LOS ALTOS, Calif., July 19 /PRNewswire/ --
Univfy, a pioneer in the development of personalized in vitro fertilization (IVF) prognostic tools, announced today the publication of new research findings in the journal Proceedings of the National Academy of Sciences (PNAS) by its founding scientific team and clinical collaborators from Stanford University.
The peer-reviewed paper details their development of the first rigorously validated prognostic test for predicting IVF live birth outcomes for patients who have failed their first IVF attempt. In their validation test, this novel prognostic algorithm showed a more than 1000-fold improved live birth outcome prediction when compared to the age-based prediction model that is commonly used today (p<0.05). Using this prediction model, the validation data showed that more than 60 percent of patients in the study received a significantly different, yet more accurate, prediction of live birth outcome in a subsequent IVF cycle as compared to conventional age-based prediction.
Stanford scientists, including Univfy's co-founders, developed the proprietary algorithm by examining 52 prognostic factors, such as body mass index, embryo development, and response to hormonal medications, along with analyzing the impact of those factors on IVF live birth success. The researchers extracted IVF outcomes data from more than 5000 IVF cycles performed at Stanford Hospital and Clinics from 2003-2008. 1676 treatments comprised the training data set that was used to generate the prediction model, which was subsequently validated in a separate set of 634 treatments that were performed in 2007-2008 in an unrelated group of patients.
Univfy has obtained the exclusive license from Stanford University to develop and market this technology (patent pending), and plans to offer test services to patients and physicians in the fall of 2010, subject to clearance for use by the U.S. Food and Drug Administration (FDA). These new prognostic tests would allow IVF physicians to provide live birth probabilities that are specific to each patient – and thus, are more meaningful – to best inform them as they navigate the difficult decisions that often come with IVF treatment.
"We believe that providing high quality, customized prognostics will empower patients with the information they need to make IVF decisions with greater confidence. We are excited about this merging of personalized medicine with reproductive medicine," stated Mylene W. M. Yao, M.D., president and co-founder of Univfy. "Since this model uses clinical data from a previously failed IVF attempt, a first IVF treatment can be viewed both as an infertility treatment and as a potential prognostic tool for future cycles. Most remarkably, Univfy's proprietary algorithms do not require any additional blood tests or medical procedures, but rather, utilize a patient's existing clinical data to provide a personalized and highly accurate probability of live birth."
Today, approximately 7.2 million couples in the U.S. and 60-80 million couples worldwide are affected by infertility. First successfully utilized in the late 1970s, IVF is the process of fertilizing an egg with sperm outside of the womb and culturing the resulting embryos in vitro, until they are transferred back to the womb three to five days later.
Since its inception, IVF has been credited with the birth of more than one million babies worldwide. The total number of IVF cycles attempted in the U.S. has increased by three to six percent each year, reaching approximately 140,000 IVF cycles in 2008, which represents a less than two percent utilization rate for IVF. This low usage rate might be explained by barriers such as high treatment costs, minimal or lack of insurance coverage in many states, emotional stress, and the lack of patient-specific outcome prediction.
The market for infertility treatment in the U.S. alone is estimated at more than $3B. The most significant segment of the infertility market is in vitro fertilization (IVF), which accounts for over $2B.
Univfy was founded in November 2009 by Stanford University professors, Mylene Yao, M.D., and Wing Wong, Ph.D., who developed a novel approach to predicting live birth outcomes in in vitro fertilization (IVF). The company is committed to helping infertile patients build healthy families by delivering personalized prognostic tests that support physicians and empower patients during infertility treatment decision-making.
For more information about Univfy, please visit: www.univfy.com.
The academic research that is the basis for Univfy's platform was led by Stanford scientists M. Yao, M.D., Wing H. Wong, Ph.D., Prajna Banerjee, Ph.D., and Bokyung Choi, Ph.D. candidate, and clinical collaborators Drs. L. Westphal, R. Lathi, L. Shahine (currently at Pacific Northwest Fertility and IVF Specialists), K. O'Leary, and S. Jun (currently at Palo Alto Medical Foundation). The academic work was funded by the NIH, NICHD, and the Stanford-Coulter Translational Research award.