According to findings published in "The Journal of Clinical Microbiology," the iCubate iC-GPC assay was proven effective in a hospital setting. The device can identify infections including Staphylococcus. Researchers say these are among the most common bacterial contaminants of blood.
“These findings are an important milestone for the company. We are one step closer to having this product available to help healthcare providers better treat their patients,” says iCubate CEO Carter Wells.
The findings, which were published online and will appear in the journal's December print publication, discussed benefits using the iCubate assay.
"A potential benefit of the iC-GPC assay is the use of a single, closed-system consumable cassette. This enables simplified assay set-up (< 5 min. hands on time) and also aids in reducing the risk of aerosolization of potentially infectious organisms and amplicon contamination. Furthermore, the iC- Processor is capable of random-access processing of up to 4 iC-cassettes simultaneously using an instrument that has a small footprint. Combined, these attributes may positively impact safety, workflow, and throughput when compared to other currently available FDA- cleared molecular platforms and assays for the direct identification of bacteria present in positive blood cultures.”
While this gives the company positive momentum, there is a major hurdle iCubate needs to clear before the assay is used in hospitals -- FDA approval.
iCubate founder and chairman Jian Han, M.D., Ph.D., told Tech Alabama in January 2015 he believes the privately-held company will be worth hundreds of millions of dollars once it obtains an FDA 510(k) clearance.
“Combining the innovative arm-PCR technology pioneered by Han, along with our talented team members, iCubate is positioned for success in this growing market,” Wells explains.
A timetable on FDA clearance is unknown at this time.