By Benjamin Ross
September 16, 2019 | A Melbourne-based startup is looking to predict heart failure and other cardiac diseases using a patient's saliva.
The company, ESN Cleer, has developed a stick-like, hand-held device that collects saliva from a user and, using nano-sensors, measures biomarkers for the potential of disease development. The device comes in two parts: an electronic handle and a disposable sensor that can be easily detached.
The yet-to-be-named device was designed by ESN Cleer's CEO, Leopoldt de Bruin, with the assistance of RMIT University professor Sharath Sriram, who were both interested in in creating nanotechnology products to predict heart failure.
According to Sriram, brainstorming sessions in February 2018 resulted in rapid product development over the next 12-16 months. "While the original concept of the device was very complex and invasive, we worked together to create a concept that was quick-to-market and easy for users to engage with," he tells Diagnostics World News in an email interview.
RMIT University is the core technology partner for the project, Sriram says. The nanotechnology-enabled sensors that detect the biomarkers have been developed at RMIT. The data these sensors generate are analyzed by a data analytics platform developed by ESN Cleer.
"We are a team of nanotechnologists and electronic engineers who unlock new functionalities in materials and interface them to electronics to utilize these properties," Sriram says.
The device collects saliva from the user and will provide analysis and feedback to them via a smartphone app within seconds.
According to Sriram, the value of a device like this is that it provides a personalized baseline for the user, while also monitoring and tracking changes to biomarkers that indicate potential heart failure. He says the device does not depend on constant use to establish a baseline, either, requiring use only once a week or month depending on the user’s risk profile.
"One important thing to consider is that every person is different," says Sriram. Our individual "normal" biomarker levels as well as our variations are different. "Given only 16% of the population are genetically predisposed to heart failure, the others are due to lifestyle factors. Any risk factors and their influence can be monitored with this technology."
Heart failure and cardiac disease is a relevant starting point for the device's diagnostic capabilities. Cardiovascular disease accounts for nearly one-third of all global disease deaths each year, according to the company. In an official statement, ESN Cleer says they envision the device to be used to predict cancer risk down the pipeline.
Monitoring patients through saliva is a somewhat nuanced approach to diagnostics, though the method has been gaining traction in recent years.
"Most diseases and ailments change levels of biomarkers in the human body—this impacts levels in all human fluids that include blood, saliva, sweat, and tears," Sriram says. "Concentrations would vary in each, but the presence of certain biomarkers (especially combinations) are known medically to correlate [to] specific diseases."
ESN Cleer has recently signed a deal to bring the device to market. The company says it is researching and developing the device for pilot manufacture alongside RMIT University and the Innovative Manufacturing Cooperative Research Centre (IMCRC), with expectations it will hit market by 2021.
Sriram says they want to distribute the device globally as a direct-to-consumer diagnostic, with regulatory approvals with various international bodies being completed with initial market of Australia, followed closely by the US.
"We are expecting people to buy this out of interest but especially due to increasing awareness about managing one's health," he says.