Lucid Diagnostics, a subsidiary of medical device company PAVmed, has obtained the US Food and Drug Administration (FDA) breakthrough device designation for its EsoGuard Esophageal DNA Test.
FDA has granted breakthrough device designation for EsoGuard to test esophageal samples collected using the company’s EsoCheck Cell Collection Device, in patients who are at high risk for esophageal dysplasia due to chronic gastroesophageal reflux disease (GERD).
PAVmed chairman, chief executive officer and Lucid executive chairman Lishan Aklog said: “EsoGuard’s FDA Breakthrough Device designation represents a major milestone for PAVmed and Lucid.
“This designation validates our belief that EsoGuard is a groundbreaking technology that has the potential to have as great an impact on esophageal cancer as widespread Pap screening has had in preventing deaths from cervical cancer. We look forward to working closely with the FDA to advance our EsoGuard in-vitro diagnostic (IVD) clinical development program at an expedited pace.”
EsoGuard Esophageal DNA Test is performed on samples collected using EsoCheck Esophageal Cell Collection Device
Lucid said that its products are designed for the diagnosis of Barrett’s Esophagus (BE), with and without dysplasia, associated with oesophageal cancer (EAC), in patients with GERD. EsoCheck is an FDA 510(k) approved oesophageal cell collection device.
EsoGuard is said to work by next generation sequencing (NGS) of bisulfite-converted DNA to detect methylation at 31 sites on two genes, VIM and CCNA1. The test is commercially available as a Laboratory Developed Test (LDT).
Lucid claimed that its EsoGuard test has accurately detected BE, with and without dysplasia, along with EAC, with more than 90% sensitivity and specificity, in a human study on 408 patients.
The company intends to conduct two international multi-center IVD clinical trials, to support an FDA premarketing approval. The study will compare EsoGuard to the gold standard of endoscopy with biopsies, on GERD patients without a prior diagnosis of BE or EAC.
Lucid regulatory consultant Alberto Gutierrez said: “I am very gratified that FDA agreed with us that EsoGuard satisfies all of its criteria for Breakthrough Device designation for the proposed indications for use. I have participated in the designation of several IVD Breakthrough Devices and understand the value this brings to Lucid’s clinical development program.
“I look forward to continuing to work with Lucid and FDA as we take advantage of the enhanced and accelerated FDA engagement opportunities granted to Breakthrough Devices.”
