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AdvanDx Secures FDA Clearance for Faster Candida Test Protocol

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Molecular diagnostics company AdvanDx announced today that it has received 510(k) clearance from the US Food and Drug Administration for a rapid version of its Yeast Traffic Light PNA FISH test — a method for detecting several species of yeast that can cause hospital-acquired infections.

AdvanDx's Candida yeast detection method, which relies on a combination of fluorescence in situ hybridization and peptide nucleic acid probes targeting specific ribosomal RNA, can identify as many as five Candida species from blood cultures.

The previous Yeast Traffic Light PNA FISH protocol took about two-and-a-half hours. But by cutting the PNA probe hybridization time by two-thirds, the company is now providing a 90-minute protocol test.

According to AdvanDx, the streamlined test has been clinically validated at US hospitals through comparisons with both their original PNA FISH protocol and with other identification methods.

Infections with Candida yeast can cause serious bloodstream infections, especially in individuals with compromised immune systems. Consequently, being able to accurately detect and identify Candida species is particularly important for knowing how to treat hospital-acquired infections appropriately.

By discerning between several Candida species, the Yeast Traffic Light PNA FISH test can help health care workers narrow in on the most suitable treatment, since Candida species show a range of antifungal drug responses and resistance.

With FDA clearance in place for AdvanDx's more rapid PNA FISH test, "[h]ospitals can now obtain accurate, actionable species identification results for the most common bloodstream pathogens in just 90 minutes," AdvanDX President and CEO Thais Johansen said in a statement, "enabling clinicians to improve antimicrobial therapy, care, and outcomes for their patients."