Abnova Corporation announced today that it has been granted an exclusive license of actinin-4 (ACTN4) biomarker from National Cancer Center Research Institute, Japan for the development and commercialization of
in vitro diagnostic (IVD) for stage 1 lung cancer. Due to early detection and prevention programs, majority of the lung cancer patients are being diagnosed with stage 1 disease. Despite early stage diagnosis, a substantial number of lung cancers relapse after surgery. Currently, there is no standardized treatment of adjuvant therapy after surgery for stage 1 lung cancer patients. The goal of ACTN4 biomarker is to distinguish stage 1 lung adenocarcinoma patients with favorable five year survival after surgery versus those which have a higher risk of recurrence thus requiring adjuvant therapy. The ACTN4 diagnostic test requires a combination of antibody immunohistochemistry (IHC) for qualitative assessment of protein expression and fluorescent
in vitro hybridization (FISH) test for quantitative measurement of gene amplification. This combination test is analogous to the Her-2/neu IHC and FISH testing for breast cancer in the commercial setting. Abnova’s ACTN4 IVD development starts with ISO13845 certification along with North America and Asia Pacific clinical studies followed by first regulatory submission this year.
Dr. Kazufumi Honda and Dr. Tesshi Yamada at the Japan National Cancer Center first discovered the role of ACTN4 as a novel actin-bundling protein associated with cell motility and cancer invasion. As a candidate oncogene, it has been extensively studied and implicated in a number of cancers including breast, colorectal, ovarian, and lung by the Japanese group and researchers worldwide. Most recently, Dr. Honda and Dr. Yamada have examined and validated the role of ACTN4 as a diagnostic biomarker of stage 1 adenocarcinoma of the lung in a retrospective analysis of multiple cohorts totaling >1700 patients who underwent resection of the lung adenocarcinoma. Their finding demonstrated that protein expression and gene amplification of ACTN4 significantly distinguish stage 1 lung adenocarcinoma with an extremely high risk of recurrence. Hence, patients with IHC and FISH positivity for ACTN4 ought to be followed closely and may receive benefits from adjuvant chemotherapy such as platinum-based drug. The efficacy of platinum-based postsurgical adjuvant for patients with advanced lung cancer has been well reported in a number of clinical trials.
The worldwide IVD market is estimated at $44.4 billion in 2009 and is expected to grow to $58.6 billion by 2014. Histology test, which is microscopic examination of cells and tissues, is one of the fastest growing sectors in the IVD industry, principally driven by innovations in cancer diagnosis. This is attributed to the introduction of new biomarkers, epitope-specific antibody for immunohistochemistry, and increased sophistication using fluorescent in situ hybridization technique. Lung cancer affects over 1.4 million patients. Non-small cell lung cancer, which accounts for approximately 87% of all lung cancers, is one of the leading causes of death, killing more patients than breast, colon and prostate cancer together and accounting for nearly 30% of all cancer deaths. Survival rates are among the worst for any cancer with a large and growing unmet clinical need.
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About Abnova
Abnova is a biotech company specializing in high throughput protein expression and antibody production. The manufacturing infrastructure Abnova has developed is a unique combination of world-class technologies and management experience of the IT industry in Taiwan. The company has vastly expanded the scope and availability of bio-tool reagents by taking a genome-wide approach to the production of human recombinant protein and antibody. In addition, it has developed a portfolio of system applications including antibody pairs, ELISA kits and assays, fluorescence in situ hybridization probes, label-free protein quantification and point-of-care,
in vitro diagnostic instruments which are essential to the translational research, diagnostic and pharmaceutical industries.(
www.abnova.com)
