A small rectangular, paper card, along with an accompanying software suite, may be the start of a revolution in patient diagnostics.
Group K Diagnostics has developed a fast and affordable microfluidic device called the MultiDiagnostic. A clinician or hospital employee, such as a medical assistant or nurse, applies the patient’s blood from a fingerstick to the paper card and within 20 minutes or less results are back without the wait, expense, and inconvenience of sending a blood sample to an off-site lab.
The software suite has a number of valuable features, such as epidemic tracking, inter-hospital record keeping and tracking, and a patient portal so patients have more control of their health. It is what also holds the company-developed algorithm that translates the color change on the device to quantitative lab results comparable to those found in the standard of care.
Down the line, the company plans to offer further on-site diagnostic tools using urine, saliva or a swab.
“With a 20 minute or less turnaround time, the MultiDiagnostic point-of-care test and accompanying software platform gives patients direct access to their results and allows providers to take immediate therapeutic action based on reliable results,” explained Brianna Wronko, CEO and founder of Group K Diagnostics, in announcing the new technology. “The MultiDiagnostic’s affordable price point and ease-of-use break down the barriers of access to POC testing so that all outpatient providers and patients can benefit from the streamlined workflow,” Wronko continued.
“While working in HIV care, I saw the need, and potential, of getting rapid results from diagnostic testing. A simple and affordable test could mean a revolutionary improvement in patient outcome in a variety of circumstances,” said Wronko.
The system can test for multiple factors at once, allowing physicians to order their standard array of tests. There is also a barcode identifying the patient, to better ensure transfer of results to the electronic health record.
Another feature allows medical professionals to gather geographic information to track disease spread. That could be a big deal in helping to prepare for or even head off a potential epidemic.
Wronko brings seven years of research experience in microfluidics and immunology to the design and manufacture of the paper and software. She has a Bachelor of Science and Engineering from the University of Pennsylvania School of Engineering and Applied Sciences, with years of research in microfluidics and experience with the FDA approval process. She has been instrumental in streamlining the pre-clinical, clinical and future FDA approvals. Group K was also part of the Spring 2017 Dreamit Health cohort and has an extensive scientific advisory board comprised of members from the Ichan School of Medicine at Mt Sinai, PennMedicine, and Harvard.
According to Wronko, most clinical decisions are made based on lab results, but it can sometimes be days before lab results are returned. Often, patients are never contacted about abnormal results. Getting fast, reliable information at the point-of-care makes good sense for patients.
It also is far more economical than lab results. The test runs $8 to $12, instead of up to $100 per test for lab results.
The product could also make a big difference for the practice of medicine in remote or socioeconomically challenged areas, where it might be very difficult or even impossible to get a sample to a lab and receive results quickly.