Last February, a baby named KJ Muldoon received a groundbreaking treatment for a rare genetic disorder called CPS1 deficiency, which previously had a dire prognosis. Doctors at the Children’s Hospital of Philadelphia and the University of Pennsylvania sequenced his DNA, designed a custom gene editor, and infused it into his bloodstream. This marked the first successful application of gene-editing therapy tailored specifically for an individual’s mutation. The entire process took about six months and cost under $1 million. Today, KJ is thriving, highlighting the potential of genetic surgery to address rare genetic conditions. Despite the promise of genetic surgery, regulatory challenges remain. The FDA currently treats gene editors aimed at specific mutations as novel therapies, requiring lengthy and costly clinical trials for each one, even if the components have been previously validated. This poses a significant barrier, especially since many rare diseases have only a handful of cases, making it financially unviable for companies to invest in R&D for each mutation. The FDA has proposed new pathways to facilitate the approval of personalized therapies for ultra-rare diseases based on smaller clinical trials, citing KJ’s case as a model. The article suggests a shift in how genetic surgery could be regulated, comparing it to surgical procedures rather than traditional therapeutics. Just like open-heart surgery is overseen without the need for product-by-product approval, a new regulatory framework could be developed for genetic interventions. This approach, termed the Standards for Advanced Genetic Editing (SAGE), would certify centers capable of designing personalized genetic interventions, allowing for the use of validated platforms without requiring individual edits to go through the standard FDA approval process. This could streamline the path for delivering life-saving treatments to patients with rare genetic disorders, while still emphasizing safety and efficacy.