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The fertility crisis.

In the U.S., the total fertility rate has dropped to 1.72 – that’s the number of births each woman is expected to have in her childbearing years. It is now well below the replacement rate of 2.1 births required to renew populations.
The global picture is equally dire. In Europe, no country’s fertility rate exceeds 2.0: Germany’s is 1.5; the UK’s is 1.88; France’s is 1.852; and Italy’s is 1.33. In Australia, the rate is 1.74 – the lowest on record. Canada: 1.60. Brazil: 1.73. Japan: 1.44. South Korea: .98. All well below the replacement rate.

Ongoing declines in fertility rates will shrink populations and create grim economic consequences. Without enough new babies, populations will tip further toward older generations whose members will grow needier and less productive with age.

The Status Quo Has Achieved Only Limited Success.

First among assisted reproductive technologies is in vitro fertilization (IVF); the Mayo Clinic calls it the most effective treatment. But it presents hurdles:

Cost is a Major Issue.

Excluding medication and special testing, an IVF cycle ranges from $10,000 to $15,000. Since typical patients require more than two cycles, costs can easily come to $40,000 to $60,000. And just 10% of U.S. women are covered by insurance, says the Conference of State Legislatures.

And There Are Medical Issues.

If more than one embryo is transferred to the uterus (to boost the odds of successful implantation), IVF can result in unwanted, often risky multiple births. More, IVF that employs unreliable means of evaluating embryo viability increases the risk of premature delivery and low birth weight.

And what of Preimplantation Genetic Testing or morphological evaluation? The former, by which cells are extracted from an embryo and sent for genetic testing, is invasive, expensive, and doesn’t improve pregnancy outcomes. And the latter, the visual assessment of embryo quality using light microscopy, is insufficient to reliably evaluate the likelihood of a successful single-embryo transfer

The Market is Large and it’s Potential Even Larger.

The U.S. infertility-services market generated revenue of $5.87 billion in 2018, 71% of which came from IVF procedures. Although growth is estimated at 7% annually through 2023, the market can sustain far more vigorous growth. How do we know? It’s simple arithmetic:
With 75% of the market opting against treatment year after year (just 1% of affected women use IVF), a vast pool of prospective patients remains untapped.

It’s a large market. At Radiance, our opportunity to carve out a segment starts with this reality: Despite widespread adoption of morpho kinetics and invasive genetic testing, pregnancy rates from assisted reproduction have not improved. We exist to reverse this reality. How? By strengthening the reliability of noninvasive viable-embryo identification, we can help make in vitro fertilization more effective, less costly, less stressful, and thus more accessible to the 99% of women who now choose a different path or no path at all.

And Radiance Plays A Unique Role.

“[Because] the benefits of single-embryo transfer to the mother and child are well established… there has been a renewed focus on the requirement for reliable means of assessing embryo viability.”

David K. Gardner, Basak Balaban, Molecular Human Reproduction, October 2016

In the arena of in vitro fertilization, a successful single-embryo transfer is a home run. To hit them consistently, providers need a reliable means of identifying embryo viability; i.e., suitability for implantation. And if these means are noninvasive, so much the better.

Radiance delivers “so much the better.” Our mission: to create proprietary markers for embryo viability and thus promote single-embryo transfer and healthy birth. Our solution: A Research Use Only (RUO) ELISA test to determine the level of soluble human leukocyte antigen G (sHLA-G) in each fertilized embryo. Why sHLA-G? Because studies show that higher levels of sHLA-G indicate a greater likelihood of a successful pregnancy. And because our test uses samples of discarded media in which the embryos were previously grown, it is noninvasive and presents no risk to the patient or the embryo.