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BTG Strengthens Non-Invasive Prenatal Diagnostic Technology Patent Portfolio; Novel cell differentiation technique brings prenatal testing from maternal blood closer to reality.

Business Editors/Health/Medical Writers

WEST CONSHOHOCKEN, Pa.--(BUSINESS WIRE)--May 17, 2004

BTG (LSE: BGC), the intellectual property and technology commercialization company, announced today that it has strengthened its non-invasive prenatal diagnosis patent portfolio through the acquisition of a novel cellular fetal DNA diagnostic. The technology, developed by Professor Maj Hulten, has the ability to identify fetal DNA from the mixed cell population in the maternal bloodstream. This will allow fetal chromosomes to be investigated for several chromosome disorders, including Trisomy 21 (underlying cause of Down syndrome) from a maternal blood sample, without contamination by maternal chromosomes.

This novel technique, the Telomere Depletion Assay (TDA), is based on the difference in telomere length between fetal and adult cells where fetal chromosomes are known to have longer repeats of the telomeric DNA sequence. By discriminating between maternal and fetal cells, TDA takes non-invasive prenatal diagnosis to a new level of reliability, thereby increasing the functionality of BTG's existing non-invasive prenatal diagnostic, developed by Lo and Wainscoat while at the University of Oxford. One advantage of the TDA technology is that it is a pan-cellular approach and is not restricted to the identification of certain cell types. In addition to the cellular aspect of the technology, there appears to be the possibility of identifying fetal free DNA in maternal blood, as well as its development as a forensic tool.

According to the Centers for Disease Control and the American College of Obstetrics and Gynecology, each year in the US about 5 percent of the 4 million pregnancies are subject to invasive procedures (amniocentesis and chorionic villus sampling), resulting in 0.5 percent miscarriages. Among live born children, 1 in 200 carries a chromosomal abnormality and with the social trend in childbirth being that women are waiting longer to have children, concomitant risks in fetal genetic defects are more likely. Therefore, there is a growing need for a reliable non-invasive monitoring technique to determine chromosomal structure and integrity in pre-term fetuses."

Larissa Milne, from BTG's BioPharmaceuticals Business Unit said, "TDA represents an important advancement in the area of non-invasive prenatal diagnostics. The reliable, routine differentiation of fetal cells from maternal cells and/or DNA has been a longstanding challenge in this field, and has prevented development of a non-invasive assay with true clinical utility. The use of TDA could give companies operating in this area a significant edge in product development."

BTG is seeking to commercialize TDA through out-licensing, along with the intellectual property from Lo and Wainscoat. The cellular application of TDA, coupled with detection technologies such as fluorescent in-situ hybridization (FISH), is being exemplified in Professor Hulten's laboratory. Further development of the DNA component is underway to enable TDA's utility in DNA sequencing applications, such as PCR.

About BTG

BTG is an intellectual property and technology commercialization company that operates internationally. BTG creates value by investing in intellectual property and technology development, and in early stage ventures. We realize value through technology licensing, patent assertion and disposal of equity investments. Through a multidisciplinary approach, we apply intellectual property and commercial expertise, together with specialist skills in science and technology, to create major product opportunities in the health and high tech sectors. BTG has commercialized important innovations, including Magnetic Resonance Imaging, Multilevel Cell memory, and Factor IX blood clotting protein, the first recombinant treatment for Hemophilia B. BTG operates through wholly owned subsidiaries BTG International Ltd. and BTG International Inc. in the UK and USA, respectively. Further information on BTG can be found at www.btgplc.com

About Professor Maj Hulten

Professor Maj Hulten is currently the co-coordinator of SAFE, a Framework VI Grant from the EU. This grant, totaling EUR 12 million, has been allocated for a Network of Excellence to take non-invasive prenatal diagnosis further during the next five years. This network consists of 55 partners from 52 institutions including universities, hospitals and companies. Professor Hulten has spent over 30 years overseeing laboratories in the medical genetics field, including work with the National Health Service (UK) and is currently based at the University of Warwick.
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Publication:Business Wire
Date:May 17, 2004
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