EsoCheck Receives 510(k) Clearance

New Barrett’s esophagus screening method provides minimally invasive endoscopy alternative

Innovations in Digestive Health | Fall 2019

Moving a medical device from discovery to regulatory review takes years of research, data analysis and paperwork. EsoCheck, a new screening method for Barrett’s esophagus (BE) detection, made it through thanks to the dedication of University Hospitals physicians and researchers.

In August 2019, University Hospitals Cleveland Medical Center, Case Western Reserve University, and Pavmed Inc. (Nasdaq: PAVM) subsidiary Lucid Diagnostics announced that EsoCheck received 510(k) clearance from the Food and Drug Administration for clinical use. Lucid Diagnostics will manufacture and market the device.

The device was co-invented by Amitabh Chak, MD, gastroenterologist, University Hospitals Digestive Health Institute; and Professor of Medicine, Case Western Reserve University School of Medicine; Sanford Markowitz, MD, Ph.D., Ingalls Professor of Cancer Genetics, School of Medicine, and head of National Institutes of Health (NIH)/Case Western Reserve University GI Cancers SPORE (Specialized Programs of Research Excellence); and Joseph E. Willis, MD, Pathology Vice-Chair for Clinical Affairs, UH Cleveland Medical Center; and Professor, Department of Pathology, School of Medicine. All three are active members of the Case Comprehensive Cancer Center, which supported the collaboration and the development of this technology.

TESTING FOR BARRETT’S ESOPHAGUS

Barrett’s esophagus is the precursor lesion of esophageal adenocarcinoma (EAC), a cancer with more than 80 percent mortality at five years. BE is one of the more serious complications of gastroesophageal reflux disease (GERD). About 10 percent of people with GERD develop Barrett’s esophagus.

Because BE symptoms mirror those of GERD, many people with BE don’t know they have it. Before EsoCheck, the only way to test for BE was with endoscopy, which is expensive and invasive and requires sedation.

EsoCheck is a noninvasive solution that’s easier to swallow for patient and physician alike. The patient swallows a pill-sized capsule attached to a thin silicone catheter. After delivery of the capsule to the stomach, the physician injects air into the catheter to inflate a balloon inside the capsule. The physician then maneuvers the inflated balloon to swab the lower esophagus near the stomach – the region where BE begins – to obtain a sample of the lining cells. The balloon’s surface texturing allows it to grab the cells. As the physician brings the balloon back up the esophagus, the balloon deflates and inverts back into the capsule. This method protects the esophagus sample from dilution or contamination.

After retrieving the capsule through the mouth, a clinician extracts DNA from the balloon surface and tests it for aberrant DNA methylation that indicates BE. Helen Moinova, PhD, Instructor of Medicine, School of Medicine, study first author and instructor at the School of Medicine, led a parallel effort within the Markowitz laboratory to identify DNA changes diagnostic of BE. Using genome-wide sequencing approaches, Moinova identified two genes, VIM and CCNA1, that each get chemically modified by DNA methylation in BE.

Moinova’s DNA methylation test was more than 90 percent accurate in detecting BE or recognizing an esophagus as normal in patient samples collected by Dr. Chak’s multicenter team from the NIH’s BETRNet (Barrett’s Esophagus Translational Research Network) using EsoCheck.

Lucid Diagnostics is commercializing the DNA test used to identify BE biomarkers under the name EsoGuard. EsoGuard has completed Clinical Laboratory Improvement Amendments (CLIA) certification and is available as a laboratory developed test (LDT) from the UH hospital system clinical laboratory, which developed the test. However, Lucid decided to transfer EsoGuard LDT to a high-capacity commercial laboratory before marketing and full commercial launch. The validation testing to establish EsoGuard as an LDT under this commercial laboratory’s CLIA/CAP (College of American Pathologists) certificate has begun. Once this transfer is complete, Lucid will initiate a full commercial launch of EsoGuard LDT.

Lucid has also secured a Current Procedural Terminology (CPT) reimbursement code for the EsoGuard LDT from the American Medical Association under the Proprietary Laboratory Analyses process. Additional hurdles cleared include technical advisory review, the CPT Editorial Panel, the Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Fee Schedule (CLFS) Annual Public Meeting and the CLFS panel. Most recently, Lucid has secured an in-person meeting with CMS to discuss the EsoGuard LDT code reimbursement rates. 

Under sponsorship from the SPORE and BETRNet programs, supported by and housed within the Case Comprehensive Cancer Center, Dr. Chak led a clinical trial to understand patients’ responses to the screening method. After 86 individuals were tested, 82 percent reported little to no anxiety, pain or choking. Most patients (93 percent) said they would repeat the procedure, and 95 percent said they would recommend the test to others.

‘BETR’ THROUGH INNOVATION

With the arrival of EsoCheck, patients will have a way to get screened for BE that’s as easy as swallowing a vitamin. Support from UH, as well as SPORE and BETRNet, helped bring the team’s vision to reality.

“We are fortunate to be the only academic medical center in the country to which the NIH has awarded both a GI Cancers SPORE and a BETRNet program,” Dr. Markowitz said in a UH press release. “The $18 million in support from these NIH awards has allowed us to build a premier team for developing new approaches for early detection, prevention and treatment of GI cancers. However, credit for this advance most importantly belongs to each of the patients who so generously participated in the clinical trial of this exciting new technology.”

“Our accomplishments show UH’s strength in drug and device development,” says Dr. Chak. “Leadership is committed, involved and encouraging of this and other projects.”

If you have patients who may be candidates for EsoGuard/EsoCheck, contact PavMed at info@pavmed.com.

To learn more about GERD and BE-related research programs, contact Wendy Brock, RN, at 216-544-1976.