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AdvanDx Files with FDA for Clearance of Hospital Infection MDx Test

Jun 04, 2008
NEW YORK (GenomeWeb News) – AdvanDx has filed for 510(k) clearance from the US Food and Drug Administration for a molecular test that can detect an infectious yeast in blood cells. 
 
The company’s Yeast Traffic Light PNA FISH test detects up to five Candida yeast species from positive blood cultures in hours, rather days, AdvanDx said.
 
When it gets into the bloodstream, this yeast can cause Candidemia, which is frequently a hospital-acquired infection that affects over 24,000 US patients each year.
 
"The test will ultimately enable clinicians to provide more appropriate care, improve antifungal selection and hopefully improve outcomes for their patients," said AdvanDx CEO Thais Johansen in a statement.
 
The PNA FISH technology is an in situ hybridization assay that uses peptide nucleic acid probes to target species-specific ribosomal RNA in bacteria and yeast.

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