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Dx Focus: BioFire Diagnostics, Roche, Cepheid, BD Diagnostics, Diagenode


The US Food and Drug Administration has approved BioFire Diagnostics' FilmArray Blood Culture Identification Panel. BioFire said that the 27-target panel is the most comprehensive blood culture test to be approved by the FDA.

Requiring only two minutes of hands-on time, the panel can identify more than 100 blood pathogens known to cause sepsis, and can identify a pathogen in nine out of 10 positive blood cultures in about an hour. It 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 pneumonia, 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.

The FilmArray platform integrates sample preparation, amplification, detection, and analysis. It performs PCR to initially amplify nucleic acids from target pathogens, and uses melt curve analysis for multiplexed detection.

The BCID Panel received CE marking earlier this month (PCR Insider, 6/6/2013).

Roche said this week that the FDA has approved a new, more efficient workflow process for the Cobas HPV test.

The newly approved workflow allows sample processing from the primary sample collection vial after it has been used for cytology testing. This allows labs to load the same vial used for a ThinPrep Pap test directly onto Roche's Cobas 4800 System for high-risk human papillomavirus and individual HPV 16 and 18 genotype testing, which is used to help identify women at risk for cervical cancer.

Cepheid has received FDA clearance to market its Xpert MRSA/SA Blood Culture test on the GeneXpert system for the detection of methicillin-resistant Staphylococcus aureus and S. aureus in blood culture bottles.

Cepheid's updated Xpert MRSA/SA BC test processes positive blood culture specimens to determine if a patient's blood is infected with MRSA or SA, which are frequent causes of sepsis in hospitalized patients.

"Having the capability to differentiate MRSA, S. aureus, and [coagulase-negative staphylococci] rapidly in blood culture specimens is a major responsibility of the clinical laboratory. The clear advantage of the three-target detection algorithm in the Xpert MRSA/SA BC test is the direct identification of both MRSA and S. aureus in approximately one hour," Fred Tenover, Cepheid's vice president for scientific affairs, said in a statement.

BD Diagnostics, a segment of Becton Dickinson, and Diagenode this week announced the CE marking and European launch of the Diagenode Bordetella pertussis/parapertussis real-time PCR kit for use on the BD MAX system using the BD MAX ExK DNA-1 Extraction Kit.

BD MAX is a fully automated molecular diagnostics system that standardizes the extraction process and can be used with commercial diagnostic kits or laboratory-developed tests.

B. pertussis is responsible for 30 million to 50 million cases yearly of the highly contagious respiratory disease commonly referred to as pertussis or whooping cough. Timely detection through PCR is essential in preventing the spread of disease and reducing the risk of widespread outbreaks. PCR testing is ideal in enabling the prompt differential diagnosis of pertussis from other respiratory diseases such as atypical pneumonia, bronchitis or respiratory viruses, BD Diagnostics said.