In the News


Abnova Gained Japan PMDA Permission to Advances ACTN4 In Vitro Diagnostic (IVD) Biomarker for Lung Adenocarcinoma into Clinical Trial in Japan


2018/02/08


Abnova announced it has gained Japan PDMA permission to start ACTN4 predictive biomarker for lung adenocarcinoma clinical trial in Japan, based on Abnova’s newly prepared documents and supporting data provided to PMDA throughout last year. Abnova had to revise and provide additional clinical evidence to develop ACTN4 as predictive biomarker for Tegafur/Uracil, also called UFT (Uracil and 5-FU) adjuvant therapy for stage 1 non-small cell lung adenocarcinoma (NSCLC), instead of a previously planned, prognostic biomarker. Going forward, Dr. Kaoru Kubota of Nippon Medical School Hospital is the Principal Investigator of the ACTN4 clinical trial; Dr. Kazufumi Honda will be the technical advisor. Patient samples will be collected from Nippon Medical School Hospital, National Cancer Center, and Tokyo Medical University Hospital. The clinical trial will be finished before end of this year 2018 and pending PMDA approval by mid-year 2019. If approved, ACTN4 will be a monumental biomarker for traditional chemotherapies such as uracil and 5-FU, because such biomarker has been very difficult to come by and develop in the clinical setting.

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. An initial retrospective study of >1,700 Japanese patients has established ACTN4 is a significant 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. Despite early stage diagnosis, approximately 50% of surgically resected lung cancer patients will relapse and die of recurrent disease within 5 years.

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 to address the needs of the in vitro diagnostic (IVD) industry. Abnova provides its partners and customers access to the technologies, products and services relating circulating rare cell, circulating exosome, and circulating cell-free RNA for early to metastatic and recurrent disease and treatment diagnosis, guidance, prediction, and monitoring. Abnova facility is ISO13485 and GMP certified for bioreagent and automation development and manufacturing for clinical trials and IVD commercialization. (www.abnova.com)


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