NEW YORK – Although its test for esophageal precancer has been commercially available for years, Lucid Diagnostics has recently published new validation data and refined its reimbursement strategy to boost uptake of its assay.
The firm also last week announced that it raised $22 million in a convertible debt refinancing that will provide a cash runway to get through its upcoming reimbursement milestones.
The company's EsoGuard test, along with its associated EsoCheck Cell Collection Device, is intended to noninvasively screen for precancerous conditions for esophageal adenocarcinoma in at-risk populations. Both technologies were licensed from Case Western Reserve University and EsoCheck received clearance from the US Food and Drug Administration in 2019. Both the test and the cell collection device have also received CE marking.
EsoCheck consists of a capsule with a balloon on the end of a silicon catheter string that a patient swallows. Once it reaches the stomach, the balloon inflates and captures cells from a targeted area of the lower esophagus as it is pulled back up. EsoGuard uses DNA bisulfite conversion, PCR amplification, and next-generation sequencing to determine the methylation status of 31 sites in the vimentin and cyclin A1 genes, which indicate Barrett's esophagus (BE), a precancerous condition for esophageal adenocarcinoma.
An algorithm is then used to calculate the percentage of DNA molecules where proportions of methylated sites on either gene exceed specific thresholds, and if those thresholds are exceeded, the test is positive for either BE or a more advanced condition.
Lishan Aklog, CEO and chairman of Lucid Diagnostics' parent company PAVmed, noted that the company has significantly expanded its clinical evidence base over the past year with validation studies that show consistent performance of EsoGuard across multiple populations.
For example, in a clinical validation study published in May in the American Journal of Gastroenterology that evaluated 243 patients, EsoGuard had overall sensitivity and specificity of 85 percent, with sensitivity of 84 percent for nondysplastic BE. The test also detected 100 percent of esophageal cancers.
A second study published last month in the same journal evaluated 180 male patients and found EsoGuard had sensitivity for BE detection of nearly 88 percent and specificity of 81 percent.
Thus far the company has been building its commercial infrastructure and "kept things at a low- to mid-throttle until we had sufficient data" to make a final push toward widespread reimbursement from the US Centers for Medicare and Medicaid Services and commercial payors.
Last month, Lucid Diagnostics assembled its clinical evidence package and submitted it to Medicare's MolDx program under an existing local coverage determination. That coverage determination currently does not allow for coverage of its test, but Aklog said that's because no existing test had the data to fulfill the coverage criteria.
The LCD from Medicare administrative contractor Palmetto GBA notes that there are no currently existing tests that have demonstrated analytical validity, clinical validity, and clinical utility to fulfill the necessary criteria. However, it adds that Palmetto will "continue to monitor the evidence and may revise this determination based on the pertinent literature and society recommendations."
According to the LCD, a patient receiving the test must be actively managed for chronic gastroesophageal reflux disease and/or nondysplastic BE, have at least three additional risk factors for BE as described in nationally recognized guidelines, and must not have been previously diagnosed with dysplasia or esophageal carcinoma.
Aklog noted that the ACG guidelines recommend screening for precancerous conditions in patients with heartburn and at least three out of six risk factors. Those risk factors include ages older than 50, being White or male, obesity, smoking, and a family history.
Lucid is hoping that once MolDx reviews its submission, the LCD will be reconsidered and changed to one that covers its technology for its intended use in esophageal cancer screening populations.
Lucid first met with MolDx about four years ago and got its test priced at $1,938.01 in 2021, but coverage and reimbursement didn't follow due to a lack of clinical data. MolDx published a final LCD with noncoverage in 2023, and Lucid has spent the last year obtaining sufficient validation and utility data to meet MolDx's requirements for coverage as laid out in that LCD.
Last year, the firm published preliminary utility data in Archives of Clinical and Biomedical Research that found physicians who are ordering EsoGuard commercially are reliably using it as a triage to upper endoscopy for evaluation of patients at high risk of BE or esophageal adenocarcinoma. The positive agreement between EsoGuard results and referral for upper endoscopy was 100 percent, while negative agreement and overall concordance were both 99 percent.
Although there's no concrete timeline for MolDx to reach a decision on coverage for EsoGuard specifically, Aklog said the company's engagement with MolDx has been "extremely positive" over the last few months and believes the coverage reconsideration will come in the near term.
The company is also making progress on the commercial payor side, although many larger commercial payors take their cues from Medicare. While EsoGuard is not in network with the majority of payors, the firm does still submit claims to insurers and undergoes "various adjudication processes and appeals" and gets paid about 20 percent of the time when out of network, he said. The firm currently runs about 12,000 tests per year and posted $1.2 million in Q3 2024 revenues, a 53 percent increase compared to Q3 2023.
Lucid is utilizing strategies beyond traditional reimbursement to get paid, as well, Aklog noted. The company is providing its tests to concierge medicine practices where patients pay a monthly or annual fee for "enhanced access to their physicians" and value-added services, such as more comprehensive diagnostic testing, Aklog said. One area with a "good amount of traction" in the concierge medicine space is early cancer detection, where patients have "strong interest in feeling confident they're not at risk." While its concierge medicine program is relatively new, Aklog said the company is optimistic that patients who utilize these practices may be willing to pay out of pocket for an early detection test that could provide them peace of mind.
The company is also working within the employer-provided health insurance market, including insurance provided by unions and other noncorporate entities. As an example, the firm currently has a program to test firefighters — a particularly high-risk group for esophageal cancer — using EsoGuard at health fairs where samples are collected and then sent back to Lucid's lab for testing. The company has been entering into contracts with employers and unions to provide a certain number of these tests for the portion of their employees or union members that belong to the recommended screening population, Aklog said.
In September, the firm signed a memorandum of understanding with first responder medical care provider Front Line Mobile Health to explore collaboration opportunities to promote EsoGuard among firefighters.
In addition, Lucid is working with third-party benefit brokers that package health and wellness benefit packages for employers to include EsoGuard in their health programs at an agreed-upon price.
Beyond its EsoGuard and EsoCheck products, Lucid is also developing a test using progression markers to help with patients in surveillance programs who currently undergo serial endoscopies every three years. This molecular test would initially serve as a less-invasive supplement to endoscopies, with patients potentially using the test for monitoring in the years between endoscopies.
EsoGuard is intended to "detect all the conditions along the spectrum from the earliest precancer, the nondysplastic patients, all the way to esophageal cancer," he said. In contrast, this new test is intended as a surveillance tool to discriminate between nondysplastic and dysplastic BE.