Sequencing and Analysis of the Hydra Genome
Chapman, Kirkness et al., Nature
An international research collaboration reports their sequencing and analysis of the Hydra magnipapillata genome, and compare it to the genomes of several other organisms. "The Hydra genome has been shaped by bursts of transposable element expansion, horizontal gene transfer, trans-splicing, and simplification of gene structure and gene content that parallel simplification of the Hydra life cycle," the authors write. They team suggests that comparisons of the Hydra genome to the reported sequences of other animals have helped them to elucidate the evolution of several of the organism's characteristics.
Abbott Labs Expects to Debut Epithelial Ovarian Cancer IVD Before End of Year
February 08, 2010
Abbott Labs before the end of the year plans to debut its Architect HE4 assay, which is designed to help oncologists monitor patients with epithelial ovarian cancer, the most common form of the disease.
Abbott today announced it had submitted the immunoassay for regulatory approval with FDA. The company is betting the blood-based assay will be indicated to help docs "monitor for the recurrence or progression" of epithelial ovarian cancer.
The test, currently an investigational device in the US, is expected to be "the first automated HE4 test available in US," according to Abbott. However, at least one other company, Quest, currently offers an FDA-cleared HE4 biomarker assay indicated to help physicians monitor for recurrence and of epithelial ovarian cancer.
An Abbott spokesperson today told me the company expects the test to win FDA clearance before the end of the year.
The HE4 biomarker is known to exist at "high levels in the blood of some ovarian cancer patients" and is believed to offer what Abbott calls "the highest sensitivity and specificity of any other marker" for the disease. It is also considered to be one of the best single markers for stage 1 of the disease. Less than 20 percent of all ovarian cancers are found in the early stage, according to the American Cancer Society.
According to Abbott, because certain types of ovarian cancers "rarely express HE4," the Architect HE4 "should not be used as a cancer screening test." Rather is designed "to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer, and must be used in conjunction with other clinical data."
According to Quest, CA 125 is "currently the serum marker most widely used to monitor therapeutic response and to detect disease recurrence in patients treated for epithelial ovarian cancer." The National Comprehensive Cancer Network "recommends CA 125 measurement before each treatment cycle for women with elevated pretreatment levels," and recommends CA 125 measurement at each follow-up evaluation if the level was initially elevated."
However, CA 125 "is not elevated in all patients with epithelial ovarian cancer; thus, other markers have been sought." One such marker is HE4, which has been shown in studies to have "comparable sensitivity to CA 125 … in postmenopausal women with ovarian cancer."
Other studies have found that HE4 and CA 125 "may be complementary," and some companies have already jumped at that finding. Last summer, Abbott said it has partnered with Fujirebio Diagnostics to co-develop a test for the "early detection of ovarian cancer that gauges levels of the protein serum CA125 and the human epididymal protein 4, or HE4."
Abbott's Architect HE4 assay, which was co-developed with Fujirebio, is already available in Europe, in some Asia-Pacific markets, and Latin America. Separately, Fujirebio last year penned a deal with Becton Dickinson to develop a molecular test based on the HE4 biomarker.
