Prenatal Testing Today
There is no accurate method for non-invasive prenatal testing. The "integrated screening" test is the most accurate alternative available today. This test combines a first trimester ultrasound (nuchal translucency), with serum tests performed during the first and second trimesters. This combined screening test has a 95% accuracy rate with a 5% false positive rate, with results received only during the second trimester, eliminating early pregnancy abortion techniques. Non-invasive first trimester screening tests have an accuracy rate of 85% with a 5% false positive rate. Both these tests screen only for a few syndromes and chromosomal abnormalities.
Alternative screening tests are amniocentesis and CVS, which provide accurate analysis of the fetus. These procedures are invasive, expensive, and are each with a significant risk to the fetus (0.5% risk of miscarriage for amniocentesis and 1.5% for CVS). Amniocentesis is done at a late stage in the pregnancy, eliminating the option of a first trimester abortion.
In order to facilitate non-invasive, accurate prenatal testing fetal nucleated red blood cells must be effectively separated from the maternal blood stream. BioCep is developing this non-invasive blood test, which will allow prenatal screening in the early stages of pregnancy.
The CEP Advantage
The Cell Enrichment Process will enable the isolation of fetus cells from maternal peripheral blood, during the first trimester of pregnancy, transforming the prenatal screening world as it exists today. BioCep's non-invasive screening will produce results equivalent to those of amniocentesis. Once developed this test will completely replace both amniocentesis and chorionic villus sampling as well as eliminate the need for the quadruple marker test, nuchal translucency or the integrated screening test. This simple blood test will not harm the fetus in any way and can be performed early in the pregnancy, to allow an abortion if necessary.
Market Opportunity
With over 10 million annual pregnancies in the US, EU, Canada, Australia and Japan, BioCep's non-invasive screening test presents a huge market opportunity. Today 2.5 million triple marker tests are performed annually in the US alone. Amniocentesis is recommended for all pregnancies when the mother is 35+ years old. This represents a steadily growing market, encompassing 14% of all pregnancies in the US. The non-invasive prenatal screening market represents a $1.5 billion annual market opportunity for BioCep.
