodies for the treatment of Alzheimer’s Disease and other neurological disorders. AbbVie is currently conducting phase 2 trials with the lead candidate ABBV-8E12 in Alzheimer’s disease and Progressive Supranuclear Palsy.