Why this lab-on-a-patch device could propel us towards a preventative healthcare future.
Imagine if there was a device that had the capability of identifying early biomarkers of disease, transforming our healthcare system from reactive to proactive, and eventually preventative.
With chemical engineer Peter Vranes at the helm, Victorian-based start-up Nutromics is on the path to do just that, through the development of its lab-on-a-patch DNA-based sensor.
An entrepreneur at heart
Beginning his engineering career in the oil and gas sector, Vranes has been a serial entrepreneur for 20 years, producing ranges of skincare products sold in 1,500 outlets across Australia.
He went on to develop products to improve skin health in collaboration with a German manufacturer that measures carotenoids in the skin to determine antioxidant levels.
Having always been interested in continuous monitoring and biofeedback, Vranes subsequently developed the idea for Nutromics.
“I started asking what the company can monitor outside of carotenoids, such as micronutrients,” he says. “A lot of people are deficient in micronutrients, and you could tailor your diet accordingly if you only knew.”
What started as a side business soon grew into a full-time gig, with Vranes bringing on co-founder Hitesh Mehta.
Realising micronutrients might not be high on everyone’s priority list, they pivoted to monitoring glucose through a microneedle as an alternative to the 1-centimetre needle used in continuous glucose monitors.
But in 2020, the pair came across bioanalytical sensor technology by Professor Kevin Plaxco from the University of California Santa Barbara that was a game changer.
“Right now, pretty much the only molecular target you can continuously measure is glucose,” says Vranes. “But this [sensor] allows us to measure any diagnostic target, continuously and in real time.”
After licensing the technology, Nutromics grew from a company of two to 50, raised $20 million in funding, and is now in the process of clinical trials.
How it works
The Nutromics DNA-based sensor works via a similar mechanism to sensors in your body, says Vranes.
“We have a synthetic DNA-based sensor on the tip of a micro needle, which gives us access to the interstitial fluid (ISF) just under the skin.”
Ever wondered what that clear liquid in a blister is? That’s ISF, says Vranes, and apparently, we’re “bathed” in it.
[embedyt] https://www.youtube.com/watch?v=QcAt8borwb4[/embedyt]
When the one-millimetre microneedle pierces the skin, the attached DNA-based sensor is designed to recognise targets of interest in ISF.
“It changes shape, [emitting] a signal change we can measure,” he says. “We know the target is present and we can quantify how much of it is present.”
A new indication for continuous monitoring
The first place Mehta and Vranes wanted to apply their new technology was in intensive care units (ICU) where critically ill patients abound.
“If it works in the ICU, it works everywhere – because that’s the toughest environment,” says Vranes.
Working with hundreds of clinicians to identify the diagnostic target they’d most want to monitor, Nutromics zeroed in on the antibiotic vancomycin.
Used to treat life-threatening bacterial infections such as sepsis, clinicians dose vancomycin every day. However, it’s difficult to dose due to a lack of concentration data, which may result in an acute kidney injury that can kill patients.
When dosing vancomycin, clinicians monitor two things – the drug concentration itself and creatine, a biomarker of kidney health. This is currently done through a blood draw sent to a lab, with results returning hours later.
During this time, the concentration of the drug will change, so clinicians must estimate whether to up the dose or not.
“They’re always looking in the rear-view mirror,” says Vranes. “They do their best, but the outcomes are sometimes poor because they just don’t know.”
The DNA-based sensor, however, has the capability to monitor both the patient’s vancomycin concentration and creatine levels in real time.
This allows clinicians to titrate, or adjust, the medicine to reach a “therapeutic zone” – where the bacteria get killed, and risk to the patient is minimised.
“The clinical decision is far enhanced by providing guidance to get patients into the therapeutic zone and keep them out of the toxic zone,” adds Vranes.
Looking forward
Following clinical trials and approval by the Food and Drug Administration (FDA), the device is expected to be commercially available in 2028.
After multiplexing the device in ICU, which makes it possible for several input signals to share one device, the plan is to move the Nutromics DNA-based sensor to the general ward, followed by remote patient monitoring.
The ultimate goal, however, is a direct-to-consumer product to prevent patients from entering hospital in the first place.
“Because we can multiplex, we can just add another sensor on the end of a micro needle and that is a new product,” says Vranes. “Where we want to get to is hundreds of sensors on a patch.”
The notion of waiting for a symptom to present before we get it checked out is both “archaic” and “problematic”, says Vranes, given that diseases are often present in the body for months or even years beforehand.
When you can monitor many diagnostic targets continuously, you then have the capability to produce massive data sets.
“Right now, we have a lack of high-quality data sets to make discoveries using AI,” he says. “With an enormous biological data set, we can then interrogate that to make discoveries around early biomarkers of disease states.”
This is not something Nutromics will do in isolation. “We’re already partnering with universities and researchers around the world, including The University of Sydney, to open up our platform as an enabling technology, allowing them to accelerate those discoveries.”
Nutromics is also in early-stage discussions with pharmaceutical companies to assist clinical trials.
“Imagine you’ve got a 1,000-person clinical trial, and all the participants have to go in for blood tests on a regular basis to [generate] data on the drug, safety markers and markers of efficacy,” he says.
“If they had a patch, that would not only reduce their costs, but also give them 1,000 times more data to [enhance] their insights.”
But getting the technology to this place is a long-term goal.
“We see it like a staircase,” says Vranes. “Each step of the staircase solves an unmet critical need, but it’s all leading to prevention.”