News | June 03, 2008

AdvanDx Submits Rapid Bloodstream Pathogen Detection Platform for FDA Review

June 4, 2008 - AdvanDx this week submitted for FDA 510(k) review its Yeast Traffic Light PNA FISH for detection of Candida yeast species from positive blood cultures.

Yeast Traffic Light is the latest addition to AdvanDx’s easy-to-use, molecular-based PNA FISH diagnostics platform that provides rapid identification of bloodstream pathogens in hours instead of days. Candidemia, a bloodstream infection caused by Candida species is one of the most serious hospital acquired infections, afflicting more than 24,000 patients in the U.S. every year. Immunocompromised transplantation, oncology and AIDS patients are especially at risk for contracting the infection with mortality rates as high as 50 percent. While identification of the infecting Candida species is used to guide effective antifungal therapy, conventional laboratory methods can take up to five days or longer.

The company said its Yeast Traffic Light will for the first time enable laboratories to rapidly detect, in a single test, up to five Candida species directly from positive blood cultures including C. albicans and C. parapsilosis, C. tropialis, and C. glabrata and C. krusei in hours instead of days. The rapid results should enable clinicians to provide early, effective and appropriate antifungal therapy for patients with candidemia.

PNA FISH is an easy-to-use and highly sensitive and specific fluorescence in situ hybridization (FISH) assay that uses PNA (peptide nucleic acid) probes to target species specific ribosomal RNA (rRNA) in bacteria and yeast. PNA FISH tests enable microbiology labs to provide rapid and accurate identification of bloodstream pathogens directly from positive blood cultures in hours instead of days. Clinical studies show that rapid identification of bloodstream pathogens using PNA FISH tests leads to more appropriate patient therapy that saves lives and reduces unnecessary antibiotic use, patient length of stay and hospital costs.

For more information: www.AdvanDx.com

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