Diagnostic Kit to Improve the Success of Assisted Reproduction

Temple University
posted on 08/05/2011

• request more info 
•   
•  LICENSE ONLINE

Background

Globally, there are greater than 4 million babies born per year; over 250,000 of these are from assisted reproduction. In the US, the number of ART (Assisted Reproduction Technology) cycles has increased from approximately 83,000 in 1999 to 148,055. 88% of these cycles use the mother’s own eggs while the rest may use donor eggs as their age increases. In 2008, ART resulted in 46,326 deliveries and 61,426 births which comprised 1.446% of births in the US. 50% of these transferred two embryos and 25% transferred 3 embryos. 25% of cycles resulted in birth and 25.7% of births were either multiple gestation births, high probability pre-term, and/or low birth weight. The average cost per cycle is $12,400 but multiple cycles are commonly needed as 62% result in no pregnancy. The total cost of the market therefore is approximately $1.84 billion (148,055 cycles in the US at $12,400 per cycle).

Summary

A method for evaluating the quality of a mammalian oocyte comprises: (a) determining the level of expression of at least one marker gene of a set of maker genes in a test sample derived from a cumulus cell or granulose cell associated with the oocyte, after maturation of the oocyte; and (b) comparing the expression level of said at least one marker gene expression in the sample with the expression level in a control, wherein detecting differential expression of the marker gene between the sample and the control is indicative of the quality of the oocyte.

Market Potential

• In 2010, the IVD services industry reached $44 Billion in the US alone.¹
• In 2009, the global women’s infertility market was valued at $1.42 billion and is forecasted to grow at a Compound Annual Growth Rate of 2%, reaching $1.61 billion by 2017.²
• The IVD market is expected to grow from $2.9 billion in 2009 to $7.2-$7.5 billion in 2014 at a Compound Annual Growth Rate of ~19%.³
• More and more clinics are lowering their prices from ~$15,000 to ~$7,500 for IVF treatments in order to help couples in different income brackets. This has allowed for increased growth in the market.⁴
• According to a recent survey on in vitro fertilization, some 250,000 test tube babies are born each year and many patients go for 2nd and 3rd attempts.⁵
• Assays could be delivered at modest cost to patient, at roughly 10-15% of current average cost/cycle, with potential for significant gains in success rates and reduction in risk

1. http://www.onemedplace.com/blog/archi...
2. http://www.pharmaceutical-market-rese...
3. http://www.marketsandmarkets.com/Mark...
4. http://www.newsweek.com/2010/07/20/sh...
5. http://www.geneticsandsociety.org/art...

Diagnostic kit for use in:
o Human infertility clinics
o Pig, goat, horse, or any species to which assisted reproduction is to be applied

• Molecular markers for diagnosing oocyte quality using a non-invasive approach could vastly improve success of assisted reproduction, both in the human clinic, and in agricultural applications.
• Screening and selection of high quality oocytes
• Provides a means of optimizing reproductive biology approaches to enhanced production of valuable agricultural species or enhanced species conservation approaches.