Abnova Provides GMP Bioreagent and System Solution for Non-Invasive Prenatal Diagnosis Market
Neihu, Taiwan (July 3, 2013)
Abnova Corporation officially announced today that it has entered into the non-invasive prenatal diagnosis market. Leveraging its expertise in monoclonal antibody and FISH probe design and manufacturing under ISO13485 and GMP standards, Abnova develops and provides the key bio-tools for capturing and identifying fetal nucleated red blood cells (fNRBC). Isolation of fNRBC from maternal peripheral blood has been a major goal for non-invasive prenatal diagnosis. Up until now, engineering difficulty and ineffective bioreagent and system integration have resulted in inconsistent fetal cell capturing and purity, thus hampering its long-sought prenatal application and deployment in the commercial setting. As a first step, Abnova will be commercializing the bioreagent and system into the reference laboratory markets. Abnova is also preparing an independent ISO15189 certified service laboratory adjoining its Neihu headquarter.
“We are in a vantage position and timing to contribute and capture this important prenatal diagnosis market,” said Dr. Wilber Huang, President & CEO of Abnova. “The landscape for prenatal diagnosis has undergone drastic changes recently. Array-based cytogenetic assay is replacing the traditional karyotyping, though both methods rely on more invasive amniocentesis performed after 16 week gestation. The newer serum-based, cell-free DNA analysis can be performed for higher risk pregnancies around 9 week gestation but genetic abnormalities still need to confirmed with a more invasive procedure. Isolation of fNRBC from material peripheral blood offers the advantage of non-invasive procedure, an even earlier prenatal testing around 7 week gestation, and most importantly, accessibility to the fetal cell nuclear genome for complete genetic analysis.”
“High quality bioreagents are a prerequisite for successful integration of advanced technologies and supporting electronics to achieve a market-driven, biomedical application,” said Dr. Hann Wen Guan, Vice President of R&D of Abnova and former Director of Optoelectronics at Industrial Technology Research Institute (ITRI). “We are also highly privileged working with Dr. Hsian-Rong Tseng, Professor of California NanoSystem Institute, University of California, Los Angeles (UCLA) who has pioneered the nano-velcro surface and herringbone microfluidic technologies for isolation of circulating rare cells such as fNRBC. There is a tremendous opportunity here to catapult a revolutionary, non-invasive prenatal diagnostic platform into the forefront of medical care.”
Abnova is hosting a Non-Invasive Prenatal Diagnosis Symposium in National Taiwan University on July 24, 2013 for presentation, discussion and product showcase. We are inviting the academia, clinical colleagues and interested participants to join this focused meeting.
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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.
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