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The company plans to bring the test to market in Canada within the next 18 months
In 2022, over four million Canadians, or 10% of the population, were estimated to be living with diabetes, which increases their risk of cardiovascular and renal complications. It also results in costs of approximately $30 billion for our healthcare system.
Currently, the diagnosis of diabetes is not really a problem, as simple glycated haemoglobin (HbA1c) over 7% is prediabetes, and over 7.5% diabetes both type 1 and 2, Dr. Pavel Hamet, Professor at the University of Montreal and Founding President of precision medicine compny OPTITHERA, explained to VatorNews.
Rather, the bigger issue is in regards to prevention.
"At the onset neither physician nor the patient have presently a clue to who will get complications and which one. We have currently several classes of new medications with demonstrated capacity to prevent complications. They tend to be expensive, and several may lead to various side effects," Hamet said.
"It is therefore a current recommendation to reserve these medications to diabetics (type 2) at demonstrated high risk. This is usually considered as someone who already had myocardial infarction or stroke or damaged kidney function. For us this is a significant barrier for prevention. We aim, by including personal genetic susceptibility to complications, to predict and prevent prior to any presence of complication."
OPTITHERA's products include the first-ever genomic test predicting the risk of diabetic complications. In order to get the test to market, the company announced earlier this week that it signed a new agreement with ELNA Medical Group, Canada's largest network of medical clinics, serving more than 1.6 million Canadians annually, along with Génome Québec, as part of Genome Canada's Genomic Applications Partnership Program (GAPP).
Founded in 2016 by Hamet and Johanne Tremblay, both professors at the University of Montreal, OPTITHERA has analyzed data from more than 20,000 type 2 diabetes patients from 20 countries. Based on these clinical studies, and with the help of artificial intelligence, researchers were able to develop a genome test that can inform a physician if a patient is at risk of developing complications related to type 2 diabetes.
Using a saliva sample collected at a clinic or at home, OPTITHERA will analyze the patient's genetic profile to determine the patient's risk of developing complications related to diabetes. The resulting polygenic risk score (PRS) is based on gender, age of onset, ethnicity, and data from the individual's genetic code.
To date, nearly 600 genomic variants associated with cardiovascular and renal disease in more than a million people have been selected for the project. A risk prediction model was developed by analyzing the clinical and genetic data of participants from 17 countries included in the company's ADVANCE trial, one of the largest clinical studies in the world for patients with diabetes.
Data from the ADVANCE trial demonstrated that combined intensive blood pressure and glucose control decreased cardiovascular death by 24%. The model also identified a high-risk group in whom it decreased the mortality rate by 47%.
"Diabetic complication are a perfect example of polygenic disease. Most people know of genetics as a disease caused by one gene, with little possibility to avoid it. All the complication are caused by many genetic determinants, most of them identified over the last two decades," Hamet explained.
"Polygenic risk score combines all well proven genomic variations in one’s DNA and combined them with a few clinical factors such as age of onset of T2D, its duration, sex and genetically defined ethnic origin."
The newly announced partnership also involves a $12.8 million investment that includes $2 million from Genome Canada, $2 million from Génome Québec, $1 million from OPTITHERA, and the rest from ELNA. The money will cover the real-life clinical study of more than 2,500 participants to demonstrate the clinical utility of it polygenic risk score (PRS) test.
The project will finance a quality management system necessary to obtain an ISO 13485 certification for commercialization of its PRS software and efficient knowledge transfer to healthcare professionals and patients; a prospective RWD of the clinical utility of the PRS in clinical practice settings; and a cost-effectiveness data of the PRS on CVD and global impact of PRS testing on both CVD and renal complications, to support test reimbursement.
The plan is to reach the market within 18 months in Canada and to apply for reimbursement by Canadian health providers and then enter the US market in the second year.
"Success for me would be that our test helps improve T2D patients management so that fewer patients have diabetes cardiovascular complication and have to be dialyzed. My motto is: predict to prevent," said Hamet.
"The purpose of our project is to translate the best of basic research into clinical utility for patients and sustainability of our healthcare systems."
(Image source: optithera.com)
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