This section highlights FDA-related milestones and regulatory updates for drugs developed by PAVmed (PAVM).
Over the past two years, PAVmed has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
EsoCheck, EsoGuard, and MolDX. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
EsoCheck - FDA Regulatory Timeline and Events
EsoCheck is a drug developed by PAVmed for the following indication: Esophageal Cell Collection Device.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- EsoCheck
- Announced Date:
- March 27, 2025
- Indication:
- Esophageal Cell Collection Device
Announcement
Lucid Diagnostics and subsidiary of PAVmed Inc. announced a campaign, entitled "Embrace the Future", designed to showcase its groundbreaking EsoCheck® Esophageal Cell Collection Device, with Collect+Protect™ Technology, to gastroenterologists and the broader medical community.
AI Summary
Lucid Diagnostics Inc., a subsidiary of PAVmed Inc., has launched a campaign called "Embrace the Future" to highlight its innovative EsoCheck® Esophageal Cell Collection Device featuring Collect+Protect™ Technology. The campaign is designed to engage gastroenterologists and the wider medical community by demonstrating a breakthrough in noninvasive esophageal cell collection that is both safe and efficient. Testing in nearly 30,000 patients shows a fast, office-based procedure performed in under three minutes with an outstanding safety record and high patient satisfaction.
The campaign will coincide with Esophageal Cancer Awareness Month in April and will be prominently featured at the Digestive Disease Week (DDW) Conference in May 2025. Lucid Diagnostics is leveraging this opportunity to spotlight the device’s success in detecting early precancerous changes, positioning it as a modern, reliable alternative to older cell collection methods.
Read Announcement
EsoGuard - FDA Regulatory Timeline and Events
EsoGuard is a drug developed by PAVmed for the following indication: Esophageal DNA Test.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- EsoGuard
- Announced Date:
- April 24, 2025
- Indication:
- Esophageal DNA Test
Announcement
Lucid Diagnostics announced positive data from a National Cancer Institute (NCI)-sponsored study demonstrating that its EsoGuard® Esophageal DNA Test can effectively detect esophageal precancer (Barrett's Esophagus or BE) among at-risk patients without symptoms of chronic gastroesophageal reflux disease (GERD), such as heartburn.
AI Summary
Lucid Diagnostics announced positive results from a National Cancer Institute–sponsored study showing that its EsoGuard® Esophageal DNA Test can effectively detect Barrett’s Esophagus—a precancerous condition—in patients at risk, even when they do not show symptoms of chronic gastroesophageal reflux disease (GERD) such as heartburn. The study, conducted at Case Western Reserve University and University Hospitals, enrolled patients who met screening guidelines despite lacking GERD symptoms. The test achieved a 100% negative predictive value, demonstrating its strong ability to rule out esophageal precancer in those without the disease. Additionally, the study found a Barrett’s Esophagus prevalence of 8.4% in these asymptomatic patients, a rate comparable to that in patients with GERD. These findings support expanding the use of EsoGuard® to a broader patient group, which could greatly increase its market potential for early detection and prevention of esophageal cancer.
Read Announcement- Drug:
- EsoGuard
- Announced Date:
- March 13, 2025
- Indication:
- Esophageal DNA Test
Announcement
Lucid Diagnostics and subsidiary of PAVmed Inc. announced that Highmark Blue Cross Blue Shield, an independent licensee of the Blue Cross and Blue Shield Association, has issued a positive coverage policy for non-invasive screening of esophageal precancer and cancer in New York state.
AI Summary
Lucid Diagnostics, a subsidiary of PAVmed Inc., announced that Highmark Blue Cross Blue Shield has issued a positive coverage policy in New York state for non-invasive screening of esophageal precancer and cancer. The policy specifically includes coverage for Lucid’s EsoGuard® Esophageal DNA Test, which is used to screen patients who meet specific criteria for early detection. This decision is seen as a significant milestone for Lucid Diagnostics, as it validates the strong clinical evidence supporting their DNA test. The company believes that this favorable decision by a prominent commercial insurer will pave the way for similar policies from other insurers, potentially expanding access to early screening methods for esophageal conditions.
This development is a promising step forward in efforts to improve early detection and prevention of esophageal cancer, especially among patients with a history of gastroesophageal reflux disease.
Read Announcement- Drug:
- EsoGuard
- Announced Date:
- December 11, 2024
- Indication:
- Esophageal DNA Test
Announcement
PAVmed Inc. nnounced that the manuscript for its CLinical Utility of EsoGuard (CLUE) study has been accepted for publication in the peer-reviewed journal Medicina.
AI Summary
PAVmed Inc. announced that the manuscript for its CLinical Utility of EsoGuard (CLUE) study has been accepted for publication in the peer-reviewed journal Medicina. The study highlights the strong clinical performance of the EsoGuard® Esophageal DNA Test in screening for esophageal precancer. Researchers found that 100% of patients who received a positive EsoGuard result were referred for a confirmatory upper endoscopy, while over 99% of those with a negative result did not need further invasive testing. Remarkably, 85% of patients with a positive test complied with their doctor’s recommendation to undergo an upper endoscopy. This real-world study, conducted across eight clinical centers with a total of 502 participants, reinforces the test’s effectiveness as a non-invasive triage tool. The publication further supports PAVmed’s evidence base and its discussions with payors and stakeholders regarding esophageal cancer prevention.
