MolDX Gathers Experts to Review Medicare Coverage for EsoGuard® Esophageal DNA Test

Upcoming Expert Panel Meeting on EsoGuard® Testing

In a pivotal initiative to enhance cancer detection methods, Lucid Diagnostics Inc. has announced a significant meeting to take place on September 4, 2025. This gathering, organized by MolDX-participating Medicare Administrative Contractors (MACs), aims to evaluate the Local Coverage Determination (LCD) for the EsoGuard® Esophageal DNA Test. This test, which holds the potential for early detection of esophageal cancer, represents a crucial step towards advancing healthcare standards in the field of gastroenterology.

The meeting will feature an esteemed panel of medical experts, including representatives from notable institutions like Palmetto GBA, CGS Administrators, Noridian Healthcare Solutions, and WPS Government Health Administrators. These professionals will provide invaluable insights and context regarding the LCD L39256, which focuses on the molecular testing for upper gastrointestinal conditions. The implications of this meeting are profound, especially for the millions of patients suffering from gastroesophageal reflux disease (GERD), who are at an increased risk of developing esophageal precancer.

Lucid Diagnostics, a pioneer in cancer prevention diagnostics and a subsidiary of PAVmed Inc., has been making strides towards making early detection tools accessible to patients. The EsoGuard® test is distinguished for its noninvasive approach, utilizing samples collected through the EsoCheck® Esophageal Cell Collection Device. This method allows healthcare providers to assess the genetic markers associated with esophageal cancer swiftly and painlessly.

Dr. Lishan Aklog, Chairman and CEO of Lucid Diagnostics, expressed gratitude towards the MolDX team for their thorough evaluation of the clinical evidence that underscores the necessity of the EsaGuard® test. “We view this meeting as a critical step towards a favorable outcome for Medicare coverage,” stated Dr. Aklog. He emphasized the consensus among the gastrointestinal community regarding the test's clinical utility, evidenced by guidelines from professional societies and the accumulated experience from nearly 40,000 patients tested to date.

As healthcare continues to evolve and integrate more technological advancements, meetings like the one planned by MolDX will help steer policies that directly impact patient care and treatment modalities. The discussions during the panel will revolve around various clinical studies showcasing the test's efficacy, as well as real-world evidence contributing to its validation.

While the meeting will be open to the public, it’s important to note that public questions will not be entertained, focusing the dialogue squarely on the expert panel discussion. Stakeholders interested in participating in or listening to the discussions are encouraged to register via Microsoft Teams Webinar by September 3, 2025.

Looking forward, Lucid Diagnostics remains committed to its mission of reducing cancer mortality through innovations in medical testing. With the recent advancements in their financial positioning, they are poised to navigate the regulatory landscape effectively and push for wider acceptance and implementation of their groundbreaking diagnostic tools.

In summary, this panel not only signifies a significant push for necessary FDA approval but also reflects a larger commitment within the medical community to embrace innovative solutions that have the potential to save countless lives. The ongoing development and evaluation of technologies like the EsoGuard® test serve as a reminder of the vital role early detection plays in the fight against cancer. As this meeting unfolds in September, the outcomes could well lead to transformative changes in Medicare policy and clinical practice regarding esophageal cancer screening.