Advanced Prenatal Testing

Our products will provide women with a simple, non-invasive and accurate alternative to the invasive testing methods available today, such as amniocentesis and chorionic villus sampling (CVS). With a single, maternal blood draw early in pregnancy, our test will provide diagnostic information without risk to the mother or her fetus.

Pioneering work by Diana Bianchi, M.D., and colleagues has shown the significance of isolating fetal cells in maternal circulation to provide a complete genetic picture of the fetus, with the highest confidence of fetal origin. In addition, by gaining access to the entire fetal genome, we have the opportunity to test for any serious disability in the fetus, not simply the common aneuploidies.

We have developed a proprietary microfluidic technology that successfully and reliably recovers intact fetal cells from maternal blood samples. In the laboratory, our device gently separates these rare cells of interest from the billions of maternal background cells. The result is an unparalleled recovery of intact fetal cells that can provide critical clinical information.

In addition to our focus on recovering and analyzing intact fetal cells, we are developing cell-free DNA-based approaches in collaboration with Stephen Quake, Ph.D., to quantify fetal DNA fragments found in maternal circulation. This will allow us to develop a non-invasive prenatal diagnostic test solely for detection of fetal aneuploidy, the most common clinical concern for pregnant women and their physicians.

Working in collaboration with leading research and clinical institutions, we have clear knowledge and expertise in testing both intact fetal cells (to replace the current invasive diagnostic tests) and fetal cell-free DNA (to replace prenatal screening tests for aneuploidy). We believe our exclusive focus on diagnostic results in early pregnancy will transform the field of prenatal testing.

New clinical guidelines in prenatal testing

Our first product will be based on a simple, non-invasive approach for early prenatal detection of fetal chromosomal abnormalities. Recent guidelines in clinical care from the American College of Obstetrics and Gynecology (ACOG) recommend that all pregnant women should be offered prenatal screening for fetal abnormalities, with emphasis on early, non-invasive testing options. For most women, early testing provides reassurance that the pregnancy is developing normally.