Advancing women's reproductive diagnostics through noninvasive technology

Powered by our platform of noninvasive liquid biopsy, we are creating safe diagnostic and screening solutions that provide proactive insights into women’s reproductive health. These tools are centered around the prediction and early detection of complex maternal and gynecological health conditions, providing key health insights that can enable individualized care and better health outcomes for women.

Noninvasive Prenatal Screening

There is a growing need for accessible and low-risk prenatal screening as a proactive measure to assess the health of the pregnancy and discover signs of pregnancy-related complications. Expectant mothers should be empowered with the knowledge to make informed decisions about concerns that may impact their health and the health of their baby.

Historically, amniocentesis and chorionic villus sampling (CVS) have been used for prenatal testing in high-risk pregnancies to detect genetic conditions and abnormalities, but these invasive procedures come with their own risks and should only be administered when necessary for confirmatory purposes.

nps_1

50%

of spontaneous miscarriages involve fetal chromosomal abnormalities1

20%

of infant deaths are directly related to birth defects2

10%

of clinical pregnancies have chromosome abnormalities3

Our Approach

Noninvasive Prenatal Screening (NIPS) offers an early method of detecting the risk of a baby being born with a specific genetic condition. Using maternal plasma, we look for DNA methylation biomarkers to evaluate the fetal genetic health at a low risk to both the mother and baby.

Noninvasive prenatal screening is recommended for all pregnancies, regardless of maternal age or chromosomal risk.⁴ By screening for chromosome conditions early on in the pregnancy, expectant mothers can collaborate with their care team to determine the need for additional diagnostics testing.

Preeclampsia

Preeclampsia is a highly variable and complex medical condition related to pregnancy that is mainly characterized by the onset of high blood pressure and high levels of protein in the urine. There are several factors that can influence a mother’s risk of developing preeclampsia, however, the exact cause of the condition remains unknown. Preeclampsia can develop from as early as 20 weeks gestation and can even occur after delivery. The symptoms range from mild to severe, and can lead to further serious medical complications, such as preterm birth5 , making it one of the leading causes of maternal morbidity.

Preeclampsia_organ health-renal

2-10%

of pregnancies are affected by preclampsia6

12%

of global maternal deaths are directlt related to preeclampsia7

500,000

global fetal deaths occur every year due to preeclampsia8

Our Approach

We are developing noninvasive technology for the early gestational screening of preeclampsia by analyzing cfDNA methylation patterns in maternal plasma. While there is currently no known cure for preeclampsia, early detection and appropriate management of symptoms can help improve the likelihood of a safe birth and reduce the mother’s risk of developing other potentially life-threatening complications.

Preterm birth

Preterm birth—any birth that occurs before 37 weeks gestation—is associated with high risks of morbidity and mortality, making it a major health concern in obstetrics. Infants who survive preterm birth are often at a higher risk for chronic diseases and conditions.

preterm_birth_1

12%

of U.S. births are preterm9

1M

Every year, 1 million preterm infants die worldwide due to complications from preterm birth10

20%

Over 21.5% of preterm infants are born with birth defects11

Our Approach

The prediction of spontaneous preterm birth could allow for revised birth plans and other healthcare adjustments to improve the likelihood of a healthy birth. Rather than obtaining amniotic fluid or fetal blood, we are developing a solution using a maternal blood sample as a low-risk and minimally invasive method to identify DNA methylation biomarkers. These biomarkers may help predict the risk of pregnancy complications associated with preterm birth.

Endometriosis

Endometriosis is a chronic gynecological condition characterized by the presence of endometrial tissue outside its normal anatomic location. There is currently no known cure for the condition, often causing many debilitating symptoms and a severe impact on a woman’s quality of life. Women with endometriosis have a high risk of infertility as well as developing endometriosis-associated ovarian cancer.

endometriosis_1

15%

of reproductive age women are impacted by endometriosis12

4-11 Years

the average waiting period between the onset of endometriosis symptoms and diagnosis13

30%-50%

of women with endometriosis experience infertility14

Our Approach

Traditional diagnostics of endometriosis typically involve a laparoscopy—an invasive surgery that is often not a timely or accessible option for many patients. Our approach utilizes patient plasma as a minimally invasive method to identify DNA methylation biomarkers for early detection of endometriosis.

