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FDA Clears iCubate System, Bloodstream Infection Assay

Molecular diagnostics company iCubate announced the US Food and Drug Administration has cleared its iC-System and iC-GPC assay for the rapid detection of pathogenic bacteria associated with bloodstream infections.

The system is based on iCubate's amplicon-rescued multiplex PCR technology, which detects multiple pathogens simultaneously. iC-GPC Assay is a multiplexed, in vitro diagnostic test for identifying potentially pathogenic bacteria and clinically significant resistance markers to help in diagnosing bloodstream infections. It is the first assay from iCubate to receive FDA clearance, the firm said.

It added that the system and assay provides test results up to 48 hours faster than conventional methods. Detecting bloodstream infections with conventional microbiology methods can take between two to four days, iCubate said.

The iC-GPC assay identifies five of the most common gram-positive organisms associated with gram-positive bacteremia, including Staphylococcus aureus. It also identifies three clinically relevant antibiotic resistance markers specific to methicillin-resistant Staphylococcus and vancomycin-resistant Enterococcus.

"Improved patient treatment through personalized diagnostics is the key mission of iCubate," said company founder and chief scientific officer Jian Han. "The iCubate assay provides a new tool to physicians that will allow for improved patient management through the rapid identification of bacteria and resistance markers, which accomplishes that goal."

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