Skip to main content

AdvanDx Gets FDA OK for Faster Staphylococcus Dx

NEW YORK (GenomeWeb News) – Molecular diagnostics firm AdvanDx said today that it has received US Food and Drug Administration clearance for faster versions of its Staphylococcus aureus and S. aureus/coagulase-negative Staphylococci diagnostic tests.

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

Since 2003, the use of PNA FISH to rapidly identify staphylococcal bloodstream pathogens has drastically improved therapy decisions and outcomes for patients with bloodstream infections by providing results in hours, instead of days, helping physicians and pharmacists optimize antibiotic therapy earlier, AdvanDx said.

The 90-minute PNA FISH protocol should enable laboratories to further improve turn-around times, thereby helping clinicians further improve antibiotic selection, care, and outcomes for patients with staphylococcal bloodstream infections, the company said.

According to AdvanDx, clinical validation studies performed at various US hospitals have demonstrated that the 90 minutes protocol demonstrates the same sensitivity and specificity as slower, conventional tests.

In October, AdvanDx received FDA clearance for a 90-minute version of its PNA FISH test for the bloodstream pathogen Enterococcus faecalis.

The Scan

Pfizer-BioNTech Seek Full Vaccine Approval

According to the New York Times, Pfizer and BioNTech are seeking full US Food and Drug Administration approval for their SARS-CoV-2 vaccine.

Viral Integration Study Critiqued

Science writes that a paper reporting that SARS-CoV-2 can occasionally integrate into the host genome is drawing criticism.

Giraffe Species Debate

The Scientist reports that a new analysis aiming to end the discussion of how many giraffe species there are has only continued it.

Science Papers Examine Factors Shaping SARS-CoV-2 Spread, Give Insight Into Bacterial Evolution

In Science this week: genomic analysis points to role of human behavior in SARS-CoV-2 spread, and more.