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Faster results with PNA FISH test

AdvanDx (Woburn, Mass.) has received FDA clearance for its EK/Pseudomonasaeruginosa peptide nucleic acid (PNA) fluorescence in situ hybridization (FISH) assay for the identification of Escherichia coli, Klebsiella pneumoniae, and P. aeruginosa directly from positive blood cultures. It is the first test capable of identifying these bacteria directly from positive blood cultures, and it provides critical results 24 to 48 hours sooner than conventional methods to help clinicians improve care and outcomes for patients with Gram-negative bloodstream infections.


The PNA FISH assay uses PNA probes to target specific ribosomal RNA in live bacteria and yeast. The unique properties of the noncharged, peptide backbone of PNA probes enable the use of FISH assays in very complex sample matrixes, such as blood and blood cultures.

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Luer access valve disinfection cap approved

Excelsior Medical Corporation (Neptune, N.J.) has received clearance from the FDA to market the SwabCap Luer Access Disinfection Cap. SwabCap is designed to assist the healthcare worker and protect the patient by disinfecting their swab-able luer access valve prior to line access in a passive and uniform manner.


The product features a distinctive, patent-pending thread cover design that makes SwabCap an effective cleaning alternative, disinfecting the valve after 5 minutes of application, and acting as a physical barrier to contamination for up to 96 hours under normal conditions if not removed.

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SwabCap was designed to reduce the risk of contamination by simplifying the disinfection process while providing standardization to this critical step in the catheter care process.


Digitized prior film mammograms

Hologic, Inc. (Bedford, Mass.) has received FDA approval for its R2 DigitalNow HD software application, which is the only FDA-approved application intended to process digitized screen-film mammograms for comparison purposes. Hologic collaborated with radiologists to understand the demands of reading digital mammograms when they created the R2 DigitalNow. The software adapts each digitized film image to a selected contrast and tissue intensity that models a digital mammography system. It also can draw out less evident regions of density within digitized films.


The software is designed to enhance workflow by promoting consistency in the digital mammography reading environment. Images already digitized by R2 DigitalNow and stored in PACS can be routed to R2 DigitalNow HD and reprocessed.


Test OK'd for rapid detection of GBS

AdvanDx (Woburn, Mass.) has received FDA clearance for its group B strep PNA FISH assay for the detection of Streptococcus agalactiae (GBS) from turbid Lim Broths inoculated with vaginal and rectal swabs obtained from pregnant women between 35 and 37 weeks gestation. The 90-minute molecular diagnostic test allows rapid and highly sensitive detection of GBS from Lim Broths to help detect colonization in pregnant women. Conventional phenotypic methods for identifying GBS can take anywhere from 3 to 4 days.


A recent clinical study showed that the AdvanDx GBS PNA FISH test was able to detect up to 42% more GBG-positives than conventional culture methods.