ROCHESTER, MINN. NOVEMBER 21, 2022 — Geneticure, a global leader in the genetic variability of response to hypertension treatments, presented data at the 2022 American Heart Association Scientific Sessions meeting from a recent clinical study in which they were able to successfully predict patients who will respond to renal denervation (RDN). In addition, the Geneticure test for renal denervation also identified patients with an increase in blood pressure, following the procedure.
Geneticure genotyped subjects from the Medtronic OFF-MED renal denervation trial to assess the relationship between the genetic scoring and 24hour blood pressure changes from baseline to three months. There was a significant relationship between the Geneticure score and response to renal denervation. When divided into a median split of the Geneticure score, those with a high responder score had a ~14mmHg drop in blood pressure and those with a low score had no change in blood pressure, a statistically significant difference (p<0.001). When dividing the patients into tertiles, the highest tertile demonstrated a drop in blood pressure of ~13mmHg, the middle tertile a drop of ~6mmHg, and the low tertile an increase in BP of ~5mmHg.
Geneticure’s cheek-swab test analyzes genes from organ systems that are known to be important in RDN, which are then entered into a weighted algorithm. Previous studies have demonstrated a range of findings from no difference in RDN compared vs a sham procedure, to just under 5mmHg response vs. sham. More importantly, without genetic screening, RDN shows no clinically meaningful drop in blood pressure (widely considered to be 5 to 10mmHg) when compared to sham in ~30% of patients and an increase in blood pressure post-denervation in ~20% of patients, even in trails that have no medication changes during the study.
“While it’s exciting for market adoption that Geneticure can augment the RDN drop in blood pressure to levels that are clinically meaningful; the company is most excited to be able to identify patients that could have a dangerous increase in blood pressure post-denervation,” said Scott Snyder, Geneticure co founder and CEO.
“These data are critical because all of the recent RDN trials have failed, or shown a relatively low <5mmHg, drop in blood pressure between RDN and sham”, said Dr. Eric Snyder, Geneticure co-founder and COO. “Further, more recent long-term follow-up trials from the ‘real life’ database of patients with radiofrequency ablation have relied heavily on data carried forward from 6, 12, or 24 months to the end of the trial in the sham group, thus leading to an artificial difference in the two groups. This artificial increase in blood pressure in the sham group in these trials is abundantly clear because each trial demonstrates no significant difference in most variables in non-imputed data within the appendix.”