Back on the podcast today is Jessica Roberts – Professor of Law, Professor of Medicine, and Director of the Health Law & Policy Institute at the University of Houston Law Center – to talk about the emerging set of genetic duties issues related to genetic reclassification.

First question, genetic reclassification? No, it doesn’t mean your genes are changing. But as our understanding of the human genome expands, it means that what we know about how certain genetic variations translate into actionable health information. Genetic variations can be classified on a scale going from pathogenic to likely pathogenic, to likely benign, to benign with a middle area of variants of unknown significance (VUS – pronounced voos, not vee-you-ess). Essentially, genetic reclassification happens when enough new data comes in that it changes how a lab would classify that variation (shifting it from VUS to likely benign, for example).

I’ll steal the hypothetical Prof. Roberts uses in the podcast to explain. A woman in 2020 finds out that she has stage 4 breast cancer. The result is surprising because in 2010 she took a genetic test and the results indicated that she was not a heightened risk for breast or ovarian cancer. But somewhere in those ten years, new data came and the lab that processed her test in 2010 discovered that her genetic variation that they initially classified as, for this example we’ll say likely benign, is actually pathogenic, but she was never notified of the change in classification. Her genes never changed, but the medical community’s understanding of her genes did.

Here’s the “fun” part, this is new. There’s not much policy – legislative, regulatory, or otherwise – around this. It’s a huge can of worms for patients, doctors, labs, and healthcare providers that can be addressed in any number of different ways from granular terms of service and informed consent changes at the lab/doctor level to larger public policy changes that state legislatures can make. We dive into some of Professor Roberts’ thoughts on what policy changes could be made to address these issues.

If you are interested in diving deeper into the topic, check out the Genetic Duties by Professor Roberts and Alexandra Foulkes (forthcoming in the William and Mary Law Review). You can also find more of Jessica Robert’s research and writing on her SSRN page. You can also find more information about Professor Roberts on her University of Houston Law Center faculty page.

As always, if you enjoy the podcast, the best way to show your support is to subscribe to it on Apple Podcasts, Spotify, Stitcher Radio, or wherever you listen to podcasts. if you haven’t already. Another great way to support the show is to leave a 5-star rating and positive review for The CAP⋅impact Podcast on Apple Podcasts.