Lucid Diagnostics Receives Notice of Allowance for Key Patent Underlying Its EsoGuard Esophageal DNA Test
Lucid Diagnostics Inc. (Nasdaq: LUCD) has received a Notice of Allowance from the USPTO for a patent application covering its proprietary method of using methylation of the cyclin-A1 (CCNA1) gene to detect esophageal precancer and cancer. This patent strengthens Lucid's intellectual property portfolio and protects a key component of its EsoGuard® Esophageal DNA Test.
EsoGuard uses next-generation sequencing to assess DNA methylation at 31 sites on two genes, vimentin (VIM) and CCNA1. The association of CCNA1 methylation with esophageal neoplasia is novel and appears to be more specific than VIM methylation. The technology behind EsoGuard and the EsoCheck® Esophageal Cell Collection Device was developed at Case Western Reserve University, with Lucid holding the exclusive worldwide license to commercialize it.
Lucid Diagnostics Inc. (Nasdaq: LUCD) ha ricevuto un Avviso di Concessione dall'USPTO per una domanda di brevetto che copre il suo metodo proprietario utilizzando la metilazione del gene cyclin-A1 (CCNA1) per rilevare precancerosi e cancro esofageo. Questo brevetto rafforza il portafoglio di proprietà intellettuale di Lucid e protegge un componente chiave del suo EsoGuard® Esophageal DNA Test.
EsoGuard utilizza il sequenziamento di nuova generazione per valutare la metilazione del DNA in 31 siti su due geni, vimentina (VIM) e CCNA1. L'associazione della metilazione di CCNA1 con neoplasie esofagee è innovativa e sembra essere più specifica rispetto alla metilazione di VIM. La tecnologia alla base di EsoGuard e del dispositivo di raccolta cellulare esofagea EsoCheck® è stata sviluppata alla Case Western Reserve University, con Lucid che detiene la licenza esclusiva a livello mondiale per commercializzarla.
Lucid Diagnostics Inc. (Nasdaq: LUCD) ha recibido un Aviso de Concesión de la USPTO para una solicitud de patente que cubre su método propietario de utilizar la metilación del gen cyclin-A1 (CCNA1) para detectar lesiones precoces y cáncer esofágico. Esta patente refuerza la cartera de propiedad intelectual de Lucid y protege un componente clave de su EsoGuard® Esophageal DNA Test.
EsoGuard utiliza secuenciación de nueva generación para evaluar la metilación del ADN en 31 sitios de dos genes, vimentina (VIM) y CCNA1. La asociación de la metilación de CCNA1 con neoplasias esofágicas es novedosa y parece ser más específica que la metilación de VIM. La tecnología detrás de EsoGuard y del dispositivo de recolección celular esofágica EsoCheck® fue desarrollada en la Case Western Reserve University, con Lucid manteniendo la licencia exclusiva mundial para comercializarla.
Lucid Diagnostics Inc. (Nasdaq: LUCD)는 CCNA1(CCNA1) 유전자의 메틸화를 사용하여 식도 전암 및 암을 검출하는 독점 방법에 대한 특허 출원에 대해 USPTO로부터 허가 통지를 받았습니다. 이 특허는 Lucid의 지적 재산 포트폴리오를 강화하고 EsoGuard® Esophageal DNA Test의 핵심 구성 요소를 보호합니다.
EsoGuard는 차세대 시퀀싱을 사용하여 두 개의 유전자, 비멘틴 (VIM) 및 CCNA1에서 31개 지점의 DNA 메틸화를 평가합니다. CCNA1 메틸화와 식도 신생물과의 연관성은 새롭고 VIM 메틸화보다 더 특이적인 것으로 보입니다. EsoGuard와 EsoCheck® 식도 세포 수집 장치의 기술은 Case Western Reserve University에서 개발되었으며, Lucid는 이를 상용화할 수 있는 전 세계적으로 독점적인 라이센스를 보유하고 있습니다.
Lucid Diagnostics Inc. (Nasdaq: LUCD) a reçu un Avis de Concession de l'USPTO pour une demande de brevet couvrant sa méthode propriétaire utilisant la méthylation du gène cyclin-A1 (CCNA1) pour détecter le précancer et le cancer œsophagien. Ce brevet renforce le portefeuille de propriété intellectuelle de Lucid et protège un composant clé de son EsoGuard® Esophageal DNA Test.
EsoGuard utilise le séquençage de nouvelle génération pour évaluer la méthylation de l'ADN à 31 sites sur deux gènes, la vimentine (VIM) et le CCNA1. L'association de la méthylation de CCNA1 avec les néoplasies œsophagiennes est nouvelle et semble être plus spécifique que la méthylation de VIM. La technologie derrière EsoGuard et le dispositif de collecte cellulaire œsophagien EsoCheck® a été développée à la Case Western Reserve University, Lucid détenant la licence exclusive mondiale pour la commercialiser.
Lucid Diagnostics Inc. (Nasdaq: LUCD) hat eine Mitteilung über die Erlaubnis vom USPTO für einen Patentantrag erhalten, der sein proprietäres Verfahren zur Verwendung der Methylierung des Cyclin-A1-Gens (CCNA1) zur Erkennung von esophagealem Präkanzerom und Krebs abdeckt. Dieses Patent stärkt Lucids Portfolio an geistigem Eigentum und schützt einen Schlüsselbestandteil seines EsoGuard® Esophageal DNA Test.
