FDA Clears QyScore Imaging Software for CNS Diseases


The software, developed by Qynapse, provides analysis of brain MRI markers in diseases such as Alzheimer disease, Parkinson disease, and multiple sclerosis.

The FDA has cleared the use of QyScore software in the analysis of brain magnetic resonance imaging (MRI) markers in neurodegenerative diseases such as Alzheimer disease, Parkinson disease, and multiple sclerosis (MS), among others.1

The software, which includes an advanced user interface combined with patient reports, was developed by Qynapse, a medical technology company based in France. The software’s results, which the company noted are usually available in minutes, are presented in comparison to a database of healthy subjects to aid neurologists and radiologists in their assessments.

"QyScore makes a difference for the diagnosis of dementias at an early stage of the disease when it remains a challenge,” Bruno Dubois, MD, professor of neurology, Sorbonne University, and director, Memory and Alzheimer's Disease Institute, Pitié Salpêtrière Hospital. “The automatic quantification of markers such as brain atrophy, white matter hyperintensities and more, provides highly valuable help to support a timely diagnosis and an efficient monitoring of disease progression."

In Europe, QyScore has been commercialized since it received CE mark approval in September 2017.

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Qynapse’s software allows physicians to view quantified longitudinal changes in regions of interest in the brain, preventing the inter-rater and intra-rater variability in image reading. This, in turn, cuts down on both the time and cost of analysis.

In April 2019, the company released validation results of a 130-patient study, which suggested that there was an “excellent agreement” between manual and automated lesion breakdown in the entire MRI scan dataset. This, they argued, confirmed the value of the QyScore software. At the time, Clarisse Longo Dos Santos, vice president, clinical development, Qynapse, noted that the real-world analysis comparison by the 3 experts, on a wide variety of lesion loads, pathologies, and scan manufacturers, supports the accuracy and power of the software.2

"FDA clearance is a major milestone to expand the commercialization of the software within the U.S.," said Olivier Courrèges, CEO, Qynapse. "Qynapse will accelerate collaboration with experts and healthcare providers in the U.S. to pursue its journey for better patient care in neurology."



1. Qynapse receives FDA clearance for QyScore®, a novel imaging software for central nervous system diseases [press release]. Paris, France: Qynapse; Published February 3, 2020. prnewswire.com/news-releases/qynapse-receives-fda-clearance-for-qyscore-a-novel-imaging-software-for-central-nervous-system-diseases-300997612.html. Accessed February 3, 2020.
2. Qynapse releases new validation results of QyScore® performance. [press release]. Paris, France: Qynapse; Published April 11, 2019. qynapse.com/news/qynapse-releases-new-validation-results-of-qyscore-performance. Accessed February 3, 2020.

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