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Dx Focus: Clinical and Regulatory PCR and Nucleic Acid Testing News: Sep 23, 2010


The US Food and Drug Administration has cleared for marketing Roche Molecular Diagnostics' second-generation Cobas AmpliPrep/Cobas TaqMan HBV test.

The molecular test quantitatively detects hepatitis B virus DNA in human plasma or serum for patients on hepatitis B virus antiviral therapy. The test runs on a platform that combines automated sample preparation on the Cobas AmpliPrep with automated real-time PCR amplification and detection on the Cobas TaqMan Analyzer or smaller Cobas TaqMan 48 analyzer.

The newest version of the test uses a reduced sample input volume of 650 µL of either serum or plasma specimens and is standardized against the World Health Organization standard for hepatitis B, according to Roche.

Molecular Detection said this week that Sydney, Australia-based Integrated Sciences will exclusively distribute Molecular Detection's Detect-Ready MRSA assay in Australia.

MDI's Detect-Ready MRSA is a qualitative real-time PCR-based test to detect methicillin-resistant Staphylococcus aureus 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, Molecular Detection said.

The Detect-Ready MRSA assay kit already has CE mark certification for sales in the European Union, and MDI currently sells the test in Germany, the UK, Spain, Ireland, Switzerland, and Austria.

Celera said this week that Abbott will exclusively distribute Celera's CE-marked real-time PCR-based KIF6 diagnostic test for use on Abbott's m2000 instrument system in the European Union and other areas that recognize the CE mark.

Under the four-year deal, Celera will manufacture the test, which Abbott will distribute in certain markets worldwide, but excluding the US.

Celera filed an application for the CE mark in June for the test, which detects a variant in the KIF6 gene that may be used in conjunction with clinical evaluation and patient assessment to identify individuals at risk for coronary heart disease, and in patients for whom statin treatment is being considered.

Celera's Berkeley HeartLab business currently offers a KIF6 test in the US as a laboratory-developed test.

Outside of the US, Abbott offers several tests for the m2000 system, including for HIV, hepatitis B and C viral load, hepatitis genotyping, cytomegalovirus, Epstein-Barr virus, and colorectal cancer. In the US, the system can run tests for HIV, HBV, chlamydia, and gonorrhea.

The Scan

US Booster Eligibility Decision

The US CDC director recommends that people at high risk of developing COVID-19 due to their jobs also be eligible for COVID-19 boosters, in addition to those 65 years old and older or with underlying medical conditions.

Arizona Bill Before Judge

The Arizona Daily Star reports that a judge weighing whether a new Arizona law restricting abortion due to genetic conditions is a ban or a restriction.

Additional Genes

Wales is rolling out new genetic testing service for cancer patients, according to BBC News.

Science Papers Examine State of Human Genomic Research, Single-Cell Protein Quantification

In Science this week: a number of editorials and policy reports discuss advances in human genomic research, and more.