NEW YORK - Lucid (NASDAQ:LCID) Diagnostics Inc. (NASDAQ: LUCD), a medical diagnostics company specializing in cancer prevention, reported significant findings from its ESOGUARD BE-1 study, which validates the performance of its EsoGuard Esophageal DNA test.
The test, used in conjunction with the EsoCheck Esophageal Cell Collection Device, demonstrated an 87.5% sensitivity and 98.6% negative predictive value (NPV) for detecting esophageal precancer and esophageal adenocarcinoma (EAC) in a screening population.
The international, multicenter study, led by Dr. Nicholas J. Shaheen of the University of North Carolina School of Medicine, included prominent institutions such as Baylor College of Medicine and Vanderbilt University. The research, available on the MedRxiv preprint server and pending peer review, supports EsoGuard's potential as a non-endoscopic screening tool for esophageal precancer.
This study follows the peer-reviewed publication acceptance of positive data from a separate screening study at the Cleveland VA, which reported similar NPV and slightly higher sensitivity. These findings, along with previous National Cancer Institute-funded studies, contribute to a robust body of evidence for EsoGuard's clinical validity.
The ESOGUARD BE-1 study's results are timely as Lucid Diagnostics prepares for a pre-submission meeting with Medicare and ongoing discussions with commercial payors. The company's Chief Medical Officer, Dr. Victoria T. Lee, highlighted the consistency of EsoGuard's performance across multiple studies and its potential impact on early detection and prevention of esophageal cancer.
The test was evaluated on 93 subjects who met the American College of Gastroenterology screening criteria, which includes chronic heartburn and additional risk factors such as age over 50, male sex, white race, obesity, smoking, and family history. The study reported a disease prevalence of 8.6%, with no EAC cases identified.
Lucid Diagnostics, a subsidiary of PAVmed Inc . (NASDAQ: NASDAQ:PAVM), emphasizes the ease, safety, and efficiency of the EsoGuard DNA biomarker test, which could lead to increased screening rates and better early disease detection. This approach may ensure that patients receive appropriate surveillance and treatment to prevent progression to EAC.
The company's announcement is based on a press release statement and adds to the dialogue on improving cancer screening methods. Lucid Diagnostics continues to advance its products, aiming to address the needs of patients at risk of developing esophageal precancer due to conditions like GERD.
In other recent news, Lucid Diagnostics reported an impressive 124% year-over-year growth in its first-quarter 2024 revenue, exceeding $1 million. This surge in revenue was accompanied by a 10% increase in test volume from the previous quarter, maintaining at 2,420 tests. Despite slightly missing estimates, the firm's growth was buoyed by an increase in processed test volume, partly due to high-volume testing events.
The company has recently centralized its telehealth services to enhance efficiency and is preparing for a significant meeting with MolDX in July 2024. At this meeting, Lucid aims to present data for a technical assessment to secure coverage for its EsoGuard test under the foundational local coverage determination.
Lucid Diagnostics also highlighted the superiority of its EsoCheck test over EsophaCap, which was recalled in April 2024. The firm's position was reinforced by Canaccord Genuity, which maintained a Buy rating on Lucid, citing optimism about the company's growth prospects and anticipated increased adoption of its diagnostic solutions.
These developments are part of Lucid Diagnostics' recent efforts to strengthen its market position and expand its EsoGuard test as a covered benefit through direct contracting initiatives. With a cash balance of $24.8 million and an additional $11.6 million from financing, Lucid continues to focus on its core market and the potential growth and impact of its EsoGuard test.
InvestingPro Insights
As Lucid Diagnostics Inc. (NASDAQ: LUCD) positions its EsoGuard Esophageal DNA test as a pivotal tool for early detection of esophageal precancer, the financial metrics and analyst outlook provide a vital context for potential investors. According to InvestingPro data, Lucid Diagnostics holds a market capitalization of $41.36 million, indicating its relatively small size within the medical diagnostics market. Despite the company's significant revenue growth of 370.5% over the last twelve months as of Q1 2024, it's important to note that Lucid Diagnostics is not currently profitable and has reported a negative gross profit margin of -111.1% during the same period.
Investors may find the analyst perspective provided by InvestingPro Tips particularly informative. For instance, while analysts anticipate sales growth in the current year, they do not expect the company to be profitable within the same timeframe. Additionally, two analysts have revised their earnings upwards for the upcoming period, which could suggest a positive outlook on Lucid's financial trajectory.
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