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Dx Focus: IdahoTech FilmArray; Curetis Unyvero Pneumonia Assay; IMDx GBS Test; Lab21's US CLIA Lab


The US Food and Drug Administration has given 510(k) clearance for five additional pathogens for Idaho Technology's FilmArray Respiratory Panel, the company said this week.

FDA cleared the FilmArray instrument and panel, a multiplex PCR assay system, for 15 respiratory pathogens a year ago (PCR Insider, 5/5/2011). In February, Idaho Tech said that it would seek clearance for the five additional pathogens that were cleared this week: Bordetella pertussis; Chlamydophila pneumoniae; Mycoplasma pneumoniae; Coronavirus 229E; and Coronavirus OC43 (PCR Insider, 2/2/2012).

The FilmArray Respiratory Panel includes the first FDA-cleared assays for eight of the 20 organisms on it, and is the only FDA-cleared panel that can distinguish between certain bacterial and viral respiratory infections, Idaho Tech said. This latter capability may provide clinical laboratories and doctors with "more comprehensive, actionable information to guide treatment decisions and improve patient outcomes," the company said in a statement.

The company is currently developing other applications for the FilmArray System, including a blood culture ID panel, gastrointestinal pathogens panel, and an STD panel. It expects to start clinical testing of its blood culture ID panel later this year.

Curetis said this week that it has received the CE mark for its Unyvero instrument and P50 pneumonia cartridge, and has commenced commercialization activities in its home country of Germany and in other EU states and countries recognizing CE marking.

The Unyvero platform is a benchtop, nucleic acid testing platform that combines a proprietary universal sample prep method with cartridge-based endpoint PCR and array-based detection. The system features a touchscreen interface with dedicated software and is expected to provide test results in a few minutes' time, according to the company.

Curetis, based in Holzgerlingen, began a clinical trial for the platform and initial P50 pneumonia test in March (PCR Insider, 3/1/2012). It said this week that the test achieved 75 percent sensitivity with better than 95 percent specificity in 186 tested fresh and frozen clinical sputum, aspirate, and bronchial lavage samples. In addition, the test identified 74 additional pathogens missed by standard microbiology culture, which was used as a gold standard comparator in the study.

Curetis said that it has begun directly marketing the Unyvero system to hospitals in Germany, Austria, and Switzerland, and is currently establishing an international distribution network.

IntelligentMDx said this week that it has obtained CE marking for its automated, high-throughput, qualitative in vitro diagnostic test to detect Group B Streptococcus in pregnant women.

The IMDx GBS assay runs on the Abbott m2000 system and detects GBS from both direct swabs and enriched culture broth samples. Results for up to 48 patient samples can be obtained simultaneously in approximately five hours. When compared against traditional culture methods, the IMDx GBS test exhibits 95.5 percent sensitivity and 98.3 percent specificity with direct swabs, and 100 percent sensitivity and specificity with enriched culture broth samples.

The IMDx GBS assay is the third CE-marked test developed under a multi-year distribution agreement between IMDx and Abbott whereby IMDx designs, develops, obtains regulatory clearances, and manufactures assays for the m2000 instrument (PCR Insider, 3/17/2011). The other CE marked assays are for the detection of vancomycin-resistant enterococci and toxigenic Clostridium difficile.

Lab21 said this week that it has begun routine analysis of clinical samples in its CLIA laboratory in Greenville, SC.

The first assays in the test menu include a new human papillomavirus genotyping service using the Roche Cobas 4800 HPV genotyping test to identify high-risk patients and differentiate patients with HPV 16 and HPV 18 genotypes.

Lab21, based in Cambridge, UK, provides molecular diagnostic testing services for oncology and infectious disease. Its services will include KRAS, EGFR, and BRAF mutation analysis; HIV viral resistance; and tropism and viral load assays. Lab21 recently launch its Clinical Genomics Center at ITOR, a hospital-based cancer research organization located in Greenville.