FDA assigns breakthrough status to blood test for Alzheimer's risk

Diving Brief:

• The FDA has badigned the designation of a revolutionary device to a blood test to screen for the risk of Alzheimer's disease.

• C2NOT Diagnostics is developing the test to allow doctors to predict whether a patient is having an accumulation of amyloid protein fibrils, often found between brain neurons of patients with Alzheimer's disease, before sending them for expensive PET imaging .

• C2NOT recently transferred the test into a pivotal two-phase clinical trial which, hopefully, will generate data to support FDA's marketing authorization.

Insight on diving:

Doctors are currently limited in their options of action when people have memory problems. To confirm the presence of amyloid plaques characteristic of Alzheimer's disease, physicians usually need to request amyloid PET imaging or spinal puncture. But these procedures have limitations related to their invasiveness, cost and other factors.

Given the evolution of drug pipelines to Alzheimer's disease at a very early stage, clinical trials, and potentially routine health care, need ways to detect a large number of people with drug-related problems. minor memory.

Neither amyloid PET imaging nor spinal cuts are well suited for such wide screening and the failure rate of screening in Alzheimer's research is high, in part because of the lack of An effective initial filter.

Seeing this need not satisfied, C2NOT develops a blood base in vitro diagnosis to predict the results of amyloid PET. The test uses mbad spectrometry to measure the concentration of two isoforms of beta-amyloid in plasma samples. In doing so, C2NOT CEO Joel Braunstein believes his company can change the diagnosis of Alzheimer's disease.

"A simple and safe blood screening test would be the first step in a multi-step Alzheimer's disease diagnosis process, which would improve the speed and effectiveness of the entire blood test. diagnostic process and would also allow health systems to realize considerable savings, "Braunstein told a statement.

As a result of the revolutionary designation, C2NOTEfforts to achieve this vision will now benefit from additional support from the FDA and, if the test results at this stage, from expedited review at the validation stage.

An updated figure released by the FDA this week indicates that 112 devices have achieved the status of innovator since the launch of the program in April 2015. C2NOT has launched a pivotal trial to evaluate the performance of the blood test prior to the submission scheduled for approval.