Abnova Foray into the In Vitro Diagnostic Market
Neihu, Taiwan (December 14, 2010)
The movement toward personalized medicine has created an increased market demand for biomarkers which can detect early sign of disease, assess disease prognosis, predict treatment outcome, and manages disease activity. With a strong foothold in antibody manufacturing and antibody-based, system integration in profiling and quantification, Abnova has made a seamless transition and foray into the in vitro diagnostic (IVD) market. In order to maximize the success of an approved IVD product and minimize its risk in development and commercialization, Abnova has garnered a pipeline of IVD products which satisfies the unmet need in the growing personalized market. Abnova recapitulates the current status and progress of its IVD product development, patent application, clinical study, ISO certification, and roadmap for regulatory submission and approval.
From Antibody to Antibody System to In Vitro Diagnostics
Abnova first built a large repertoire of monoclonal antibodies for tissue immunohistochemical studies. Abnova then assembled a tissue microarray platform, ProteoScreen™, for high throughput antibody screening to identify biomarkers with statistical correlation to disease and treatment. For biomarker secreted into the serum, Abnova next produced capturing and detection antibody pair for protein quantification. For all IVD products, tissue and serum samples provide the most convenient access for analysis of protein biomarkers related to disease. These clinically relevant, protein biomarkers become the targets of immunohistochemical antibody and ELISA (enzyme-linked immunosorbent assay) kit detection and measurement. Most importantly, these antibodies and kit constitute the integral bio-tools of a developing IVD product. Their function and intended use supported by evidence-based, retrospective or prospective clinical studies become the specification of a submitted and eventually FDA approved IVD.
Completion of ISO13845 Certification for Tissue Biomarker
Utilizing ProteoScreen™ platform, Abnova and Japan National Cancer Center have discovered a novel tissue biomarker, which correlates with poor prognosis in ovarian cancer patients, and a jointly filed for a patent in September this year. This biomarker is a trans-sulphuration enzyme which cross path with cisplatin, a chemotherapeutic agent used in ovarian cancer. Inhibition of this biomarker has also been sought as a way to overcome cisplatin chemoresistance, a long-standing problem in ovarian cancer therapy. With completion of ISO13845 certification for immunohistochemical (IHC) antibody earlier this month, Abnova aims to file for FDA Class I approval by first quarter 2011 which will allow Abnova to initiate discussion with drug companies to explore development of small molecule drug targeting this biomarker and further development of IHC antibody into Class III PMA companion diagnostic. To date, there is no drug or diagnostic which specifically targets and detects cisplatin chemoresistance in ovarian cancer.
Initiation of Large Cohort Clinical Studies for Serum Biomarkers
In collaboration with Chang Gung Hospital, Abnova has developed the first generation of antibody pair for a novel STIP1 serum marker for early detection of ovarian cancer. However, the progress has been delayed by an unexpected interference from the ruptured red blood cell during ELISA assay development. This is due to the high similarity of ovarian cancer and red blood cell STIP1 protein. To overcome this hurdle, Abnova has re-manufactured a second generation antibody and antibody pair in the last six months. The validity of this biomarker will be confirmed by a prospective clinical study (>1000 patients) to be carried out at Chang Gung Hospital. The hospital has been granted a patent on STIP1 biomarker just recently. Abnova has submitted a patent covering the new monoclonal antibody and antibody pair. Abnova aims to complete the ISO13485 certification for ELISA kit by third quarter 2011. The validity and result of the large cohort study will serve the basis of FDA Class II submission.
By systematic screening of over 1500 antibodies, Abnova and Japan National Cancer Center have identified three novel serum biomarkers showing preferential expression in pancreatic cancer patients. Patent application has been jointly filed covering biomarker targets and their utility. As antibody pair construction is needed for serum protein quantification, this has been a most time consuming part of the diagnostic development. Nonetheless, Abnova and Japan National Cancer Center is scheduled to launch a retrospective clinical study (>400 patients) this month to validate the clinical significance of these biomarkers. The study will be completely by March 2011. Abnova aims to complete the ISO13485 certification for ELISA kit by third quarter 2011. The validity and result of the large cohort study will serve the basis of FDA Class II submission.
In addition to the development of human monoclonal antibody targeting HMGB1 for sepsis, Abnova has manufactured a set of antibody pair for quantitative measurement of HMGB1 in serum. As severity and prognosis of septic patients are principally related to HMGB1 level in their serum, HMGB1 measurement is a prerequisite for diagnosis, treatment, and monitoring of septic patients. The construction of the ELISA kit is in progress. By first quarter 2011, Abnova aims to identify hospital for the collaboration of clinical study to validate the utility of the HMGB1 kit. Abnova intends to complete the ISO13845 certification process by June 2011.
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 integrated and system applications including antibody pairs, ELISA kits, high content screening assays, and label-free protein quantification system which are essential to the biomarker discovery and translational research industries. (www.abova.com)