C2N's Brain Amyloidosis Blood Test Receives Breakthrough Device Designation


If the C2N brain amyloidosis test becomes FDA approved, this could be the first blood-based screening test to predict brain amyloid PET scan results in those with memory complaints or dementia.

Dr Joel Braunstein

Joel Braunstein, MD, CEO of C2N Diagnostics

Joel Braunstein, MD

C2N Diagnostics announced that the FDA granted breakthrough device designation for C2N’s brain amyloidosis blood test that will screen for brain amyloid pathology in individuals being assessed for an Alzheimer diagnosis.

The company is currently enrolling participants in its pivotal Plasma Test for Amyloid Risk Screening (PARIS) study, a 2-phase clinical trial evaluating and validating the clinical diagnostic performance of the amyloidosis blood test in individuals at high risk for Alzheimer. If the test becomes FDA approved, it could be the first blood-based screening test to predict brain amyloid PET scan results in those with memory complaints or dementia, providing clinicians with a tool to determine the need for further diagnostic testing.

“The FDA granted us a breakthrough device designation, and we're enthusiastic about that,” Joel Braunstein, MD, chief executive officer, C2N Diagnosis, told NeurologyLive. “This identifies the test as addressing an important unmet medical need, an important public health problem, and it allows for more timely and potentially speedier access to the market. There's still the statutory requirement to demonstrate safety and efficacy even with the breakthrough designation; however, when you have that designation, it demonstrates that the FDA considers your program a priority and important with the potential to provide a significant impact on clinical care. At the same time, it affords us at C2N better communication and more interactions with the FDA. Thus, as we're making progress with our development program, we can have more correspondence with the FDA to improve our chances of staying on track and optimizing our chances of introducing a safe and effective diagnostic test for the clinic.”

The blood-based in vitro diagnostic uses plasma obtained through a traditional blood sampling technique. The collected sample is then sent to C2N Diagnostics, however, any clinical laboratory with proper instrumentation and training can perform the test. Once the blood sample arrives to the lab, the sample is processed, and the plasma component is then run through a mass spectrometer to obtain a readout of 2 peptide markers: amyloid beta (Aβ) isoforms Aβ42 and Aβ40.

Researchers calculate a ratio of Aβ42 over Aβ40 which will produce a value that is categorized into a normal/abnormal or positive/negative test result. The results of the Alzheimer pathology screening test would aid in the clinician’s’ evaluation of the patient. If clinicians receive a negative test, that would ideally present with a low concern for Alzheimer disease pathology in someone who is at risk, while a positive result would suggest further diagnostic testing is warranted out of concern for Alzheimer pathology.

Braunstein explained that this test has the potential to serve as an important tool for clinicians to utilize when a patient falls into a certain risk category for Alzheimer disease and is presenting to a specialist with subjective memory complaints.

“We want the physician to have a widely accessible tool that is cost effective and will enable timely and efficient screening for amyloid pathology in the brain as detected by PET,” Braunstein concluded. “Based on the test information, we hope that the clinician will be better equipped to recommend the patient for further analysis for Alzheimer disease pathology; or, decide that it makes more clinical sense to evaluate the patient for other conditions besides Alzheimer that might explain the cognition problem. Existing diagnostic tests for Alzheimer disease have various limitations. Some of these tests are expensive and logistically complicated to administer. Amyloid PET imaging, for instance, is costly, difficult to access for certain people in parts of the country, and exposes individuals who do not have Alzheimer disease to unnecessary radiation. The ability to provide a screening test with a blood draw has potential to improve the speed and efficiency of the overall diagnostic process.”


C2N Diagnostics Receives Breakthrough Device Designation from U.S. FDA for Blood Test to Screen for Alzheimer’s Disease Risk [news release]. St. Louis, MO: C2N Diagnostics; Jan. 29, 2019. https://www.c2ndiagnostics.com/press/press/2019/1/24/c2n-diagnostics-receives-breakthrough-device-designation-from-us-fda-for-blood-test-to-screen-for-alzheimers-disease-risk. Accessed Jan. 29, 2019.

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