TEST:

Esopredict™ test

"Previse...today announced the company presented prospective real-world clinical utility data for Esopredict at the 2024 American College of Gastroenterology Annual Scientific Meeting (ACG) being held October 25-30 in Philadelphia, PA and virtually."

Average inter- and intra-assay precision were <9% and <5% coefficient of variation (CV), respectively. These results confirm that EsopredictTM is a highly reproducible, sensitive, and specific risk categorization assay for the prediction of progression to HGD or EAC within 5 years.

The percentage of patients that progress to HGD and EAC increases as risk level increases consistent with the clinical validation data (75% of progressors in high-risk level). The odds ratio (OR) for high-risk to low-risk level is 28 (Prob >Chisq 0.0107) indicating patients with the highest risk level are 28X more likely to progress. Segment length was also evaluated for a subset of samples (n=70) with the information available.

Post-Esopredict clinical recommendations changes to hold, upstage, or downstage care based on each patient's test result risk level were as follows: Low Risk (72%, 11%, and 17%, respectively), Low Moderate (59%, 37%, and 4%, respectively), High Moderate (38%, 50%, and 12%, respectively), and High Risk (27%, 45%, and 27%, respectively). A higher percentage of results fell in Low Risk (26%) and Low Moderate (39%) categories for NDBE patients and High Moderate and High-Risk categories for patients with IND (40% and 40%, respectively) and LGD (38% and 31%, respectively). All participants expressed confidence in decisions based on Esopredict results and that Esopredict provided clinical value in determining a care plan with their patients.

"Previse..announced today that its clinical validation study results for its flagship assay, Esopredict, were published in the American Journal of Gastroenterology (AJG). The publication, "Validation of an Epigenetic Prognostic Assay to Accurately Risk Stratify Patients with Barrett's Esophagus," highlights Esopredict, a first-in-class DNA methylation test for identifying patients with precancerous Barrett's esophagus (BE) who are likely to progress to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) in the future."

These results confirm that Esopredicts highly reproducible and accurate across risk categories to stratify BE patients into low low moderate high moderate or high risk for developing HGD or EAC within 5 years.

"Previse said on Thursday that it has been awarded a $1.8 million grant from the National Institutes of Health to support additional clinical testing of Esopredict, the company's recently launched laboratory-developed real-time PCR test for esophageal cancer risk."

Among 41 patients comprising 105 spatially profiled samples, 21 were non-progressors, and 20 were progressors. Based on each patient’s highest risk score, Esopredict had a sensitivity of 100% and specificity of 67%, with 0 true progressors classified as low-risk. Among 14 patients comprising 54 temporally profiled samples, 7 were non-progressors, and 7 were progressors.

"Previse...announced details on Monday, May 8, of two studies presented during Digestive Disease Week® 2023, held May 6-9 in Chicago. Both analyses clinically validate use of biomarkers to detect and assess risk of esophageal cancer developing in patients with Barrett’s esophagus."

This epigenetic biomarker model has value as a laboratory-developed test to predict future risk of neoplastic progression in BE patients. In our test set, 90% of progressors fell into medium or high risk categories, with 54% in high risk. The ability to risk-stratify BE patients can improve care management by finding high-risk patients who may benefit from increased surveillance or intervention, but also finding low-risk patients who may not need as frequent surveillance.

"Previse, formerly known as Capsulomics, Inc., announced that the company has closed a $3M seed round and launched its first laboratory-developed test, Esopredict™....In addition to launching Esopredict™, Previse also raised a $3M seed round, with participation from TEDCO, Wexford Science and Technology, Riptide Ventures, Gaingels, and numerous angel investors."