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

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Genera Biosystems said this week that the Australian Therapeutic Goods Administration has approved its PapType human papillomavirus test kit for inclusion in the Australian Register of Therapeutic Goods.

PapType is a PCR-based assay, which uses Genera's AmpaSand beads as "microscale platforms upon which DNA hybridization events can occur," the company said. Binding events on the beads are read by flow cytometer.

PapType is used to detect and genotype high-risk and low-risk types of HPV. DNA extracted from cervical specimens undergoes two simultaneous PCRs — one using a primer set that amplifies the target HPV DNA of interest, and one that amplifies a human-specific gene that codes for the cardiac isoform of the alkali myosin light chain protein.

Australian healthcare provider Healthscope is already offering PapType for sale through an existing agreement, the company said.

The company also announced that it has completed a repeatability and reproducibility study for PapType with its partner Sonic Healthcare.

The study was designed to demonstrate that PapType performed equivalently between different operators, different laboratories, and at different times. Genera said that the product "comfortably exceeded its targeted study endpoints of 95 percent repeatability and reproducibility."


OncoVista Innovative Therapies said this week that TATAA Molecular Diagnostics will use the Adnatest BreastCancer assay developed by OnmcoVista's AdnaGen subsidiary in an international breast cancer research project called COHERTA.

TATAA Molecular Diagnostics and the Institute of Biotechnology of the Czech Academy of Science are conducting the study with an undisclosed amount of funding from the Czech and Slovak subsidiaries of Hoffmann-La Roche. It will be conducted in the Czech Republic and Slovakia and is expected to take three years to complete.

The COHERTA study will assess the ability of the PCR-based AdnaTest assay to monitor circulating tumor cells to identify HER2-related metastases. The study will evaluate the relationship between the HER2 status of metastatic tumors and the HER2 status of CTCs using assay.