Mental health and precision medicine - Owner of a breakthrough diagnosis supporting technology recognized as a major scientific advancement in the United States, the Quebec company diaMentis is beginning its final phase of development with the FDA (F
QUÉBEC, Sept. 22, 2022 /CNW Telbec/ - The only company known in the world to capture retinal signals and decipher the specific biosignatures of schizophrenia (SZ), bipolar disorder (BP) and major depressive disorder (MDD), diaMentis intends to offer its rapid diagnosis supporting technology to general practitioners and psychiatrists in the United States and Canada by the end of 2024.
Of all the medical disciplines, psychiatry is the only one with no objective tool to help diagnose and monitor patients undergoing treatment. Once authorized, this new technology could transform the lives of millions of people thanks to an electroretinography (ERG) test of approximately 45 minutes further analyzed by diaMentis' patented SaMD (Software as a Medical Device) platform. It should be noted that in the United States 1, more than 29 million adults suffer from one of these diseases, while in Canada, more than 2.3 million people aged 15 and over are affected 2.
The only known company worldwide to have a Breakthrough Designation (major scientific advances) from the American Agency related to biosignatures analysis and diagnosis support for SZ and BP. A final validation step now separates diaMentis from FDA authorization. This step consists of finalizing the conditions for obtaining ERG signals and the selection of the most efficient mathematical and biostatistical analysis models via a clinical validation study with a representative sample of the US population.
Among these diseases, two are irreversible, SZ and BP, while MDD can potentially be long-lasting and even present throughout the patient's life in some cases.
As several co-factors co-exist and overlap within these pathologies, diagnosis is often framed and obtained over very long periods of time. Thus, people with SZ or BP usually wait between 5 and 7 years before obtaining a clear and precise diagnosis and being adequately supported for their treatment and medical follow-up.
These long delays, where the disease continues progressing without being diagnosed, lead many people with SZ or BP to lose the ability to have a functional life whereas if they were diagnosed in the early stage of these diseases – that is, when the warning symptoms make their appearance - they could be quickly treated and able to maintain a functional life.
Health systems would also benefit from its use as the annual medical, social, and economic costs of SZ and BP reach $155 billion and $213 billion in the United States 3,4. These costs are also observed in Canada within proportion.
Since the retina is connected to the central nervous system, retinal signals analysis allows us to highlight the presence of several biosignatures. Thanks to this new medical technology, a conclusive diagnosis by the clinician - general practitioner or psychiatrist - could now be confirmed or invalidated in less than 12 hours following retinal signals examination rather than waiting an average of 5 to 7 years given the absence of diagnostic supporting tools, as is currently the case in mental health.
Appropriate treatment can be provided earlier in the course of the disease and the follow-up of each patient's treatment can be monitored by subsequent retinal signal examinations.
"Our progress and our dialogue with the FDA motivates us to enrich this portfolio of rapid diagnostic supporting solutions for the benefit of each patient, and their natural caregiver, struggling with mental illness on a daily basis. Being able to contribute in the near future to solving one of the most important problems in mental health, being the lack of rapid diagnosis at the early stage of the disease, will one day allow health systems around the world to benefit from a diagnostic supporting tool accessible to every physician involved with mental health issues. Our innovative technology could, with additional necessary capital and resources, also be used for other psychiatric and non-psychiatric indications." – Normand Tremblay, Co-Founder and CEO, diaMentis
Resulting from the work of Laval University, diaMentis holds a robust intellectual property on the analysis of retinal signals with patents recognized in 156 countries. The company has been awarded a Breakthrough Designation by the FDA, the world's largest regulatory agency. diaMentis has 118 individual and institutional shareholders in Quebec and Canada. It has raised $32M, primarily from the private sector, for the development of its rapid diagnosis supporting technology for SZ, BP and MDD, since its university spin-off in 2016. With growing scientific literature supporting its initiatives, diaMentis currently has 31 employees from eight different nationalities holding 19 doctorates or master's degrees and conducts its validation study at 15 American and Canadian clinical sites which include Harvard University, the Feinstein Institute, the University of Rochester, the University of Montreal, McGill University and the University of Toronto.
Source: National Alliance on Mental Illness, 2020 https://www.nami.org/mhstats
Source: Cloutier M, Aigbogun MS, Guerin A, Nitulescu R, Ramanakumar AV, Kamat SA, et al. The Economic Burden of Schizophrenia in the United States in 2013. The Journal of Clinical Psychiatry. 2016; 77(6): 764-771.
Source: Leona Bessonova, Kristine Ogden, Michael J Doane, Amy K O'Sullivan, Mauricio Tohen. The Economic Burden of Bipolar Disorder in the United States: A Systematic Literature Review, 2020. ClinicoEconomics and Outcomes Research, 2020; 12: 481-497.
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