NEW YORK – Lucid Diagnostics on Thursday announced that its LucidDx Labs subsidiary has acquired certain licenses and other related assets from ResearchDx enabling it to operate a new CLIA-certified, CAP-accredited clinical laboratory in Lake Forest, California.
In a Form 8-K filed with the US Securities and Exchange Commission, Lucid Diagnostics said LucidDx Labs will pay ResearchDx an aggregate purchase price of up to $6.2 million for the acquired assets.
ResearchDx, the operator of a CLIA-certified, CAP-accredited clinical laboratory in Irvine, California, had performed Lucid’s EsoGuard Esophageal DNA Test from the time of its commercial launch as a laboratory-developed test.
LucidDx Labs said that it has begun performing EsoGuard testing at the Lake Forest laboratory. Testing involves DNA extraction and bisulfite-converted next-generation sequencing of surface esophageal cells collected from at-risk patients with gastroesophageal reflux disease, also known as chronic heartburn or acid reflux, using Lucid’s EsoCheck Esophageal Cell Collection Device.
EsoGuard is a bisulfite converted NGS DNA assay performed on surface esophageal cells collected with EsoCheck which quantifies methylation at 31 sites on two genes, vimentin and cyclin A1. EsoCheck is a swallowable balloon capsule used to sample surface esophageal cells.
“Having our own CLIA/CAP laboratory to perform EsoGuard testing will markedly streamline and simplify numerous important processes, including EsoGuard billing and collections,” Lishan Aklog, Lucid’s chairman and CEO, said in a statement, adding that the new lab also allows the firm to accommodate accelerating growth in testing volume.
LucidDx Labs and ResearchDx have also inked a management services agreement by which ResearchDx will continue to provide personnel and services to support EsoGuard testing at the Lake Forest laboratory. Under the agreement, LucidDx Labs will pay up to $1.8 million in cash in quarterly installments of $150,000 during the 36-month period commencing on Feb. 25. Further, LucidDx Labs has entered an agreement to lease the building that houses the laboratory.
Last October, New York City-based Lucid, a majority owned subsidiary of Pavmed, went public on the Nasdaq at $14 per share.