Lucid Diagnostics Lab Executes Four New Participating Vendor Agreements

NEW YORK–(BUSINESS WIRE)–Lucid Diagnostics Inc. (Nasdaq: LUCD) (“Lucid”, the “Company”) a commercial-stage cancer prevention medical diagnostic company and a majority-owned subsidiary of PAVmed inc. (Nasdaq: PAVM, PAVMZ) (“PAVmed”), today announced that its wholly-owned CLIA-certified and CAP-accredited laboratory, LucidDx Labs Inc. (“LucidDx Labs”), has entered into Participating Provider Agreements with Prime Healthcare Preferred Provider Organizations , Three Rivers Provider Network, and Galaxy Health Network (the “PPOs”), as well as Alivio Health, a network of specialty diagnostic laboratories.

PPOs and Alivio Health collectively provide access to millions of lives through the provider networks they have compiled for their customers, including third-party administrators, insurance companies, self-insured companies, corporations and government entities, to access them. Under the agreements, people covered by OPP and Alivio customers will have networked access to Lucid’s EsoGuard® DNA test, the first and only commercially available test capable of serving as a widespread tool to prevent esophageal cancer deaths through early detection of esophageal precancer in patients at risk for heartburn chronic stomachs. The agreement provides fee-percentage reimbursement rates for services rendered to those covered individuals by LucidDx Labs, including performing the EsoGuard test.

“We are excited to join these provider networks and continue to expand our reach, bringing networked access to EsoGuard Esophageal Cancer Prevention Testing to millions of people covered by their customers and payers,” said Lishan Aklog MD, President and CEO of Lucid. . “Achieving broad commercial reimbursement for EsoGuard testing remains one of our most important near-term strategic objectives and one of the key drivers of value. Our talented and growing market access team will continue to work tirelessly to secure many more such deals spanning millions more lives.

About EsoGuard and EsoCheck

Millions of patients with GERD are at risk of developing esophageal precancer and a highly fatal form of esophageal cancer (“EAC”). More than 80% of EAC patients die within five years of diagnosis, making it the second deadliest cancer in the United States. The mortality rate is high even in people diagnosed with CEA at an early stage. The incidence of CAE in the United States has increased by 500% over the past four decades, while the incidence of other common cancers has declined or remained stable. In almost all cases, EAC progresses silently until it manifests with new symptoms of advanced disease. All EACs are thought to originate from esophageal precancer, which occurs in about 5% to 15% of patients at risk for GERD. Early esophageal precancer can be monitored for progression to late esophageal precancer which can be cured with endoscopic removal of the esophagus, reliably halting progression to cancer.

Screening for esophageal precancer is already recommended by clinical practice guidelines in millions of GERD patients with multiple risk factors, including age over 50, male, Caucasian, obesity, history of smoking, and a family history of esophageal precancer or cancer. Unfortunately, less than 10% of those recommended for screening undergo traditional invasive endoscopic screening. The profound tragedy of a diagnosis of EAC is that the probable death could have been avoided if the patient at risk of GERD had been screened and then subjected to monitoring and curative treatment.

The only missing element for a viable esophageal cancer prevention program has been the lack of a widespread screening tool capable of detecting esophageal precancer. Lucid believes EsoGuard, performed on samples collected with EsoCheck, is the missing piece – the first and only commercially available test capable of serving as a widespread screening tool to prevent esophageal cancer deaths through early detection of esophageal precancer in patients at risk of GERD. A recently updated clinical practice guideline from the American College of Gastroenterology endorses non-endoscopic biomarker testing as an acceptable alternative to expensive and invasive endoscopy for screening for esophageal precancer. EsoGuard is the only such test currently available in the United States.

EsoGuard is a bisulfite-converted NGS DNA test performed on surface esophageal cells collected with EsoCheck that quantifies methylation at 31 sites on two genes, vimentin (VIM) and cyclin A1 (CCNA1). The test was evaluated in a multicenter case-control study involving 408 patients and published in Science Translational Medicine and have shown greater than 90% sensitivity and specificity for detecting esophageal precancer and cancer.

EsoCheck is a non-invasive, FDA 510(k) cleared, CE marked, swallowable balloon capsule catheter device capable of collecting surface esophageal cells in less than five minutes. It consists of a rigid plastic capsule the size of a vitamin pill attached to a thin silicone catheter from which a soft silicone balloon with textured ridges emerges to gently wipe away surface esophageal cells. When vacuum aspiration is applied, the balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside the targeted region upon device removal. Lucid believes this proprietary Collect+Protect™ technology makes EsoCheck the only non-invasive esophageal cell collection device capable of such anatomically targeted and protected sampling. The sample is sent by overnight express courier to Lucid’s CLIA-certified and CAP-accredited laboratory, LucidDx Labs, for EsoGuard testing.

About Lucid Diagnoses

Lucid Diagnostics Inc. (Nasdaq: LUCD) is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc. (Nasdaq: PAVM). Lucid focuses on the millions of patients with gastroesophageal disease (GERD), also known as chronic heartburn, who are at risk of developing esophageal precancer and cancer. EsoGuard by Lucid® Esophageal DNA test, performed on samples taken in a brief, non-invasive office procedure with its EsoCheck® The esophageal cell collection device is the first and only commercially available diagnostic test capable of serving as a widespread screening tool to prevent cancer and cancer deaths through the early detection of esophageal precancer in patients at risk of GERD. EsoGuard is marketed in the United States as a laboratory developed test (LDT). EsoCheck is marketed in the United States as a 510(k) cleared esophageal cell collection device. EsoGuard, used with EsoCheck, has received FDA Breakthrough Device designation and is the subject of several ongoing clinical trials. Lucid is building a nationwide direct sales and marketing team targeting primary care physicians, specialists, and institutions, as well as a network of Lucid Testing Centers where patients at risk for GERD can undergo the EsoCheck procedure for EsoGuard tests. For more information, please visit www.luciddx.com, follow Lucid on Twitter, and connect with Lucid on LinkedIn. For detailed information about EsoGuard, please visit www.EsoGuard.com and follow us on TwitterFacebook and Instagram.

Forward-looking statements

This press release contains forward-looking statements. Forward-looking statements are all statements that are not historical facts. These forward-looking statements, which are based on the current beliefs and expectations of Lucid’s management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. The risks and uncertainties that could cause such differences include, among others, the volatility of the market price of Lucid’s common stock; general economic and market conditions; uncertainties inherent in research and development, including the cost and time required to advance Lucid’s products through regulatory filing; whether regulatory authorities will be satisfied with the design and results of clinical and preclinical studies of Lucid; if and when Lucid’s products are cleared by regulatory authorities; market acceptance of Lucid’s products once approved and commercialized; Lucid’s ability to raise additional funds as needed; and other competitive developments. Additionally, Lucid is monitoring the COVID-19 pandemic and the impact of the pandemic on Lucid’s business. Lucid expects the significance of the COVID-19 pandemic, including the extent of its effects on its financial and operating results, to be dictated by, among other things, the success of efforts to contain the pandemic and the impact of these efforts on Lucid’s business. These factors are difficult or impossible to accurately predict and many of them are beyond Lucid’s control. In addition, new risks and uncertainties may arise from time to time and are difficult to predict. For a more detailed listing and description of these and other material risks and uncertainties that could affect Lucid’s future operations, see Lucid’s Registration Statement No. 333-259721 filed with the Securities and Exchange Commission. Lucid disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions or circumstances on which such expectations may be based, or which may affect the likelihood that actual results different. of those contained in the forward-looking statements.

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