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Dx Focus: Clinical and Regulatory PCR and Nucleic Acid Testing News: Oct 6, 2010

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Roche said this week that its Cobas TaqScreen DPX test for use on the Cobas S 201 system is now available with the CE Mark for in vitro diagnostics.

According to Roche, the Cobas TaqScreen DPX is the first IVD test to completely cover all human genotypes of parvovirus B19 (B19V) and hepatitis A (HAV) virus in one assay; and is also the first commercially available nucleic acid testing system for screening blood and plasma for six viruses.

More specifically, TaqScreen DPX uses multi-dye, real-time PCR to simultaneously quantify B19V genotypes 1, 2, and 3 DNA; and detect HAV genotypes I, II, and III RNA in individual samples or pooled plasma samples of human origin.

Roche said that the test can help manage the B19V burden in plasma pools and identify HAV-contaminated units. It also allows plasma manufacturers to increase processing efficiency, and may reduce the number of units that are discarded.


Qiagen this week announced the launch of EGFR, NRAS, KRAS, and BRAF molecular tests for cancer companion diagnostics CE Marked with the Rotor-Gene Q thermocycler and the PyroMark pyrosequencing system.

The new tests are offered as CE-IVD-marked Therascreen tests in Europe; and as research-use-only tests globally. Qiagen said that CE-marked Therascreen pyrosequencing kits will be available beginning in December. The kits can also be used in combination with Qiagen's QiaSymphony RGQ instrument, which automates the complete testing workflow from sample prep to detection with the Rotor-Gene Q.

Qiagen said that clinicians can use the new tests to identify the presence of certain mutations in the EGFR, NRAS, KRAS, and BRAF genes; and to select and tailor the most appropriate treatments based on that information.


Gen-Probe said this week that it has submitted a 510(k) application to the US Food and Drug Administration for its Aptima Trichomonas vaginalis assay on the company's fully automated Tigris system.

The assay, which has already been CE marked for sale in Europe, is a nucleic acid amplification test to detect T. vaginalis. The assay utilizes the same technology as Gen-Probe's Aptima Combo 2 assay, which uses target capture for the in vitro qualitative detection and differentiation of ribosomal RNA. The Aptima T. vaginalis assay may use the same specimens as those used with Aptima Combo 2, Gen-Probe said. These specimens include vaginal swabs, endocervical swabs, female urine, and PreservCyt solution.

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.