Great Basin C. difficile diagnostic assay gets FDA approval
The US Food and Drug Administration (FDA) has granted approval for Great Basin's molecular diagnostic test for Clostridium difficile (C. diff).
The integrated cartridge system enables accurate and information-rich detection of infectious diseases, allowing providers to diagnose and define a clear treatment path for improved patient outcomes and shorter hospital stays.
The aim of the company is to deliver assays that can be performed in a CLIA-rated, waived or moderately complex laboratory at a lower cost than other molecular diagnostic solutions.
Ryan Ashton, Great Basin CEO and president, said the FDA clearance of the C. diff assay will give healthcare providers access to a molecular test that improves workflow at reduced costs.
"Great Basin is focused on developing cost-effective tests that markedly change the way clinicians diagnose the most virulent HAIs, with enhanced ease-of-use and by providing more answers per assay," Ashton added.
"This year we intend to augment our menu offering and have plans to initiate clinical trials for both a broad-panel sepsis and a fungal pathogens assay."
The company is also introducing the assay as a European CE-IVD product under the European Directive 98/79/EC on in vitro diagnostic medical devices, and has initiated marketing the C. diff assay in the EU.
According to Centers for Disease Control and Prevention, C. diff is one of the most common and deadly hospital-acquired infections (HAIs), impacting approximately 700,000 people in the US annually.
Great Basin develops chip-based technologies for the molecular, rapid diagnostic testing market.
Image: C. difficile colonies on a blood agar plate. Photo courtesy of: CDC/Dr. Holdeman.