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FDA Clears Faster Versions of AdvanDx Bloodstream Pathogen Tests

NEW YORK (GenomeWeb News) – Molecular diagnostics firm AdvanDx said today that it has received 510(k) clearance from the US Food and Drug Administration for faster versions of its Escherichia coli/Pseudomonas aeruginosa and EK/P. aeruginosa diagnostic tests.

The new versions of the tests, which use peptide nucleic acid fluorescence in situ hybridization, or PNA FISH, provide results in 90 minutes instead of 2.5 hours for conventional tests because PNA probe hybridization is reduced from 90 minutes to 30 minutes, AdvanDx said.

The company also said that clinical validation studies performed at US hospitals have demonstrated 100 percent equivalence between the 90-minute protocol and the original PNA FISH protocol, ensuring that the faster protocol maintains the very high sensitivity and specificity required versus slower methods.

With the introduction of the 90-minute PNA FISH protocol, laboratories will be able to further improve turnaround times for critical results and help clinicians improve pseudomonal versus non-pseudomonal antibiotic selection for patients with Gram-negative bloodstream infections, AdvanDx said.

Earlier this month, AdvanDx said that it had received FDA clearance for a 90-minute version of its PNA FISH tests for Staphylococcus aureus and S. aureus/coagulase-negative Staphylococci; and in October, the company received clearance for a 90-minute version of its Enterococcus faecalis test.

"We are very excited to continue the speedy transition of our PNA FISH tests to the 90 minutes protocol in the United States," AdvanDx President and CEO Thais Johansen said in a statement. "The FDA clearances ... bring AdvanDx a step closer to providing accurate and actionable results in just 90 minutes for the most critical bloodstream pathogens."