| RareCellect™ |
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RareCellect™: safe, sensitive and reliable pre-natal testing Genetic Technologies is advancing a pre-natal testing platform that is poised to make significant advances in the identification of genetic disorders prior to birth. As part of this project, the Company has designed and tested a proprietary sampling device that can safely and reliably collect fetal material from the cervix, and has combined this with a proprietary processing technology that selectively delivers either cellular material or DNA from the fetus which is suitable for analysis to identify genetic disorders using currently available diagnostic technologies. Background and unmet need Genetic disorders account for a significant health burden across the world, with over 330,000 children born with congenital malformations annually in the US, Europe and Japan. In addition, between 20% and 30% of post-natal deaths are due to such congenital malformations. In the developed world, it is increasingly common for women to have babies later in life (25% of these births are born to women over 35 years of age), and this can significantly increase the risk of genetic disorders in their offspring. Current pre-natal testing involves non-invasive screening and invasive diagnostic testing. Screening uses ultrasound of the fetus and maternal serum testing and can be performed from 11 to 13 weeks of pregnancy. Although safe, these tests are not reliable, with a detection rate of 80% (20% of abnormalities are not detected), and a false positive rate of 5% (women with healthy babies being subjected to unnecessary invasive testing). Diagnostic testing requires the removal of fetal material using chorionic villus sampling (from 11 to 14 weeks) or amniocentesis (from 15 to 20 weeks). Each of these surgical procedures involves the insertion of a needle into the uterus to obtain cellular material from the fetus which can then be tested for abnormalities using a variety of tests. Although accurate, these tests are invasive and carry a significant risk to both the fetus and the mother. Miscarriage rates, which can be as high as 5%, are dependent on the skill of the operator and the gestation age. Furthermore, testing is limited to high-risk patients including women over the age of 35 and results may take as long as two weeks to obtain. GTG believes that there is a clear unmet need in pre-natal testing for risk-free (for both mother and fetus) chromosomal/genetic testing for the fetus at as early as eight weeks gestation. The RareCellect™ solution GTG has developed a proprietary sampling device using materials and design features which will ensure safe, non-traumatic sampling of the optimal region of the cervix to yield fetal cellular material. The current design, which has been used by a number of healthcare professionals to sample fetal material from more than 400 women, is protected by a US provisional patent. The Company has also identified issues relating to the processing of fetal material that limit its utility for subsequent testing, including contamination from maternal cells, sperm cells and other DNA. Genetic Technologies has developed processing methods, which are also covered by provisional patents, that can deliver fetal cells or DNA in a form suitable for testing using any of the currently approved diagnostic methodologies. Commercial opportunity The Company believes that RareCellect™ offers a unique opportunity to successfully penetrate the $2 billion global pre-natal testing market, with the potential for market launch within three to five years. By offering a safe sampling and processing methodology that provides sufficient fetal material for subsequent analysis, it has the potential to displace currently available maternal screening tests and to avoid the need for most of the current invasive diagnostic procedures. |
