Instead of waiting for cultures and plate counts, soon iCubate DNA assays could be telling you exactly what gram positive bacteria you are fighting.
The iCubate iC-GPC Assay developed in Huntsville has passed beta testing in three U.S. hospitals with flying colors, and following clinical trials for FDA approval, it could be available for use in patient care within a year.
“With one blood sample, the assay can test for multiple molecular targets and for antibiotic resistance. It enables physicians to ask better questions—not simply ‘Is this germ there,’ but which germs are there, and is there resistant DNA that would make a particular drug ineffective,” iCubate founder Jian Han, MD, PhD, said.
“Instead of having to guess what pathogen is present and which antibiotic to use, then wait two to three days to see if you guessed right, you’ll have an answer within hours,” Han said. “This not only saves the cost of ineffective antibiotics and time when a patient’s condition could be declining—it could save thousands of dollars in extra days of hospitalization and patients can be getting better and going home faster.”
Designed for simple setup, the closed-system consumable cassette also helps to reduce the risk of aerosolization of potentially infectious organisms and amplicon contamination.
Details of the high levels of efficacy demonstrated in beta testing were reported in the Journal of Clinical Microbiology. The assay showed sensitivity of over 93 percent and specificity of 98-100 percent in detecting gram positive bacteria, including staph infections, MRSA and the four pathogens responsible for 90 percent of gram positive bloodstream infections.
A molecular diagnostic company with a novel multiplex polymerase chain reaction (mPCR) technology, iCubate is housed on the campus of HudsonAlpha Institute for Biotechnology. CEO of the company, Carter Wells, is also vice president for economic development at HudsonAlpha and responsible for recruiting promising biotech companies to Huntsville.
“When HudsonAlpha labs and associate companies come together, we are able to accelerate laboratory research into real-world applications,” Wells said. “The culture of collaboration at HudsonAlpha is what makes us one of the most cutting-edge innovation centers in the nation.
“The findings of high efficacy for our iC-GPC assay are an important milestone for iCubate. We are one step closer to having this product available to help healthcare providers better treat their patients.”