What if you could diagnose major mental health issues in 24 hours just by examining a patient's retina?

After 10 years of research and development—including $32 million in fundraising—a conclusive clinical trial, and an industrial scale-up, the leaders of Quebec-based diaMentis finally see the light at end of the tunnel. The company created this diagnostic aid that captures retinal signals using an electroretinogram (ERG) to then detect the biosignatures specific to schizophrenia, bipolarity and major depression. Last fall the tool was admitted to the Breakthrough Designation program of the Food and Drug Administration (FDA). This was a very important first step for Normand Tremblay, the co-founder and CEO of diaMentis. He hopes for approval “within 24 to 28 months” thanks to the support offered by the American health agency. Read: From legally blind to 20/20: How this made-in-Canada innovation has restored sight for thousands of patients Intended for “disruptive innovations,” this FDA program aims to speed up its certification process so that American patients can benefit from programs as quickly as possible. diaMentis thus benefits from valuable advice and regular feedback with the agency, which should help it get through the final approval stage without any problems. While the diagnostic tool has already been successfully tested on 1,000 Caucasian people, the company must prove its effectiveness on the African and Latin-American populations, who have a darker retina. The pigmentation of the skin also influences the retina. “The response to light flashes of the ERG is different according to ethnic origin, but we control these variations very well,” says the company's executive medical director, Dr. Marc Guérin. “We know it works and we are in the process of demonstrating it by collecting more data.” In fact, a clinical validation study is underway at 15 sites in the U.S. and Canada, including Harvard University, the Feinstein Institute, and the universities of Montreal, McGill and Toronto. If the tool meets the requirements of the FDA, Dr. Guérin says a "revolution that is coming" by the end of 2024 for the millions of patients who suffer from one of these three mental health illnesses. Read: Nearly 14,000 more mammograms are under review across Newfoundland and Labrador Schizophrenia, bipolar disorder and major depression are tricky and time-consuming to diagnose. Dr. Guérin, who has met with some 25,000 patients over his 50 years in practice, says these conditions evolve slowly and initially their symptoms are common to many pathologies. “You have to grope your way, try several medications,” he says. During this time, the person is often suffering and when the disease explodes, the damage is already done. “We can no longer go back, just minimize the consequences.” Much faster and more reliable diagnosis The technology developed by diaMentis is a game-changer. While people can wait years for a clear and accurate diagnosis about their mental health, they could see a diagnosis in less than 24 hours. “The retina being connected to the central nervous system, the analysis of retinal signals allows us to highlight the presence of several biosignatures, including those specific to schizophrenia, bipolarity and major depression. It makes the diagnosis more reliable, faster,” explains Dr. Guérin. “It’s like handing an EKG to a cardiologist. We will be able to act in prevention, before the signs of the disease are obvious.” In concrete terms, GPs and psychiatrists will be able to prescribe an ERG to their patients which will be carried out in dedicated centers (hospitals and designated clinics) and will require approximately 45 minutes. The data captured will then be transmitted to the diaMentis analysis center, which promises a result transmitted within 12 hours to the requesting doctor. “Our patented SaMD (Software as a Medical Device) platform is ready to meet North American demand,” says CEO Normand Tremblay. He specifies that once the approval of the regulatory authorities has been obtained, "our tool should gradually become available across the country according to agreements to be negotiated with the paying agents, such as the ministries of health of each province or territory, and the insurers private.” In a second step, the CEO intends to offer his diagnostic tool in Europe. “We are looking for partners and capital to deploy internationally in good conditions.” In the meantime, the diaMentis teams are already considering other possible applications for the interpretation of ERG signals, such as for the diagnosis of Parkinson's disease, Alzheimer's disease, autism or substance-induced psychotic disorders. “It will change the whole approach to mental health,” says Dr. Guérin who is hopeful of the tool being able to “tranform the lives of millions of people.” Possible delays ahead? Earlier this year, diaMentis board of directors decided "to proceed with a temporary collective layoff, including the entire management, for an indefinite period (in order) to finalize the refinancing phase initiated last December,” noted a press release. A total of 29 employees were laid off, including engineers, psychiatrists, neuroscientists, biostatisticians and mathematicians. This refinancing phase, which is still in progress, is necessary for the continuation of work in connection with the FDA so that the diaMentis technology is approved by the American agency by the end of 2024, said the company. In the meantime, the representative clinical validation study of the American mosaic continues, and interim results should be delivered to the FDA in about eight months. “Scientific development and relations with the FDA are up to date on everything,” the press release noted. This article has been translated from its original French and originally appeared on our sister site Profession Santé.

What if you could diagnose major mental health issues in 24 hours just by examining a patient's retina?

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