AdvanDx Receives FDA 510(k) Clearance for GBS PNA FISH(R) for Rapid Detection of Group B Strep from ...(some true positive samples.(3) GB...),Health

GBS PNA FISH combines the high sensitivity of Lim Broth with the speed, accuracy and ease-of-use of the PNA FISH molecular diagnostic platform to provide accurate Group B Strep detection fit for the routine laboratory workflow. In a recent clinical study, GBS PNA FISH was shown to detect up to 42% more Group B Strep positives than conventional culture methods. The authors of the study also found that the test produced results 2 to 3 days faster and concluded that "use of the PNA FISH assay for the detection of GBS from Lim broth culture showed an increased sensitivity, required decreased specimen handling, and had a shorter turnaround time than culture."(1)

"GBS PNA FISH brings another exciting application to the PNA FISH platform and is another critical tool for improving infection prevention and patient management," said Thais T. Johansen, President and CEO of AdvanDx. "The test will enable labs to provide fast and sensitive detection of Group B Strep that in turn may help clinicians provide better preventative care for more pregnant women and their newborns," Johansen added.

About PNA FISH(R)

PNA FISH is an easy-to-use and highly sensitive and specific fluorescence in situ hybridization (FISH) assay that uses PNA (peptide nucleic acid) probes to target species specific ribosomal RNA (rRNA) in live bacteria and yeast. The unique properties of the non-charged, peptide backbone of PNA probes enable the use of FISH assays in exceedingly complex sample matrixes, such as blood and blood cultures, and this in turn facilitates the development of very simple, yet very accurate tests that don't require the extensive sample preparation necessary for other nucleic acid technologies.

PNA FISH tests enable microbiology labs to provide rapid and accurate pathogen identification in hours instead of days. Clinical studies show that the significa
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