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Dx Focus: Clinical and Regulatory PCR and Nucleic Acid Testing News: Mar 2, 2011

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Bio-Rad Laboratories said this week that that its iQ-Check Listeria spp. real-time PCR test kit has received Health Canada approval for detection of Listeria spp. in environmental samples.

The iQ-Check Listeria spp. method involves a single 24-hour primary enrichment, comprising a one-step DNA extraction and subsequent PCR amplification. Results are available in approximately two hours, Bio-Rad said. The test is compatible with Bio-Rad's 48-well MiniOpticon and the 96-well CFX96 real-time PCR detection system, for low- and high-volume labs, respectively.

The kit, which has already been validated by AOAC in the US and AFNOR/ISO 16140 in France, is also being evaluated in the joint AOAC/Health Canada GovVal program for detection of Listeria from ready-to-eat foods, Bio-Rad said. Completion of that study is expected in the coming months.


Abbott said last week that the CE-marked KIF6 diagnostic test for use on Abbott's m2000 instrument is now available in Europe.

The KIF6 genotyping assay detects a genetic marker that may be used in conjunction with clinical evaluation and patient assessment to identify individuals at risk for coronary heart disease and to treat patients with elevated cholesterol, for whom statin treatment is being considered. Previous research has shown that carriers of the KIF6 risk variant — about 60 percent of the population — have had significantly fewer fatal or nonfatal coronary events from statin therapy, Abbott said.

The KIF6 diagnostic test is manufactured by Celera, which in September licensed exclusive distribution rights to Abbott to market the test for use on the m2000 in the European Union and other areas that recognize the CE Mark. Under the four-year deal, Celera is manufacturing the test for Abbott to distribute in certain markets worldwide, excluding the US, where Celera is marketing the test.


Meridian Bioscience said this week that it has received US Food and Drug Administration clearance for a new pediatric claim for its Illumigene C. difficile molecular amplification test.

The new claim makes Illumigene the only C. difficile test cleared by the FDA for use on children under the age of two, the company said.

Meridian, based in Cincinnati, Ohio, recently completed a clinical study evaluating "a large number of random specimens from patients suspected of having C. difficile disease," and discovered that "approximately 12 percent of these specimens were children under two years of age," CEO Jack Kraeutler said in a statement.

Kraeutler added that the new indication would provide its customers with "a critical tool to help detect and manage this devastating infection in young children."

The Illumigene C. difficile test uses loop amplification technology to detect the presence of a DNA region common to all toxin-producing strains of C. difficile, and provides results in less than one hour with less than two minutes of hands-on time per sample. The test received general marketing clearance from the FDA in July 2010 (PCR Insider, 7/15/10).

The Scan

Steps for Quick Review

The US Food and Drug Administration is preparing for the quick review of drugs and vaccines for the Omicron variant, according to the Wall Street Journal.

Moving Away From Using Term 'Race'

A new analysis finds that geneticists are using the term "race" in their papers less than in years past, as Science reports.

Point of the Program

The Guardian writes that some scientists have called the design of a UK newborn sequencing program into question.

Science Papers Present Multi-Omic Analysis of Lung Cells, Regulation of Cardiomyocyte Proliferation

In Science this week: a multi-omic analysis of lung cells focuses on RIT1-regulated pathways, and more.