References

  • 1 Hassold, T., Chen, N., Funkhouser, J., Jooss, T., Manuel, B., Matsuura, J., Matsuyama, A., Wilson, C., Yamane, J. A., & Jacobs, P. A. (1980). A cytogenetic study of 1000 spontaneous abortions. Annals of Human Genetics, 44(2), 151-164. https://doi.org/10.1111/j.1469-1809.1980.tb00955.x
  • 2 Matthews T.J., MacDorman M.F., Thoma M.E. (2015). Infant mortality statistics from the 2013 period linked birth/infant death data set. National vital statistics reports; 64(9), Hyattsville, MD: National Center for Health Statistics.
  • 3 Nagaoka, S. I., Hassold, T. J., & Hunt, P. A. (2012). Human aneuploidy: Mechanisms and new insights into an age-old problem. Nature Reviews. Genetics, 13(7), 493-504. https://doi.org/10.1038/nrg3245
  • 4 Rose, N. C., Kaimal, A. J., Dugoff, L., Norton, M. E., American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins—Obstetrics, Society for Maternal-Fetal Medicine, & Committee on Genetics. (2020). Screening for fetal chromosomal abnormalities: ACOG practice bulletin, number 226. Obstetrics and Gynecology (New York. 1953), 136(4), e48-e69. https://doi.org/10.1097/AOG.0000000000004084
  • 5 Davies, E. L., Bell, J. S., & Bhattacharya, S. (2016). Preeclampsia and preterm delivery: A population-based case-control study. Hypertension in pregnancy, 35(4), 510–519. https://doi.org/10.1080/10641955.2016.1190846
  • 6 Osungbade, K. O., & Ige, O. K. (2011). Public health perspectives of preeclampsia in developing countries: implication for health system strengthening. Journal of pregnancy, 2011, 481095. https://doi.org/10.1155/2011/481095
  • 7 Nour, N. M. (2008). An introduction to maternal mortality. Reviews in obstetrics & gynecology, 1(2), 77–81.
  • 8 Dawson, E. L., Khoury, M. J. (2022). Preeclampsia, genomics, and public health. Centers for Disease Control and Prevention.
  • 9 Witt, W. P., Cheng, E. R., Wisk, L. E., Litzelman, K., Chatterjee, D., Mandell, K., & Wakeel, F. (2014). Preterm birth in the united states: The impact of stressful life events prior to conception and maternal age. American Journal of Public Health (1971), 104(2), 73.
  • 10 Blencowe, H., Cousens, S., Chou, D., Oestergaard, M., Say, L., Moller, A., Kinney, M., Lawn, J., Born Too Soon Preterm Birth Action, Born Too Soon Preterm Birth Action Group, & the Born Too Soon Preterm Birth Action Group (see acknowledgement for full list). (2013). Born too soon: The global epidemiology of 15 million preterm births. Reproductive Health, 10(1), S2-S2. https://doi.org/10.1186/1742-4755-10-S1-S2
  • 11 Behrman, R. E., Butler, A. S., & Institute of Medicine (US) Committee on Understanding Premature Birth and Assuring Healthy Outcomes (Eds.). (2007). Preterm Birth: Causes, Consequences, and Prevention. National Academies Press (US).
  • 12 McLeod, B. S., & Retzloff, M. G. (2010). Epidemiology of endometriosis:: An assessment of risk factors. Clinical Obstetrics and Gynecology, 53(2), 389-396. https://doi.org/10.1097/GRF.0b013e3181db7bde
  • 13 Yale Medicine. (n.d.). Endometriosis. Link
  • 14 Bulletti, C., Coccia, M. E., Battistoni, S., & Borini, A. (2010). Endometriosis and infertility. Journal of assisted reproduction and genetics, 27(8), 441–447. https://doi.org/10.1007/s10815-010-9436-1