Last month, GSK and 23andMe extended a data licensing collaboration for drug target discovery and other research. It’s a partnership that makes sense given 23andMe’s huge, 14 million-person-strong database. But there are other uses for genomics that the healthcare industry hasn’t fully taken advantage of.
“There’s real potential for having genomics-based medicine,” Anne Wojcicki, 23andMe co-founder and CEO, said. “The same way you have genomics-based drug discovery, you can have genomics-based healthcare.”
However, that’s not yet the reality, and there are a number of reasons why.
“The genome is not integrated in healthcare for all kinds of reasons,” Wojcicki said. “Doctors are overwhelmed, doctors are not trained on it, and the reimbursement structure is poor.”
Indeed, an August article in the journal Nature Medicine titled, “We need a genomics-savvy healthcare workforce,” argued that 20 years after the completion of the Human Genome Project, genetics’ “clinical potential can be realized only with the development of a multidisciplinary healthcare workforce.”
Here are three ways pharma and the wider healthcare industry could leverage genomics.
Clinical trial recruitment
The FDA encouraged the use of genomics in clinical research in its “Genomic Sampling and Management of Genomic Data Guidance for Industry,” writing that the “identification of genomic biomarkers underlying variability in drug response may be valuable to optimize patient therapy, design more efficient studies, and inform drug labeling.”
Of course, precision medicine is already aiming to do this, but it could start even sooner and in a more patient-centric manner. For instance, the authors of an article in the journal Genome Medicine argued “next-generation trials need to be patient-centered (i.e., therapeutic agents matched to patients based on their tumor biomarkers) rather than drug-centered (i.e., patients matched to specific clinical trials).”
In addition, trial sponsors could also use genomics to focus clinical trial recruitment. However, the industry isn’t quite there yet.
“I’m always surprised that genetics is not well adopted in clinical trials because you can use genetics to pick the right population to recruit in a clinical study,” Wojcicki said.
Whether it’s efficacy or side effects, people respond to drugs differently. That’s why pharmacogenetics “absolutely makes sense for consumers,” said Wojcicki.
“I think [pharmacogenetics] can really drive a lot of efficiency,” Wojcicki said. “If you know you’re not going to respond to something, why are you taking it?”
In a clinical setting, this information has the potential to help steer prescribing decisions. As the National Human Genome Research Institute writes, it “allows the possibility in some instances of picking the right drug at the right dose for the right person instead of the ‘one size fits all’ approach to drug therapy.”
For instance, if someone is genetically predisposed to statin side effects, they can either start with a different drug or get a heads up to watch for certain symptoms. Wojcicki also believes it could create more targeted prescribing practices for antidepressants, which typically require a trial-and-error approach. But adoption has been slow. Part of the challenge is that having this information may not change prescribing behavior without a broader structure in place, the authors of an article in the journal Genes noted.
“I’m always surprised that genetics is not well adopted in clinical trials because you can use genetics to pick the right population to recruit in a clinical study."
Choosing one drug or another to prescribe “is not necessarily a cost-savings measure” for the larger healthcare industry, Wojcicki also pointed out.
Genomics can be used to predict risk for many conditions, from breast and ovarian cancer to susceptibility to severe COVID-19. But it has the potential to be used for a lot more.
“To date, newborn screening for treatable inherited conditions represents the most successful human genomic application in public health, but population screening across the lifespan for other genetic conditions is increasingly possible,” authors of a paper in the journal Genome Medicine wrote.
Yet insurance and reimbursement is a significant barrier. Wojcicki noted that 20% to 30% of 23andMe customers with the BRCA gene variant that increases risk for certain cancers “never would have qualified for a test.”
Wojcicki also pointed to limited reimbursement structures around prevention in general.
“Prevention is that keyword,” she said. “So many aspects of healthcare today are focused on chronic disease management, and very few are heavily focused on prevention.”