October 10, 2014, Shenzhen, China-- The European Patent Office has issued patent number EP2561103B1 for invention to BGI for its independently researched non-invasive prenatal genetic test (NIPT) technology. This technology has been developed by BGI in connection with the provision of its market leading NIPT, the NIFTY® test. The patent is effective in 15 member countries including England, Belgium, Spain, Slovenia, Hungary, Sweden, Turkey, Switzerland, Italy, France, Denmark, Germany, Czech Republic, Poland and Romania.
This patent was granted by the European Patent Office. This is the first patent for non-invasive prenatal genetic testing technology approved by the Europe Patent Office to a mainland Chinese registered company.
Meanwhile, the State Intellectual Property Office of China also issued a Notice of Grant of Patent Right to BGI, meaning that this patent has been granted domestically as well as internationally.
This global recognition for BGI's technology comes after BGI became the first non-invasive prenatal test provider to receive approval from government level for a second generation gene sequencing diagnostic product when it obtained approval from the CFDA in July, 2014.
As of August, 2014, BGI Dx, a subsidiary unit of BGI, has provided non-invasive prenatal genetic testing services via its NIFTY® test to nearly 400,000 pregnant women worldwide.
This patent relates to non-invasive testing technology of fetal genetic abnormality, that was researched and developed independently by BGI, through carrying out DNA sequencing in blood samples of pregnant women, to non-invasively detect for fetal genetic abnormality.
BGI's technology involves use of a core algorithm for determining GC content differences in chromosomes, improving accuracy of the result. This technology is used in the test screening for the three most common trisomy conditions present at birth (trisomy 21, 18 and 13) but also covers screening for sex chromosomal conditions XO, XXX, XXY, XYY and certain deletion syndromes, and is included as part of the NIFTY® offering at no additional charge.
As a leader in the non-invasive prenatal genetic testing industry, BGI Dx has always devoted itself to independent research and development as well as to innovation connected to broader genomics technology conversion applications. BGI Dx has published more than 30 academic articles related to non-invasive prenatal genetic testing and has 72 relevant patent applications spreading over a dozen countries in Asia, America and Europe. NIFTY® is offered in more than 2000 healthcare providers covering 52 countries including England, Australia, Spain, Singapore, Israel, Czech Republic, Turkey, Thailand and China. As of August 2014, nearly 400,000 test samples have been processed with accuracy rate for trisomies 21, 18 and 13 of more than 99.9%.
The multinational authorization for the patent of non-invasive prenatal genetic testing technology for NIFTY® indicates that non-invasive prenatal genetic testing has undergone a new breakthrough. BGI Dx is dedicated to continuing the development of new genetic testing technologies and expanding the non-invasive prenatal testing industry for the benefit of all.
About BGI Dx (BGI Diagnostics Co.)
Since its foundation, BGI Dx has always devoted itself to multidisciplinary genomics research with the aim of applying cutting edge discoveries to the field of medical testing in an economical, simple and effective manner. BGI Dx's mission is to improve the process of diagnosis and treatment options for life limiting birth defects and critical illnesses such as cancer and monogenic diseases.
BGI Dx has developed a series of test services based on multidisciplinary technologies and approaches, including independent core technologies such as high throughput sequencing, high sensitivity mass spectrum and big data analysis. BGI Dx's test product provision covers the entire human lifecycle from conception, pregnancy and birth, to old age.
About non-invasive prenatal genetic test （NIFTY®)
Through collecting a small sample of peripheral blood from the pregnant woman, NIFTY® is able to extract cell free fetal DNA. Utilizing next generation high throughput sequencing technology combined with bioinformatics analysis, NIFTY® provides a highly accurate risk rate of occurrence for chromosomal aneuploidy in the fetus.
As a non-invasive prenatal test, NIFTY® avoids the risk of miscarriage associated with invasive diagnostic procedures such as amniocentesis, which carries a 1% risk of miscarriage.
As of August 2014, non-invasive prenatal genetic tests provided by BGI Dx are offered by more than 2000 healthcare providers in more than 52 countries including England, Australia, Spain, Singapore, Israel, Czech Republic, Turkey, Thailand and China, with nearly 400,000 test samples processed so far, and with an accuracy rate of more than 99.9%. Non-invasive prenatal testing is particularly suitable for pregnant women who have certain indications including pregnant women who have received a high risk result from serological screening; pregnant women who have experienced habitual abortion; pregnant women with puncture contraindications; pregnant women not suitable for or unwilling to undergo invasive prenatal diagnosis such as amniocentesis and pregnant women of advanced maternal age.