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Sep 1, 2009 (Vol. 29, No. 15)

Changing the Face of Clinical Medicine

Novel Technologies Take Aim at the Astronomical Cost of Healthcare

  • Real-Time PCR with FDA Approval

    Applied Biosystems, also a division of Life Technologies, presented the 7500 Fast Dx Real-Time PCR Instrument, a flexible, medium-throughput device, designed to facilitate assay development on an in vitro diagnostic platform.

    The instrument is devised to meet current health challenges to the identification of influenza strains, especially the strain associated with the recent outbreak of the H1N1 virus (swine flu), according to a Life Technologies official. The FDA has authorized the emergency use of a new CDC rRT-PCR detection panel for the swine flu with instructions that the assay be performed on an Applied Biosystems 7500 instrument.

    The company has formed a special 24/7 task force to coordinate the company-wide response to requests for assistance with the outbreak. The task force provides health agencies with support, including instrument training, supply chain management, and monitoring regulatory compliance. The company has also accelerated the manufacture of components that will be used by laboratories to test for and identify influenza.

    Other products of relevance to management of a possible H1N1 outbreak include the MagMAX™ viral RNA isolation kits, the SuperScript® III Platinum® One-Step qRT-PCR kit, TaqMan® influenza A detection kit, and several different capillary electrophoresis systems for determining the base-by-base sequence of viral samples.

    Last September, the 7500 Fast Dx instrument received 510(k) clearance from the FDA for use with the CDC Human Influenza Virus Detection and Characterization Panel (rRT-PCR Flu Panel). Both products are required to be used together as a system for the detection of influenza.

  • Stabilizing Tissues

    Click Image To Enlarge +
    Assay performed using Dako's HercepTest and according to manufacturer with sections from mirrored samples of HIDC of the human breast, treated with PAXgene Tissue from PreAnalytiX: x100(A), x400(B).

    “Tissue over- and underfixing, crosslinking of biomolecules and lack of standardization can lead to loss of morphology and poor quality histological preparations,” according to Lynne Rainen, Ph.D., scientific director at PreAnalytiX, a Qiagen/BD company. Dr. Rainen discussed her company’s PAXgene tissue system, which is designed to overcome the drawbacks of conventional tissues processing. 

    The PAXgene tissue system’s first step involves the use of a special container for fixation and stabilization of the tissues under a standardized set of conditions. This allows the formalin-free preservation of nucleic acids along with the histomorphology of the tissues. Dr. Rainen argues that there are marked advantages to her company’s technology.

    “It provides details of the histology comparable to classic H&E staining, it is compatible with immunohistochemical applications, it preserves DNA for PCR-based applications, and it allows purification of all nucleic acids from one sample,” she said.

    Whereas standard fixation technologies may allow PCR amplification to take place, the company’s studies have shown much better PCR response with the PAXgene system, Dr. Rainen noted. She said that the system is particularly effective at copurification of small RNAs. 

    “The excellent preservation of RNA samples means that the system can be used for quantitative downstream measurements of message content in tissues, enabling molecular pathology testing at a level of accuracy not previously attainable,” Dr. Rainen concluded.

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