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Dx Focus: Clinical and Regulatory PCR and Nucleic Acid Testing News: Oct 28, 2010


Roche said this week that its real-time PCR Cobas TaqMan HCV test, v2.0, has received US Food and Drug Administration approval.

Designed for use with the High Pure System viral nucleic acid kit, the Cobas TaqMan HCV Test 2.0 is intended to quantify the amount of hepatitis C viral RNA in human plasma or serum of HCV-infected individuals. The test incorporates a manual specimen preparation and the Cobas TaqMan 48 Analyzer for automated amplification and detection. Roche said that it now offers HCV viral load testing with both manual and automated sample preparation methods.

"This HCV quantitative test is key to measuring the effectiveness of many antivirals that are currently in clinical development for the treatment of hepatitis C," Teresa Wright, chief medical officer of Roche Molecular Diagnostics, said in a statement.

Molecular Detection said this week that Dutch life sciences and diagnostic distributor Westburg BV will distribute the MDI Detect-Ready MRSA panel in the Benelux region under an exclusive agreement.

MDI also noted that it has renamed its test the Detect-Ready MRSA panel from the Detect-Ready MRSA assay because the product is now CE-marked in the European Union to detect methicillin-resistant Staphylococcus aureus, methicillin-sensitive S. aureus, methicillin-resistant non-S. aureus, and mixed samples, which are frequently encountered in clinical practice.

MDI's Detect-Ready MRSA is a qualitative real-time PCR-based test to detect MRSA nasal colonization. The test kits are off-the-shelf, room temperature-stabilized, and compatible with multiple RT-PCR platforms including the Roche LightCycler, Qiagen Rotor-Gene, and Cepheid SmartCycler. MDI has previously inked distribution deals for the test in Germany, the UK, Spain, Ireland, Switzerland, Austria, and Australia.

Epigenomics said today that biomedical distributor Dateks will market Epigenomics' Epi proColon colorectal cancer test in Turkey.

Epi proColon is a DNA methylation-based test that detects colorectal cancer in blood plasma by identifying the methylated Septin 9 biomarker.

Epigenomics currently markets Epi proColon directly in Germany, Austria, and Switzerland. Earlier this month, the German firm named Pronto Diagnostics as an exclusive distributor of the test in Israel (PCR Insider, 10/14/10); and said that it had inked a global manufacturing contract covering Epi proColon with US-based life science outsourcing firm NextPharma (PCR Insider, 10/7/10).

The Scan

Researchers Develop Polygenic Risk Scores for Dozens of Disease-Related Exposures

With genetic data from two large population cohorts and summary statistics from prior genome-wide association studies, researchers came up with 27 exposure polygenic risk scores in the American Journal of Human Genetics.

US Survey Data Suggests Ancestry Testing Leads Way in Awareness, Use of Genetic Testing Awareness

Although roughly three-quarters of surveyed individuals in a Genetics in Medicine study reported awareness of genetic testing, use of such tests was lower and varied with income, ancestry, and disease history.

Coral Genome Leads to Alternative Amino Acid Pathway Found in Other Non-Model Animals

An alternative cysteine biosynthesis pathway unearthed in the Acropora loripes genome subsequently turned up in sequences from non-mammalian, -nematode, or -arthropod animals, researchers report in Science Advances.

Mosquitos Genetically Modified to Prevent Malaria Spread

A gene drive approach could be used to render mosquitos unable to spread malaria, researchers report in Science Advances.