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Dx Focus Sep 16, 2010: Clinical and Regulatory PCR and Nucleic Acid Testing News


Myconostica this week presented data at the 50th Interscience Conference on Antimicrobial Agents and Chemotherapy from a multi-center prospective evaluation of its PCR-based MycAssay Pneumocystis test for detection of Pneumocystis jirovecii DNA in respiratory samples.

The study, which was carried out in four hospitals in Austria, Switzerland, and the US and involved data from 110 patients, showed that the sensitivity and specificity of the test were 93 percent and 91 percent, respectively, when compared with final clinical diagnosis, Myconostica said.

Fourteen subjects were clinically diagnosed with pneumocystis pneumonia and 13 of these were positive using MycAssay Pneumocystis. "For the 14th subject, the clinical sample was low volume and poor quality, as noted by the site," the company said.

Nine patients without pneumocystis pneumonia had positive MycAssay Pneumocystis results. Of these, on clinical follow up, one subsequently developed PCP. "These results suggest that the increased sensitivity of the molecular assay may be indicative of asymptomatic latent disease in the at-risk patient group," the company said.

Myconostica received CE Marking for MycAssay Pneumocystis last month (PCR Insider 8/12/2010).

Transgenomic said this week that it has launched a CE IVD-labeled version of its Surveyor Scan K-RAS mutation detection kit in the UK, Ireland, Austria, Belgium, Czech Republic, Denmark, France, Germany, Italy, The Netherlands, Poland, Slovakia, Slovenia, Spain, Sweden and Switzerland.

Craig Tuttle, Transgenomic's CEO, said in a statement that the CE IVD label "greatly expands the market for the K-RAS kits, and given our very strong presence in molecular diagnostics laboratories in Europe, we are optimistic about their reception in the commercial setting."

He added that the K-RAS CE IVD kit "is expected to be the first in a line of kits and automated system options offered by Transgenomic," and said the company also plans to roll out similar kits for BRAF, PIK3CA, EGFR, p53 "and a host of other genes involved in cancer."

The Scan

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Study Finds Few FDA Post-Market Regulatory Actions Backed by Research, Public Assessments

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