Abnova and MBL Japan Join Forces on ACTN4 In Vitro Diagnostic of Lung Cancer
Neihu, Taiwan (August 23, 2013)
Abnova and MBL Japan announced an exclusive license for development and commercialization of ACTN4 in vitro diagnostic (IVD) of lung cancer. Under the collaboration, Abnova is responsible for GMP manufacturing of ACTN4 monoclonal antibody and FISH probe, and MBL is responsible for a larger scale clinical trial, regulatory clearance, sales, and distribution of ACTN4 IVD in Japan. An initial study of >1,700 Japanese patients has established ACTN4 is a significant predictive biomarker of stage 1 non-small cell lung adenocarcinoma for patients with favorable five year survival versus those having a high risk of recurrence after surgery (published in Annals of Oncology July 30, 2013 and Japan ASAHI Shinbun News August 17, 2013).
ACTN4 diagnostic test requires a combination of monoclonal antibody immunohistochemistry (IHC) for expeditious, qualitative screening of protein expression, followed by fluorescent in situ hybridization (FISH) test for quantitative validation of gene amplification on surgically resected tissue. Such combination of monoclonal antibody and FISH probe has become a powerful tool for cancer diagnosis prior to therapy. Abnova has also identified a large global diagnostic company for collaboration in the US and Europe while spearheading its own ACTN4 clinical trial in China.
“Despite early stage diagnosis, approximately 50% of surgically resected lung cancer patients will relapse and die of recurrent disease within 5 years. Currently, there is no standardized management of adjuvant therapy after surgery for stage 1 lung cancer patients,” said Dr. Wilber Huang, President and CEO of Abnova. Patients with both 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.”
Lung cancer is a leading cause of malignancy-related death worldwide, affecting 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. Recent broader use of low dose spiral CT scan is identifying more lung cancer with smaller size at an earlier stage.
----------------------------------------------------------------------------------------------------------------------------------------------------------------
About Abnova
Abnova has established a comprehensive portfolio of fully integrated solutions and services to address the needs of the in vitro diagnostic industry. Abnova provides its customers access to the new rabbit monoclonal antibody, ELISA kit, FISH probe, protein quantification and circulating rare cell system solutions. Abnova’s facility is ISO13485 and GMP certified for immunohistochemistry, ELISA kit, and FISH probes.
|
