Lucid Diagnostics Eyes Medicare Catalyst for EsoGuard Growth

Key Points

• Medicare coverage is Lucid Diagnostics’ key near-term catalyst. The company is awaiting a draft MolDX local coverage determination for EsoGuard; a final positive policy could enable reimbursement and unlock a potential several-million-dollar backlog of retrospective claims.
• Lucid is shifting its commercial strategy toward physicians, health systems and Medicare patients after completing approximately 60,000 tests. It is also pursuing coverage and contracts with commercial payers and dozens of Veterans Affairs centers, where the stated rate matches Medicare’s $1,900 reimbursement.
• EsoGuard is positioned as a less-invasive triage test for Barrett’s Esophagus, with about 95% of patients able to swallow the collection device and more than 85% of patients with positive results completing follow-up endoscopy. Lucid says testing costs are currently below $200, supporting potentially attractive economics if volume scales.

Lucid Diagnostics NASDAQ: LUCD is positioning its EsoGuard test as a non-invasive tool to identify Barrett’s Esophagus, a precancerous condition associated with esophageal cancer, while it awaits a key Medicare coverage decision and expands relationships with commercial payers, the Department of Veterans Affairs and health systems.

Speaking at Canaccord’s Community Growth Conference, Chief Executive Officer Lishan Aklog said esophageal cancer carries a high mortality rate and that preventing deaths depends on identifying precancerous conditions before cancer develops. He described EsoGuard as a next-generation sequencing molecular diagnostic test performed using a sample collected during an approximately 45-second office procedure.

Aklog said the test is intended to serve as a triage tool for patients at risk of Barrett’s Esophagus. According to the CEO, the existing standard of care is upper endoscopy, but patient compliance with that procedure has been low. Lucid’s approach is designed to provide a less invasive option for identifying patients who should undergo follow-up endoscopy.

Commercial strategy shifts toward physicians and health systems

Lucid has completed about 60,000 tests to date and has targeted quarterly testing volumes of roughly 2,500 to 3,000 tests, Aklog said. Earlier commercial efforts emphasized health fairs and testing events, including programs with fire departments, to generate volume with a limited sales force.

The company is now gradually shifting toward more traditional physician engagement as it prepares for a potential Medicare coverage milestone. Aklog said Lucid has been enhancing the seniority of its commercial team and increasing its focus on patients covered by Medicare, who represent about half of the target population.

He also highlighted health systems as a longer-term commercial channel. Lucid has been working on electronic health record integration and related programs, he said, noting that health-system sales cycles can be lengthy but that the company expects its groundwork to support future volume growth if Medicare coverage is obtained.

Aklog said existing clinical guidelines identify approximately 30 million people as candidates for testing under the company’s interpretation of risk criteria. He said the company’s confidence in potential adoption is based both on that defined patient population and its experience working with hundreds of gastroenterologists, surgeons and primary care physicians.

Coverage progress with commercial plans and VA

Lucid recently announced a positive coverage policy from Concert, a laboratory benefit manager that Aklog said represents client plans covering roughly 9 million lives. Three plans had adopted and publicly posted the policy, with additional plans potentially following, he said.

Separately, Aklog said UnitedHealth and Cigna published upper-endoscopy policies that identify a positive EsoGuard result as an appropriate indication for endoscopy. While those policies do not constitute molecular diagnostic coverage policies, Lucid plans to use them in discussions with the insurers regarding contracting.

The company is also pursuing Veterans Affairs business after EsoGuard was placed on the federal supply schedule. Aklog said the VA rate matches Medicare’s rate, which he said is $1,900. Lucid is working with individual VA centers and has a pipeline involving dozens of centers, although contracts and revenue take time to develop and can be influenced by federal budgeting cycles.

“We do expect in the coming quarters to start seeing revenue directly from that activity as contracts start coming in,” Aklog said.

Medicare decision remains central catalyst

Lucid is awaiting a draft local coverage determination, or LCD, from Medicare’s MolDX program. Aklog said the company submitted a request for reconsideration after assembling its clinical evidence package in 2024. A clinical advisory committee meeting followed in September, involving 11 physicians, according to Aklog.

He said the company believes the evidence and advisory discussion supported EsoGuard’s role as a triage test, but that the process has taken longer than expected because of administrative backlogs at MolDX and the Centers for Medicare & Medicaid Services.

Aklog said a draft LCD converting the existing non-coverage policy into a coverage policy would be the key near-term milestone. A draft policy would still need to undergo a comment period and become final before payment begins. Once a final policy is in place, he said Lucid would be able to submit claims for testing performed during the prior year. The company estimates its potential retrospective claims backlog is in the several-million-dollar range.

Lucid has raised capital to extend its operating runway as the reimbursement process has continued, Aklog said. If coverage creates a clearer growth trajectory, he said the company would have an opportunity to seek growth capital to expand its commercial organization.

Test economics and patient experience

Aklog said the company’s current cost to manufacture the collection device and perform the test is below $200, and that costs could decline to the low hundreds at scale through automation and laboratory efficiencies. He said Lucid believes it can protect its Medicare reimbursement rate in commercial negotiations, though commercial payment rates are negotiated individually.

On patient use, Aklog said approximately 95% of patients are able to swallow the cell-collection device, while about 5% have difficulty swallowing pills. He added that more than 85% of patients with a positive EsoGuard result complete a follow-up endoscopy.

For now, Lucid is focusing its internal resources on the U.S. market despite receiving international interest from potential distributors and other parties, Aklog said.

About Lucid Diagnostics (NASDAQ:LUCD)

Lucid Diagnostics is a molecular diagnostics company focused on improving early detection of oral and oropharyngeal cancers. The company's flagship offering, the LucidDx Oral Cytology Brush Test, combines a minimally invasive brush biopsy tool with proprietary laboratory analysis to identify cellular abnormalities indicative of malignancy. Samples collected in dental and medical offices are sent to Lucid's CLIA-certified and CAP-accredited laboratory, where advanced imaging and cytopathology workflows generate diagnostic reports for clinicians and patients.

Since commencing commercial operations, Lucid Diagnostics has worked to integrate its testing platform into dental practices, oral surgery clinics and ENT specialists across the United States.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to contact@marketbeat.com.

Continue following MarketBeat

Add MarketBeat as your preferred source on Google to see our latest stories in your feed.

Add As Preferred Source