Read Announcement- Drug:
- EsoGuard
- Announced Date:
- August 20, 2024
- Indication:
- Esophageal DNA Test
Announcement
Lucid Diagnostics and subsidiary of PAVmed Inc. announced the peer-reviewed publication of an analytical validation study of its EsoGuard® Esophageal DNA test for the diagnosis of esophageal precancer (Barrett's Esophagus or BE) and esophageal adenocarcinoma (EAC) on samples collected non-endoscopically using Lucid's EsoCheck® Esophageal Cell Collection Device.
AI Summary
Lucid Diagnostics Inc., a subsidiary of PAVmed Inc., announced the peer-reviewed publication of an analytical validation study for its EsoGuard® Esophageal DNA test. This test is designed to diagnose esophageal precancer, including Barrett's Esophagus, and esophageal adenocarcinoma. It uses samples collected through a non-invasive procedure with Lucid’s EsoCheck® Esophageal Cell Collection Device.
The study, published in the journal Diagnostics, shows that the test has excellent analytical accuracy, repeatability, and reproducibility. It demonstrated an analytical sensitivity of 89%, analytical specificity of 100%, an accuracy of 96%, and complete precision in both inter- and intra-assays. The test uses next-generation sequencing to detect DNA methylation at 31 specific sites on the genes VIM and CCNA1, which are linked to the progression of esophageal disease.
Read Announcement- Drug:
- EsoGuard
- Announced Date:
- August 6, 2024
- Indication:
- Esophageal DNA Test
Announcement
Lucid Diagnostics and subsidiary of PAVmed Inc. announced the release of new real-world data from its ENVET-BE study supporting the clinical utility of the EsoGuard® Esophageal DNA test as a non-invasive triage tool to significantly increase the positive yield of invasive upper endoscopy (EGD) for detection of esophageal precancer (Barrett's Esophagus or BE) and cancer.
AI Summary
Lucid Diagnostics, a subsidiary of PAVmed Inc., recently released new real-world data from its ENVET-BE study. The study shows that the EsoGuard® Esophageal DNA Test can serve as a non-invasive triage tool to significantly boost the positive yield of invasive upper endoscopy (EGD) when screening for esophageal precancer and cancer, including Barrett’s Esophagus (BE). Patients who tested positive with EsoGuard and were then referred for EGD had a 2.4-fold increase in detection rates compared to what is expected with EGD alone. These findings suggest that incorporating EsoGuard into screening protocols may help identify more at-risk patients. The data supports the clinical utility of the test and aligns with professional guidelines that endorse non-endoscopic biomarker tests as effective alternatives, potentially leading to earlier diagnoses and improved patient outcomes.
Read Announcement- Drug:
- EsoGuard
- Announced Date:
- July 2, 2024
- Indication:
- Esophageal DNA Test
Announcement
Lucid Diagnostics subsidiary of PAVmed Inc announced positive data from its ESOGUARD BE-1 prospective, international, multicenter, single-arm study conducted to clinically validate performance of the EsoGuard® Esophageal DNA test on samples collected with the EsoCheck® Esophageal Cell Collection Device for detection of esophageal precancer (Barrett's Esophagus or BE) and esophageal adenocarcinoma (EAC) in a screening population.
AI Summary
Lucid Diagnostics, a subsidiary of PAVmed Inc., announced positive results from its ESOGUARD BE-1 prospective, international, multicenter, single-arm study. The study clinically validated the EsoGuard® Esophageal DNA test, which uses the EsoCheck® Esophageal Cell Collection Device, to detect esophageal precancer conditions such as Barrett’s Esophagus (BE) and esophageal adenocarcinoma (EAC) in a screening population.
The study involved 93 high-risk individuals at leading academic centers and showed a sensitivity of 87.5% for BE and a negative predictive value (NPV) of 98.6%. These findings confirm the test’s strong clinical performance in non-endoscopic screening for early signs of esophageal precancer. By enabling early detection, the EsoGuard test may help improve patient outcomes by guiding appropriate follow-up procedures and reducing progression to advanced stages of esophageal cancer.
Read Announcement
MolDX - FDA Regulatory Timeline and Events
MolDX is a drug developed by PAVmed for the following indication: For EsoGuard® Esophageal DNA Test.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MolDX
- Announced Date:
- November 20, 2024
- Indication:
- For EsoGuard® Esophageal DNA Test
Announcement
Lucid Diagnostics subsidiary of PAVmed Inc. announced that it has submitted its complete clinical evidence package for its EsoGuard® Esophageal DNA Test in support of a Request for Reconsideration of Local Coverage Determination (LCD) L39256 "MolDX: Molecular Testing for Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and Neoplasia" to Molecular Diagnostics Program (MolDX), administered by Palmetto GBA, a Medicare Administrative Contractor (MAC) for the Centers for Medicare & Medicaid Services (CMS), to seek coverage for EsoGuard.
AI Summary
Lucid Diagnostics, a subsidiary of PAVmed Inc., has submitted its complete clinical evidence package for the EsoGuard® Esophageal DNA Test. This submission supports a Request for Reconsideration of Local Coverage Determination (LCD) L39256 to the Molecular Diagnostics Program (MolDX), which is administered by Palmetto GBA on behalf of CMS. The goal is to secure Medicare coverage for the test.
The evidence package includes six new peer-reviewed publications—three clinical validation studies, two clinical utility studies, and one analytical validation study. Lucid Diagnostics believes this data strongly demonstrates EsoGuard’s clinical validity, utility, and accuracy in detecting esophageal precancer conditions. The company hopes that a successful reconsideration will expand access to early detection testing for at-risk Medicare beneficiaries, marking a significant step forward in cancer prevention diagnostics.
Read Announcement
Free PAVM Stock Alerts