Brianna Wronko was just 14 years old when she started interning in the chemical engineering department at University of Pennsylvania in Philadelphia.
As a homeschooled student, she was a rising junior in high school at the time and started taking college-level courses at UPenn before officially enrolling in the bioengineering department at 17. She began research in microfluidics, which is the study of manipulating and controlling the behavior of miniscule amounts of fluid as they flow through micro-channels, as well as manufacturing the technologies that contain those channels.
During her time at UPenn, Ms. Wronko also worked at an HIV clinic. It was there she realized a key problem: Patients aren't able to get their lab test results back in an easy and timely manner. It didn't take long to realize this problem wasn't confined to that specific clinic. In fact, physicians in multiple specialties across the U.S. expressed the same concerns with diagnostic testing, and Ms. Wronko soon embarked on an effort to change that.
Her solution was Group K Diagnostics, a student company she founded out of UPenn while completing the final year of her bachelor's degree.
Group K Diagnostics markets a point-of-care testing solution that combines microfluidic technology with software tools to deliver patient test results in just 20 minutes, a fraction of the time traditional methods require.
Becker's Hospital Review caught up with Mr. Wronko to learn more about Group K Diagnostics, its primary product, the MultiDiagnostic, and what's ahead for the startup.
Editor's Note: Responses have been lightly edited for clarity and length.
Question: What is your company's goal? What do you hope to conquer?
Brianna Wronko: Our mission is pretty simple. It is to get cost-effective, time-effective diagnostics to patients where they need them. We do that by producing a modular, point-of-care diagnostic using a paper microfluidic and software technology. Paper microfluidics uses two basic materials — paper and wax — to build a system of hydrophobic, or water fearing, and hydrophilic, or water loving, channels. It can be used in a variety of contexts, one of which can be diagnostics.
Moreover, we were founded as a student company out of UPenn — we still take a lot of interns from UPenn — and our lab team is entirely composed of female engineers, because another part of our mission is to keep innovation alive. I am a female engineer, so it is important to me that we lend a hand to other female engineers.
Q: Your main product is the MultiDiagnostic. Can you explain how it works?
BW: The MultiDiagnostic is essentially a paper microfluidic, so it is using two really common materials: paper and wax. It uses a bunch of chemical reagents to make things like liver function testing and kidney function testing as simple as using a glucometer to test your blood sugar. The way our device works is you touch your finger to the device and 20 minutes later a visible color change happens. We are able to take that visible color change and quantify it using proprietary software on a cell phone. The results are sent directly to the EHR system, as well as to the patient, so not only are patients empowered by knowing their results within 20 minutes, physicians also do not have the burden of calling patients back and releasing results at the end of the day, merely hoping it gets to the patient.
Q: What does Group K Diagnostics have planned next?
BW: We have some exciting months coming. We are moving our lab space to a new location so our offices and labs can be together. Having the lab right next to your administration makes everything flow together and become more creative.
Even bigger than that, we are about to start our first clinical trial at Penn Medicine for our liver function diagnostic, which has a lot of applicability to help many different patient groups. We are really excited that it is our first test. Beyond that, we are putting our next test, a comprehensive metabolic panel, into pre-clinical trials to be the next test we roll out. The comprehensive metabolic panel is a panel that does everything from kidney function to electrolytes to glucose and is one of the most commonly ordered panels in the U.S.
Q: What is the testing process like? And how do you work with the FDA to gain approval for your diagnostics?
BW: Pre-clinical trials take place in our own lab. When we get to clinical trials, we partner with a university. We haven't made a formal partnership yet for the comprehensive metabolic panel, but we have several universities talking to us at the moment.
The clinical space we are in now is highly regulated, and we are really grateful to have that oversight and regulation on us. It ensures we have a second set of eyes to verify we are giving the best care to our patients. We will be going through a 510(K), which is a premarket submission pathway and waiver system that ensures product safety and effectiveness so any test results given to patients are the right test results.
Click here to learn more about Group K Diagnostics.