Purdue-developed point-of-care diagnostics and wearables—making the leap out of the lab

The Weldon School of Biomedical Engineering at Purdue University has a rich history and robust focus on innovation and translation of research applied to medical devices implanted within the human body. The school’s faculty members have generated over 100 U.S. patents, with over half licensed to company partners. Biomedical engineering research at Purdue has generated $30 million in licensing royalties, and over 25 startup companies have been founded with more than 3 million patients directly helped.
Jacqueline Linnes, Marta E. Gross Assistant Professor of Biomedical Engineering at Purdue specializes in building portable diagnostic tools that can rapidly detect a range of infectious diseases. She is developing a diagnostic test platform that could be modified for COVID-19 detection.

But an even healthier future will be filled with less invasive, point-of-care medical instruments that detect and even treat disease in the comfort of our homes, as well as wearable devices that continuously monitor chronic conditions and well-being.

The global demand for point-of-care and wearable devices is skyrocketing due to a number of factors including the growing prevalence of such chronic diseases; the popularity of wearables; and the strain on healthcare resources caused by our growing and aging population. Clearly, the current pandemic highlights the urgent need for quick, portable, inexpensive tests.

Weldon School researchers are developing diagnostic devices, patient monitoring, and therapeutic wearables to meet these demands. Jacqueline Linnes, Marta E. Gross Assistant Professor of Biomedical Engineering at Purdue specializes in building portable diagnostic tools that can rapidly detect a range of infectious diseases. She is developing a diagnostic test platform that could be modified for COVID-19 detection. The portable test could be taken at home and would show results in 40 minutes—a potential game-changer in the global pandemic.  Yet the development of such a device that would be used in a variety of settings offers unique challenges.

“Often times the most difficult part is not the invention of the medical device or wearable in the lab, but its refinement through first-in-human and field testing,” said Linnes.  “These ergonomic and scaling challenges require unique resources in order to translate the device into widespread use.”

Linnes certainly knows the investment and effort it takes to do just that. She collaborated with Purdue faculty and an alumna to launch OmniVis LLC, a startup to develop a smartphone test for detecting cholera from water samples to help prevent the spread of the devastating disease. She and her co-founders have worked together with teams in Haiti, Bangladesh, and Kenya to ensure that the test works in the settings for which they were designed, is user-friendly, and meets other criteria established by the World Health Organization for diagnostic tests for resource-constrained settings. The startup has won numerous awards.

“Licensing technologies and starting companies are key ways I’ve found that we can make a device really useful for people. The challenge is to garner the resources to do this on many fronts and do so rapidly in a response to healthcare crises such as a pandemic,” said Linnes.

Her lab has also developed a portable, paper-based device to detect HIV nucleic acids from the blood of a finger prick within 90 minutes. The device was designed for low-resource settings which have fewer lab facilities, may struggle with maintaining a constant power supply to run a facility, and have insufficient clinical staff.  The device developed in the Linnes Lab could be taken at home only a few weeks after an infection and show results that are as easy to read as a pregnancy test. The device is in pre-clinical trials in Kenya and is also being modified for COVID-19 detection.

With startups, patents, and human trials underway, at a glance, Linnes makes translating technology out of the lab look easy, but behind each of those successes were resources that every good idea needs to make that leap. Take the platform that could be used to test COVID-19. One outstanding barrier to developing that test is scaling up and evolving the manufacturing of the device from laborious hand-assembly to large-scale manufacturing.

“In our academic research lab we start out by making things one at a time, mostly. Being able to make 10 or 100 or 1,000 tests at once so that we could perform first-in-human testing more rapidly would really speed things up. It would allow us to create wearable and point-of-care devices at scale.”

The barrier to making that leap? Increased research funding for wearable devices and point-of-care technologies that solve important healthcare needs such as exponentially increasing chronic conditions and infectious disease outbreaks such as from COVID-19.

Linnes is also working with colleagues to develop a glucose diagnostic device that would detect glucose in exhaled breath; it’s a noninvasive monitoring device that could replace the finger prick for millions of patients with diabetes. The research is underway, but Linnes says that the development of new laboratory space that integrates device development and first-in-human testing is required to both scale development and ensure widespread use.

Referring to planned laboratory enhancements in the Martin C. Jischke Hall of Biomedical Engineering, Linnes remarks, “Creating novel capabilities for first-on-human testing would expedite user feedback and optimization of the device.  It would represent a new lab paradigm for translational research in academia.”

Another project underway at the Linnes Lab is the development of warming devices that could keep babies insulated in underserved settings where there are not enough incubators, or where the incubators don’t function optimally in environments with fluctuating power supply. These warming devices support parents and caregivers providing skin-to-skin care, and act as a stop-gap measure to warm babies in between these skin-to-skin care sessions. Linnes is collaborating on this research with Sherri Bucher, associate research professor of pediatrics at the Indiana University School of Medicine

“We are working on the sensing and the heater component of the pouch so that it could act as an incubator for a short period of time while the caregivers are taking a break,” said Linnes. The sensors would provide vital signs monitoring both in the standalone device and during skin-to-skin contact. Linnes is anticipating the stage of research where they will initially test the device on adult humans before it is tested on babies—another example where having a unique laboratory environment at Purdue to readily evaluate new designs would be conducive to quick testing and optimization.  

Point-of-care testing for diseases, glucose monitoring for diabetic patients, the care of our most vulnerable populations—research on devices to support these needs and many more is under way at the Weldon School of Biomedical Engineering. Some of these technologies have been patented and are well on their way in pre-clinical trials. Others could be better served with additional funding, newly developed space and equipment to facilitate evaluation, iteration, and improvement of designs to accelerate bringing these products to patients in need around the world.

If you are interested in learning more about research in point-of-care devices or wearable technologies or in supporting the Weldon School of Biomedical Engineering’s efforts to develop the one-of-a-kind laboratories and instruments to combat major disease challenges, contact Brian Knoy at 765-494-6241 or bjknoy@prf.org.