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Dx Focus Jul 15, 2010: Clinical and Regulatory PCR and Nucleic Acid Testing News


Asuragen and Life Technologies said this week that they have received the CE mark for Asuragen’s BCR/ABL1 Quant test and commercially launched the assay in Europe.

The test, manufactured by Asuragen and exclusively distributed by Life Technologies, is intended to aid clinicians in monitoring and treating individuals with chronic myeloid leukemia. The test runs on Life Tech’s Applied Biosystems CE-marked 7500 Fast Dx Real-Time PCR instrument.

Specifically, BCR/ABL1 Quant is a quantitative in vitro diagnostic test that monitors the BCR-ABL1-to-ABL1 ratio by quantitative PCR on whole blood or bone marrow of diagnosed Philadelphia chromosome-positive chronic myeloid leukemia patients expressing b2a2, b3a2, or e1a2 fusion transcripts.

The test is intended as an aid in assessing complete cytogenetic response, major molecular response, minimal residual disease, and relapse in CML patients.

Asuragen and Life Technologies said that they plan to pursue regulatory clearance for a BCR/ABL1 Quant test in the US.

Barcelona-based Palex Medical will exclusively distribute Molecular Detection’s Detect-Ready MRSA assay in Spain, the companies said this week.

The Detect-Ready MRSA assay kit is a qualitative, real-time PCR in vitro diagnostic test to directly detect methicillin-resistant Staphylococcus aureus nasal colonization and aid in preventing and controlling hospital-based infections.

According to Molecular Detection, the Detect-Ready assay uses proprietary technology that provides a "differential diagnosis engine" that minimizes false positives and negatives experienced with other MRSA screening assays.

The Detect-Ready kits are compatible with multiple RT-PCR platforms currently found in clinical laboratories, including the Roche LightCycler, Qiagen Rotor-Gene, and Cepheid SmartCycler.

Meridian Bioscience's said this week that it has received clearance from the US Food and Drug Administration for its Illumigene C. difficile molecular amplification assay.

The assay, which amplifies DNA using loop amplification technology, detects the presence of a DNA region common to all toxin-producing strains of C. difficile, and provides results in less than one hour, Cincinnati, Ohio-based Meridian said.

Meridian has previously developed rapid immunoassay-based tests for C. difficile. In a statement, CEO Jack Kraeutler said that the company “some years ago recognized that our infectious disease lab customers may require molecular amplification capabilities in specific instances.”

The Scan

Genetic Risk Factors for Hypertension Can Help Identify Those at Risk for Cardiovascular Disease

Genetically predicted high blood pressure risk is also associated with increased cardiovascular disease risk, a new JAMA Cardiology study says.

Circulating Tumor DNA Linked to Post-Treatment Relapse in Breast Cancer

Post-treatment detection of circulating tumor DNA may identify breast cancer patients who are more likely to relapse, a new JCO Precision Oncology study finds.

Genetics Influence Level of Depression Tied to Trauma Exposure, Study Finds

Researchers examine the interplay of trauma, genetics, and major depressive disorder in JAMA Psychiatry.

UCLA Team Reports Cost-Effective Liquid Biopsy Approach for Cancer Detection

The researchers report in Nature Communications that their liquid biopsy approach has high specificity in detecting all- and early-stage cancers.