A newly signed deal between the Center for Disease Control and Prevention and Group K Diagnostics will set up the federal agency and the Center City diagnostics startup to design an easy-to-use test for the Zika virus.
Over the coming months, the two organizations will work to to transform the CDC’s test tube-based assay (an analytic procedure) for the detection of the virus into a non-invasive, rapid detection test to be quickly performed by clinical staffers in areas without access to lab testing.
No financial details from the deal were disclosed, but the company said the design process will be carried out over the next three to six months.
“With my background in point-of-care diagnostics, I’ve seen first-hand the impact point-of-care testing can have on regions with limited resources, and the potential is truly remarkable,” said Dr. Reshma Rajan, diagnostic engineer at Group K. “Our team is honored to partner on this monumental advancement of point-of-care diagnostics, and we look forward to working with the CDC to bring a new, life-saving technology to market.”
CEO Brianna Wronko told Technical.ly that while there are already available tests for the virus, they are all lab-based. This would be the first point-of-care diagnostics tool that can be easily delivered to patients, especially in hard-to-reach areas.
According to CDC stats, there were 220 cases of Zika virus reported last year in U.S. states and territories. The majority of reports were in Puerto Rico, which in 2016 saw several thousands of cases of the disease.
“The CDC came up with an assay that can be performed at point of care, but the test required too much operator skills so it had to be done at a laboratory setting,” Wronko said. “They needed a microfluidics platform that was easy to use.”
At the end of last year, Group K Diagnostics completed the clinical trials for its liver function inpatient diagnostics test. Its point-of-care device, the MultiNostic, is awaiting FDA approval.
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