When Research Leaves You Out: How Geno.Me’s Britt Gottschalk is Changing the Clinical Trial Game
Imagine this: You’re prescribed a medication for a serious condition—say a rare disease or a certain type of cancer—only to discover it was primarily tested on a narrow subset of the population. Without data reflecting your unique genetic or health makeup, no one can say for sure how effective it will be for you. This mismatch in clinical research, where many trials skew towards homogeneous demographics, can leave entire groups underrepresented, underserved, and without effective care. The result? Less effective treatments and a slower path to real medical breakthroughs. In fact, the U.S. FDA did not mandate that women and minorities be included in clinical research until 1993: effectively leaving out broad swaths of the population whose bodies react differently to different treatments.
For Britt Gottschalk, this gap in genetic data was more than just a footnote; it was a call to action. While consulting with clinical researchers at major universities and speaking with feasibility teams in pharma, she realized that the people most in need of cutting-edge treatments—often those in marginalized communities—were the least likely to be included in research. Determined to change that, Britt founded Geno.Me, a proprietary data exchange platform designed to democratize research by linking individuals’ genetic reports with their electronic health records while putting patients in control of when and how their data is used. By putting the patient at the center, Geno.Me makes it possible for researchers to develop treatments that truly reflect—and ultimately serve—the diverse world we live in.
Read on for our conversation with Britt, where she discusses the inspiration behind Geno.Me, the realities of creating a more inclusive clinical research landscape, and her vision for a future where diverse genetic data drives better healthcare outcomes for everyone.
Britt Gottschalk, founder & CEO of Geno.Me
Was there a specific moment when you realized the genetic and health data gap was a major problem? What made you want to solve it?
BG: That’s a great question. When you’re coming up with solutions to big problems, you spend a lot of time researching which ones make the most sense to tackle. In my initial conversations with clinical researchers, particularly those in academic settings, it became clear that there was a major gap in genetic data.
As precision medicine grows—along with fields like pharmacogenomics, pharmacokinetics, and pharmaco-oncology—it’s becoming more evident that we’re missing a full picture of an individual without both genetic and environmental data. Electronic health records (EHRs) give us insight into a person’s medical history and environmental exposures, but they don’t tell us what someone was born with. Genetic data fills in that missing piece.
This is especially critical for oncology and rare diseases. Research now suggests that around 80% of cancers have a genetic predisposition. If companies developing drugs and treatments only have access to health record data without genetic insights, they’re not truly treating the whole patient.
For people who don’t work in clinical research, can you explain how the lack of representation impacts real patients?
BG: It comes down to not fully understanding how drugs affect people who weren’t included in clinical trials. Right now, a lot of drug efficacy data skews toward middle-aged white men. That’s largely because this demographic has more access to regular healthcare, insurance, and clinical trial participation.
But the issue goes beyond race—it also includes gender and other factors. Without diverse data, we don’t get a full understanding of how treatments work across different populations.
A tragic example of this was the Johnson & Johnson COVID vaccine. After it was administered widely, we started seeing cases of myocarditis (heart inflammation) occurring in African American men at higher rates. If the clinical trial data had included a more representative sample of the population, this might have been caught earlier. Instead, we had to react after the vaccine was already distributed. This is why inclusive data collection matters—it saves lives.
Could you speak more about what’s driving this lack of participation among marginalized communities and how it impacts overall research?
BG: Yes—there’s a social component to this, too. A major reason we don’t have as much data on minority populations is because of systemic barriers to care. Many people simply don’t have access to quality healthcare, whether due to a lack of local clinics, financial constraints, or other socioeconomic factors.
There’s also a long history of medical mistrust, particularly within the African American community, due to past abuses in medical research. That distrust still affects participation in clinical trials today. Addressing these challenges means not only improving access to care but also rebuilding trust in the research process.
How does Geno.Me change the way researchers access the genetic and health data they need while ensuring privacy? And why hasn’t this been done before?
