The first test to restore fertility wellness based on cutting-edge technologies derived from microbiome research was launched, thanks to a collaboration between Microgenesis and renegade.bio. Furthermore, this new hope for fertility wellness is delivered at home.
Delivering the precise product that will be a game-changer for fertility wellness was the main concern of Microgenesis, a new startup empowered by the IndieBio accelerator program. Their product packages different scientific ideas to help women restore their fertility potential in the most natural possible way. To make the difference, they needed a partner that understands the challenges and has the expertise to work with cutting-edge technologies in a CLIA lab environment. As another IndieBio alum, renegade.bio was a natural choice since they had already collaborated with other companies such as CASPR to develop a COVID PCR testing methodology.
Microgenesis’ approach came from women scientists who understand women’s needs. They performed research in immunology and the microbiome to identify the connection between intestinal microbiome disbalance and the fertility potential. “After 15 years of research from basic science to clinical studies, we discovered that we can change the equation in a simpler way. Nature has taught us that if a woman has even the potential to develop a disease, it can prevent her from becoming pregnant. So we started to package all this expertise in a test that provides the information to restore fertility potential without using drugs and invasive treatments,” said Gaby Gutierrez, co-founder and CEO of Microgenesis
After finishing IndieBio’s accelerator program, Microgenesis teamed up with renegade.bio to launch an alpha test group of 40 women. “We are excited to help Microgenesis fulfill women’s dreams. As a CLIA-certified lab, we understand the need for rapid and reliable testing. Working with Microgenesis is awesome, because their work combines research from immunology, endocrinology, and microbiome, and they challenge us to measure a lot of parameters. They don’t go for the easy way—they actually work with a wide array of results to provide their recommendations” said Craig Rouskey, MSc, co-founder and CEO of renegade.bio.
The work involved to validate the qRT-PCR techniques that Microgenesis develops and understand the parameters involved in the Microgenesis’ test. “We are pioneering qRT-PCR testing using the SalivaDirect testing method, which involves delivering results to organizations, individuals, and communities. This enables us to team up fast to deliver tests for the Microgenesis alpha test group,” said Rouskey. As the first analyses evolve, Microgenesis has 370 more patients on its waiting list. “We expect a soft launch in late May,” said Gutierrez.
One out of five women of reproductive age feels the emotional pain caused by the inability to conceive. The fertility industry has come a long way in designing medical technologies and treatments to try to make the dream of motherhood come true. However, the most popular strategies focus on the baby and not on the woman’s body. The fertility industry revolves around one question: How to achieve pregnancy? As a result, women seeking to conceive have been bombarded with all kinds of hormones and overly complex treatments.
Microbiome is a new field in medicine that studies the bacterial, virus, and fungus populations that coexist symbiotically in the human body. Differences in these populations can lead to health issues, including infertility. Eighty percent of infertile women have inflammatory conditions tied to imbalances of the microbiome that can affect reproductive outcomes. In a recent clinical study of 287 patients with unsuccessful IVFs who were treated with Microgenesis, 75% became pregnant and 129 babies were born. In a follow-up study with pre-IVF patients, 92% are now pregnant. The impact of the microbiome on fertility from the immunology side is well explained in this video.
“Intestinal health has the potential for marked impact on fertility outcomes, but current generic approaches appear ineffective. Microgenesis’ analytic and corresponding nutraceuticals and probiotic supplementation are unique because they are actionable and specific to each patient. Initial results are significant, and I believe that this product can become an important adjunct to traditional strategies that I use today” said Dr. Steven Nakajima, M.D., Director of IVF at Stanford Lucile Packard Children’s Hospital and Clinical Professor at Stanford University.
Microgenesis’ test utilizes a proprietary non-invasive technology that identifies the unique microbiome and immune metabolic profile using a vaginal swab, saliva sample, and blood drop. The results of the test are used to prepare a highly personalized 90-day drug-free treatment regimen consisting of a 100% natural formulation of nutraceuticals, probiotics, and dietary recommendations. “Our final goal is to restore fertility potential as naturally as possible. When women’s health is restored to its maximum potential, everything is possible,” concludes Gutierrez.