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AdvanDx’s mecA XpressFISH assay receives FDA approval

Molecular diagnostic products developer AdvanDx has received 510(k) approval from the US Food and Drug Administration (FDA) for its new mecA XpressFISH assay.

The assay has been developed to detect methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA & MSSA) direct from blood culture samples.

AdvanDx R&D and business development senior vice-president Geoffrey McKinley said: "mecA XpressFISH detects and identifies expression of the gene which will help clinicians determine if the infection is resistant to commonly used, well tolerated drugs.

"The test will guide caregivers to the best course of antibiotic treatment, discontinuing the use of broad spectrum antibiotics for patients with routine Staphylococcus aureus infections."

According to the company, the assay uses peptide nucleic acid (PNA) probes to bind and detect mecA messenger RNA (mRNA) sequences in blood cultures from patients infected with Staphylococcus aureus.

AdvanDx has three product families, including 90-minute pathogen ID PNA FISH, 20-minute pathogen ID QuickFISH, and 70 minute mecA resistance ID XpressFISH.