BG: Typically, researchers go directly to health systems to access patient data. But there’s one key person missing in that process: the patient.
What makes Geno.Me different is that we put the patient at the center. Our platform allows researchers to target specific populations across the U.S., which isn’t always possible within a single health system. We obtain direct consent from participants when they sign up, allowing us to recontact them for additional data or clinical trial opportunities.
We’re also integrated with major EHR systems like Epic, Cerner, and Meditech, which cover about 80% of all medical records. This means that no matter where a person’s records are stored—whether they switch providers or move to a different health system—our platform ensures that their data remains accessible in a way that protects privacy and supports research.
Can you share a story about how Geno.Me is providing data to make a difference?
BG: Right now, our data is primarily being used by recruitment and pharmaceutical companies to identify candidates for clinical trials. They access records from our platform to determine who might be a good fit for a particular study. Contributors on the platform are in control of opting in to be contacted for clinical trial opportunities so ultimately both the fit and the interest helps expand participation and improve trial diversity.
What kinds of diseases or conditions could see the biggest breakthroughs with better diversity in research?
BG: Our primary focus areas of proactively working with patient populations are oncology and rare diseases. Within oncology, we concentrate on breast cancer, blood cancers, and lung cancer, among others. We also explore conditions like lymphoma and prostate cancer.
On the rare disease side, we look at conditions like Alpha-1 Antitrypsin Deficiency (AATD), cystic fibrosis, and carcinoid syndrome. Rare diseases collectively affect around 30 million Americans, but because each condition impacts a relatively small population, they’ve often been underrepresented in research. The conditions that require better diversity are quite broad, however, we plan to expand over time and augment others’ proactive efforts to facilitate health data to better target the best-fit patients.
If a new treatment is developed using data from Geno.Me, what would that mean for everyday people?
BG: It would mean more effective treatments with better outcomes. By incorporating data from traditionally underrepresented populations, we can improve the validity and efficacy of drugs, ensuring that they work for all patients—not just those who historically had access to trials.
There’s been a lot of back and forth in government about diversity in clinical trials, but Geno.Me has been prioritizing this all along. Why is that important?
BG: We’ve always focused on improving diversity in clinical research, but many of the companies we work with have not. That’s why policies like the FDA’s diversity action plan were put in place—to ensure that companies actually hit quotas for diverse representation.
Now, with some diversity requirements being rolled back, we’re seeing two reactions: some companies are doubling down on DEI efforts, while others are deprioritizing diversity because they’re no longer required to focus on it. There are certainly organizations stepping up to provide leadership to demonstrate its continued importance, albeit now with different vocabulary to explain its importance, many are unwavering in their commitment.
After all, science doesn’t change. The people in your clinical trials and research must match the population you intend to treat for those treatments to be safe and effective. It’s also worth noting that women weren’t even required to be in trials until 1993, when the National Institutes of Health’s Revitalization Act mandated their inclusion in NIH-funded studies.
That said, we’re going to continue doing this work regardless of policy changes. It’s not just about DEI—it’s smart business. If you’re creating treatments, it only makes sense to ensure they work for the full population of people who will need them.
How has your partnership with HealthX Ventures influenced your growth, and what unique value has HealthX brought to your mission?
BG: Clinical trials move at an incredibly slow pace in terms of market adoption, because of long and complex sales cycles. To navigate those cycles, it’s important to have a partner like HealthX who understands the nuances of selling in this vertical, and also has the network and relationships to get in the door faster. HealthX recognized that building a platform like ours demands significant upfront capital and a long-term vision. They’ve not only provided the patience and support to refine our model, but also leveraged their network to connect us with the right partners. This has accelerated our growth and ensured our vision can continue to flourish in a challenging market.
If Geno.Me succeeds in its mission, what could this mean for the next generation of medicine?
BG: It means a healthier future. We’ll be able to prevent diseases before they start, develop treatments that work for all people, and improve the overall quality of care. With more representative data, we’re not just creating better research—we’re creating a more equitable healthcare system.
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