In This Issue...
Meridian Bioscience Gets FDA Clearance for Mycoplasma Pneumonia Test
Meridian Bioscience, Inc., announced that it has received FDA clearance for a new molecular diagnostic test for Mycoplasma pneumoniae. The Illumigene Mycoplasma test amplifies DNA for the detection of Mycoplasma pneumoniae and circumvents lengthy culturing methods. The test uses both throat and nasopharyngeal swab samples, requires little capital equipment, and relies upon a procedure that takes less than 1 hour.
Often referred to as walking pneumonia, Mycoplasma pneumoniae infections have been associated with up to 40% of community-acquired pneumonias. This is the fourth assay on the company's Illumigene platform.
FDA Approves First HCV Genotyping Test
FDA has approved for the first time a test that identifies the genotype of hepatitis C virus (HCV). The Abbott RealTime HCV Genotype II test, which can differentiate genotypes 1, 1a, 1b, 2, 3, 4, and 5, can aid in determining the appropriate approach to treatment. Because the various HCV genotypes respond differently to available drug therapies, knowing the type of HCV a person is infected with can result in better patient outcomes.
FDA approved the RealTime HCV Genotype II test for individuals known to be chronically infected with HCV. It is not approved for use as either a diagnostic test or as a screening test for the presence of HCV genetic material in blood, blood products, or tissue donors. It also has not been evaluated in newborns or pediatric patients, or in patients with compromised immune systems, such as those with AIDS.
FDA Clears FilmArray Blood Culture Identification Panel
BioFire Diagnostics, Inc., announced the FDA clearance of its FilmArray Blood Culture Identification (BCID) Panel. To date, the 27-target panel is the most comprehensive test to be approved by the FDA.
The FilmArray BCID Panel provides results from positive blood cultures and can identify more than 100 blood pathogens known to cause sepsis. Employing a procedure that only requires 2 minutes of hands-on time, the BCID Panel identifies a pathogen in nine out of 10 positive blood cultures in about 1 hour and is the only test that provides results for gram-positive bacteria, gram-negative bacteria, and yeast that cause bloodstream infections.
In addition, the panel includes the first FDA-cleared diagnostic test for the BLAKPC gene, which is linked to carbapenem resistance in Klebsiella pneumoniae, Acinetobacter spp, and carbapenem-resistant Enterobacteriaceae. The BCID Panel also tests for common antimicrobial resistance genes associated with methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococci.
FDA Clears Updated Xpert MRSA/SA Blood Culture Test
FDA cleared Cepheid's Xpert MRSA/SA Blood Culture (BC) test on the GeneXpert System for detecting methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) in blood culture bottles showing gram-positive cocci in clusters. The expanded FDA clearance for the test allows labs to perform the 1-hour test using blood culture systems and bottles from the top three manufacturers, making the test more widely available to smaller labs.