December 18, 2006 “Intelligence: Late Breaking Lab News”

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Last Friday, Luminex Corporation of Austin, Texas announced that it would acquire Tm Bioscience Corp. of Toronto, Ontario. Luminex will pay $44 million, which represents a 41.5% premium for Tm shares based on the December 14 closing price. Tm Bioscience has tests for DNA-based diagnostics, including tests for infectious diseases and genetic mutations related to cystic fibrosis, sepsis, and other disorders. A number of these assays incorporate Luminex’s patented technology.


One area of testing which will be marketed to office-based physicians is quick cholesterol screenings. Promoters see it as a customer-friendly service that can generate additional revenue for physicians. However, experts note that not all instruments produce accurate results. Further, cholesterol testing from a finger stick sample is less preferred to a blood sample tested on a central lab’s full chemistry analyzer.


In recent years, many research breakthroughs have used DNA and proteins to diagnose disease. Now useful discoveries involving RNA are poised to join the molecular diagnostic menu. Two microRNA (miRNA) molecules have been linked to a dangerous form of B-cell chronic lymphocytic leukemia (B-CLL), considered to be the most common human form of leukemia. Researchers at Ohio State University (OSU) in Columbus, Ohio published findings in Cancer Research that demonstrate a direct inverse association between expression of miR-29 and miR-181 and that of the TCL1 oncogene. “It works both directions,” stated Yuri Pekarsky, Ph.D., Associate Professor in the Department of Molecular Virology, Immunology, and Medical Genetics at OSU’s Comprehensive Cancer Center.


“High expression of these miRNA’s correlates with low expression of TCL1,” continued Pekarsky, “an indolent form of the cancer that is less likely to progress. A low level of miR-29 and miR-181 associates with a much more aggressive cancer.” The research team must now determine if these MicroRNAs work at the transcriptional or translational level, so it will be some time before these markers can be used in a diagnostic assay.


Quest Diagnostics Incorporated has entered the market for predictive genetic breast cancer tests. Announced last Thursday, the Breast Cancer Gene Expression Ratio is designed to “to help physicians predict the risk of disease recurrence in women with estrogen receptor (ER)-positive, lymph node-negative breast cancer.” Quest licensed technology from AviaraDx Inc. to use in this test.
Genomic Health Inc. recently announced a contract with Aetna, Inc. for its Oncotype DX assay, which predicts the likelihood of disease recurrence for breast cancer patients.


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