Dive Brief:

• FDA has awarded breakthrough device designation to a blood test aiming to screen for Alzheimer’s disease risk.

• C2N Diagnostics is developing the test to enable physicians to predict whether a patient has a buildup of amyloid, protein fibrils often found between brain neurons in Alzheimer's patients, before sending them for expensive PET imaging.

• C2N recently moved the test into a two-phase pivotal clinical trial it hopes will generate data to support FDA marketing authorization.

Dive Insight:

Physicians are currently limited in their action options when people present with memory concerns. To confirm the presence of amyloid plaques characteristic of Alzheimer’s, physicians typically must order amyloid PET imaging or a spinal tap. But these procedures have limitations relating to their invasiveness, cost and other factors.

Given the shift in drug pipelines toward very early stage Alzheimer’s, there is a need in clinical trials, and potentially in routine healthcare, for means to screen large numbers of people with minor memory problems.

Neither amyloid PET imaging or spinal taps are well suited to such broad screening and the screen failure rate in Alzheimer’s R&D is high, in part because of the lack of an effective initial filter.

Seeing that unmet need, C2N is developing a blood-based in vitro diagnostic to predict amyloid PET scan results. The test uses mass spectrometry to measure the concentration of two isoforms of amyloid beta in plasma samples. In doing so, C2N CEO Joel Braunstein thinks his company can change how Alzheimer’s is diagnosed.

"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," Braunstein said in a statement.

As a result of the breakthrough designation, C2N’s efforts to realize that vision will now benefit from extra FDA support and, if the test makes it that far, a fast-track review at the clearance stage.

An updated figure from FDA this week indicated 112 devices have been granted breakthrough status since the program's inception in April 2015. C2N has initiated a pivotal trial to evaluate the performance of the blood test ahead of an anticipated filing for approval.