Dr. Jaime Shamonki, Chief Medical Officer, Generate Life Sciences
Infertility is on a rising trend in the global populace, with an increasing number of patients undergoing fertility treatments. On a parallel note, striking advances in assisted reproductive technology (ART) and genetic testing have evolved alongside to improve the reproductive outcomes of infertile couples. However, there is a lack of access, understanding, and utilization of genetic data and the availability of comprehensive ART services. In this context, Generate Life Sciences is bridging the gap between life and technology with a spectrum of reproductive and genetic services under one roof for families embarking on their reproductive journey. “We are on a mission to help people build and protect their families through our advanced services starting from the preconception planning phase through birth and into the future,” states Jaime Shamonki, MD, Chief Medical Officer of Generate Life Sciences. To this end, Generate Life Sciences has brought together the largest and the oldest sperm bank, egg bank, and private stem cell bank to provide people with access to high-quality services needed to confidently build and protect their family’s future.
Dr. Shamonki draws attention to a few different themes in genetics as a precursor to their services portfolio. The sequencing of the genome resulted in an exponential increase in the amount of genetic data available and a number of genetic tests. Although this is a significant driver of healthcare decisions, in the wake of the explosion in carrier screening and preimplantation genetic testing at several decision points, physicians find it complicated and burdensome to ascertain which tests to order, eliciting the consent and interpreting results. Moreover, not all tests are of equal clinical value. “This led us to offer genetic testing services, backed by Sema4, a genetic testing and health intelligence company, to add value and actionable information for consumers and healthcare providers,” adds Dr. Shamonki.
Right on the heels of the access to inexpensive and scalable sequencing came the explosion in direct to consumer (DTC) testing. However, on the flip side, the quality of testing methodology employed by DTC companies varies, which results in a very high false-negative rate for certain genetic mutations that consumers don't necessarily know about.
Revolutionizing Genetic Testing
Last year, Generate Life Sciences introduced a customer-driven test called ReadyGen, which requires only a cheek swab to test children for more than 200 conditions with high morbidity and mortality rates that can manifest in childhood. The goal is to detect conditions such as atypical epilepsy, glycogen storage diseases, or certain childhood cancers in the early stages so that parents and pediatricians can take proactive steps to address the disease and prevent potentially nonreversible or debilitating symptoms before they happen.
We are on a mission to help people build and protect families through our advanced services starting from the preconception planning phase through birth and into the future
It is revolutionary for parents, and a huge contrast to the traditional state covered newborn screening with far more conditions being detected. ReadyGen also includes pharmacogenetic analysis of children's responses to 40 medications that helps parents learn early on whether their child is likely to experience side effects or sensitivity to a particular medication.
ReadyGen is adding to the company’s already available robust genetic screening on the gamete donor front. The company has introduced expanded carrier screening panels for all of its donors, screening them for over 280 recessively inherited single-gene diseases. In case the potential sperm donor tests positive for a single gene disorder, then a parallel testing panel can be initiated for the female recipient. This will ensure that they are not recessive carriers for the same disease and mitigate the risk for the child to inherit that condition. Generate Life Sciences’ team of certified genetic counselors helps people through the difficult process of understanding their own genetics and carrier status and finding a suitable donor.
Amidst all the incredible innovations, as per Dr. Shamonki, what sets them a notch higher is the personal and not transactional relationship that has led to establishing life-long relationships with their clients. Their new genetic testing products, innovations aimed at improving the quality of life for a gamete conceived individual, or participation in stem cell research is nothing but a reflection of their uniqueness in their quest to protect families and children for years to come.
On the Innovation Fast Track
At Generate Life Sciences, any new technological advancement is viewed through the lens of whether it is meaningful to people and meets their scientific and technical criteria for excellence. As more innovations are set to take off from the drawing board, the next is to offer DNA based ancestry for organic donors. “When millions of people began participating in DTC ancestry testing, we immediately thought about the potential unintentional impact to the privacy of people involved in donor conception, including donors, recipients and donor-conceived persons of all ages. We wanted to find a way to provide the donor-conceived with this important genetic-based ancestral information without them having to trade their privacy for access” explains Dr. Shamonki.
Created in partnership with Sema4, and akin to AncestryDNA and 23andMe, the DNA based donor ancestral background for all of the gamete donors will be available for free in the donor’s record. Iterative advancements on the genetic testing side will include simple improvements such as offering free DNA storage for newborn stem cell clients so that they can order HLA testing for their child, add ReadyGen without even needing to send a sample, or access iterative improvements in the panel.
However, the big plan, for now, is to leverage their extensive research in regenerative medicine and establish partnerships to get the newborn stem cells into clinical trials to treat the symptoms of COVID-19.