Press Release
| Asuragen and Life Technologies Launch CE-Marked BCR/ABL1 Quant(TM) Leukemia Test in Europe |
AUSTIN, Texas & CARLSBAD, Calif., Jul 13, 2010 (BUSINESS WIRE) -- Asuragen, Inc. and Life Technologies Corporation (NASDAQ: LIFE) announced today that they have achieved CE-marking and commercial launch in Europe of the BCR/ABL1 Quant(TM) Test, Asuragen's clinically validated and cGMP manufactured test intended to aid clinicians in the monitoring and treatment of individuals afflicted with chronic myeloid leukemia (CML). Asuragen manufacturers the monitoring test, which is exclusively distributed by Life Technologies and runs on the company's Applied Biosystems CE-marked 7500 Fast Dx Real-Time PCR Instrument(TM). The CE-marked BCR/ABL1 Quant Test for leukemia progression is a quantitative in vitro diagnostic test to help doctors determine the most effective treatment options for CML. The test monitors the BCR-ABL1 to ABL1 ratio by reverse transcription quantitative polymerase chain reaction (RT-qPCR) on whole blood or bone marrow of diagnosed Philadelphia chromosome positive chronic myeloid leukemia (CML) patients expressing b2a2, b3a2 or e1a2 fusion transcripts. The test is intended as an aid in the assessment of complete cytogenetic response (CCyR), major molecular response (MMR), minimal residual disease and relapse in CML patients. "The BCR/ABL1 Quant Test provides several advantages over current methods by enabling multiplex detection of all targets in a single reaction and providing unmatched standardization through the use of our proprietary Armored RNA Quant(R) technology for external calibrators and process controls," said Rollie Carlson, President of Asuragen. "Life Technologies is committed to providing versatile molecular diagnostic platforms which simplify the development of sensitive and specific diagnostic assays, and have the potential to impact the way patients are treated," said Kimberlee Caple, Head of Molecular Medicine Products for Life Technologies. "Using genetic markers such as these to aid clinicians in monitoring disease progression is an important step in the evolution of personalized medicine." The BCR-ABL1 fusion gene arises from a specific chromosome translocation, known as the Philadelphia chromosome or t(9:22). The resulting BCR/ABL1 fusion transcripts are present in approximately 95% of CML. If present, the expression level of the fusion transcript or its ratio to a reference transcript may be used to monitor disease progress. Monitoring the level of BCR/ABL1 may be helpful for both prognosis and management of Gleevec(R), Tasigna(R), Sutent(R) and Sprycell(R) kinase therapies in patients with leukemia disease. Asuragen and Life Technologies have plans to pursue future regulatory clearance for a BCR/ABL1 Quant test in the United States. About Asuragen Asuragen is a fully integrated diagnostic development company and pharmaceutical services provider. The Company's diagnostic product portfolio consists of the first-ever validated microRNA diagnostic assay for pancreatic cancer, quantitative RNA tests for leukemia gene translocations, and the Signature(R) Oncology and Genetic Testing products. Asuragen is empowered with a high level of scientific expertise and assay development capabilities, CLIA and GLP testing services, and an established cGMP manufacturing facility, which allow it to span the spectrum of discovery, testing, production and commercialization. For more information, visit www.asuragen.com. Armored RNA Quant(R) is a registered trademark of Asuragen, Inc. About Life Technologies Life Technologies Corporation (NASDAQ: LIFE) is a global biotechnology tools company dedicated to improving the human condition. Our systems, consumables and services enable researchers to accelerate scientific exploration, driving to discoveries and developments that make life even better. Life Technologies customers do their work across the biological spectrum, working to advance personalized medicine, regenerative science, molecular diagnostics, agricultural and environmental research, and 21st century forensics. Life Technologies had sales of $3.3 billion in 2009, employs approximately 9,000 people, has a presence in approximately 160 countries, and possesses a rapidly growing intellectual property estate of approximately 3,900 patents and exclusive licenses. Life Technologies was created by the combination of Invitrogen Corporation and Applied Biosystems Inc., and manufactures both in-vitro diagnostic products and research use only-labeled products. For more information on how we are making a difference, please visit our website: http://www.lifetechnologies.com. Follow Life Technologies on Twitter @LIFECorporation and on Facebook. Life Technologies Safe Harbor Statement This press release includes forward-looking statements about Life Technologies' anticipated results that involve risks and uncertainties. Some of the information contained in this press release, including, but not limited to, statements as to industry trends and Life Technologies' plans, objectives, expectations and strategy for its business, contains forward-looking statements that are subject to risks and uncertainties that could cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Any statements that are not statements of historical fact are forward-looking statements. When used, the words "believe," "plan," "intend," "anticipate," "target," "estimate," "expect" and the like, and/or future tense or conditional constructions ("will," "may," "could," "should," etc.), or similar expressions, identify certain of these forward-looking statements. Important factors which could cause actual results to differ materially from those in the forward-looking statements are detailed in filings made by Life Technologies with the Securities and Exchange Commission. Life Technologies undertakes no obligation to update or revise any such forward-looking statements to reflect subsequent events or circumstances. Photos/Multimedia Gallery Available:http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6357148&lang=en SOURCE: Asuragen, Inc. and Life Technologies Corporation Asuragen, Inc. |
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