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New Releases: Dec 15, 2010

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Ipsogen this week launched of a new line of assays that enable the standardization of quantitative analysis of BCR-ABL Mbcr by calibrating the results on the International Scale.

Ipsogen said that its BCR-ABL Mbcr IS-MMR DX and BCR-ABL Mbcr IS-MMR kits have CE-marking and are already available in Europe and other non-US markets. Research-use-only kits are planned for launch in North America next year.

Standardization of the analysis of BCR-ABL transcripts is increasingly viewed as medically necessary when administering drugs like Gleevec.

Gleevec has been on the market for a decade for the treatment of Philadelphia chromosome-positive chronic myelogenous leukemia, and among oncologists it is already standard practice to molecularly monitor BCR-ABL transcript levels to confirm patients have the disease and to ensure patients aren't relapsing or having a refractory response to treatment. However, there is a lack of standardized procedures and reference materials in leukemia monitoring, which can make it difficult to compare results obtained from different labs.

Ipsogen's IS-MMR product line uses an international reference calibrator, allowing molecular labs to convert BCR-ABL results on the International Scale to ensure the test results are standardized across labs.

The International Scale was first proposed by leukemia researchers at a 2005 meeting to serve as a global standard for detecting and reporting BCR-ABL transcript levels. A paper outlining the standard was published the following year in Blood.

There are other companies developing tools to help standardize the monitoring of BCR-ABL transcript levels. For example, last week, Asuragen entered into an exclusive agreement with Gleevec developer Novartis for the worldwide development of Armored RNA Quant BCR-ABL1 RNA International Scale calibrators and laboratory software reporting tools (PGx Reporter 12/08/10).

Novartis is also working with Cepheid to develop a BCR-ABL gene transcript monitoring test, which it hopes will help doctors more reliably manage Philadelphia chromosome-positive chronic myelogenous leukemia patients treated with Gleevec.

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