EsoGuard nutzt Next-Generation-Sequencing, um die DNA-Methylierung an 31 Stellen zweier Gene, Vimentin (VIM) und CCNA1, zu bewerten. Die Assoziation der CCNA1-Methylierung mit esophagealen Neoplasien ist neuartig und scheint spezifischer zu sein als die VIM-Methylierung. Die Technologie hinter EsoGuard und dem EsoCheck® Esophageal Cell Collection Device wurde an der Case Western Reserve University entwickelt, wobei Lucid die exklusive weltweite Lizenz zur Vermarktung hält.
- Received Notice of Allowance for key patent application
- Patent strengthens intellectual property portfolio
- Provides protection for CCNA1 methylation assay method
- Novel association of CCNA1 methylation with esophageal neoplasia
- Exclusive worldwide license to commercialize the technology
- None.
Insights
This patent allowance significantly strengthens Lucid Diagnostics' intellectual property position for its EsoGuard Esophageal DNA Test. The patent covers a key component of the test - the method of using CCNA1 gene methylation to detect esophageal precancer and cancer. This is a critical development for several reasons:
- It provides strong protection for Lucid's proprietary technology, potentially creating barriers to entry for competitors.
- The CCNA1 methylation appears to be more specific for esophageal neoplasia than previously known markers, which could enhance the test's accuracy and clinical utility.
- It validates Lucid's strategy of focusing on laboratory methods, which may lead to additional patent protections for other assay components.
While this news strengthens Lucid's competitive position, it's important to note that the company is still in the commercial stage with a relatively small market cap of
From a financial perspective, this patent allowance is a positive development for Lucid Diagnostics, but its immediate impact on the company's financials may be Here's why:
- Intellectual property (IP) is a crucial asset for biotech companies, potentially increasing the company's valuation and attractiveness to investors or potential acquirers.
- However, the revenue impact will depend on successful commercialization of the EsoGuard test, which may take time and require significant marketing efforts and clinical adoption.
- The patent could provide a competitive advantage, potentially leading to higher market share and pricing power in the long run.
- It may also reduce legal risks and potential future litigation costs related to IP disputes.
Investors should monitor key metrics like test volume growth, reimbursement progress and revenue trends in upcoming quarters to gauge the commercial traction of EsoGuard. While promising, this news alone may not significantly alter the company's near-term financial outlook given its early commercial stage and current market cap of
Patent covers proprietary method using methylation of the CCNA1 gene to help detect esophageal precancer and cancer
"This patent strengthens the already robust intellectual property portfolio underlying our groundbreaking technologies and will provide strong protection for the CCNA1 methylation assay method which is at the heart of the EsoGuard assay," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "The allowance validates our strategy of focusing on the laboratory methods of our assay—a strategy we will continue to aggressively pursue for other components of the assay."
EsoGuard utilizes next-generation sequencing (NGS) to assess DNA methylation at 31 sites on two genes, vimentin (VIM) and cyclin-A1 (CCNA1). Such methylation has been shown to be strongly associated with conditions along the spectrum from early esophageal precancer (non-dysplastic Barrett's Esophagus or BE), to late precancer (dysplastic BE), to cancer (esophageal adenocarcinoma). Although VIM methylation had been previously associated with gastrointestinal neoplasias, the association of CCNA1 methylation with esophageal neoplasia is novel and appears to be more specific.
The technology behind EsoGuard and the EsoCheck® Esophageal Cell Collection Device was developed at Case Western Reserve University (CWRU) by faculty members Sanford Markowitz, M.D., PhD, Amitabh Chak, M.D., and Joseph Willis, M.D., with the support of research funds from the National Institutes of Health (NIH) and elsewhere. Lucid holds the exclusive worldwide license to commercialize this technology. The successful transfer of the assay from the academic research laboratory and its subsequent commercialization was the result of close, ongoing collaboration between Lucid and CWRU.
About Lucid Diagnostics
Lucid Diagnostics Inc. is a commercial-stage, cancer prevention medical diagnostics company and subsidiary of PAVmed Inc. (Nasdaq: PAVM). Lucid is focused on the millions of patients with gastroesophageal reflux disease (GERD), also known as chronic heartburn, who are at risk of developing esophageal precancer and cancer. Lucid's EsoGuard® Esophageal DNA Test, performed on samples collected in a brief, noninvasive office procedure with its EsoCheck® Esophageal Cell Collection Device, represent the first and only commercially available tools designed with the goal of preventing cancer and cancer deaths through widespread, early detection of esophageal precancer in at-risk patients.
For more information about Lucid, please visit www.luciddx.com and for more information about its parent company PAVmed, please visit www.pavmed.com.
Forward-Looking Statements
This press release includes forward-looking statements that involve risk and uncertainties. Forward-looking statements are any statements that are not historical facts. Such forward-looking statements, which are based upon 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. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of Lucid's common stock; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required to advance Lucid's products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from Lucid's clinical and preclinical studies; whether and when Lucid's products are cleared by regulatory authorities; market acceptance of Lucid's products once cleared and commercialized; Lucid's ability to raise additional funding as needed; and other competitive developments. In addition, Lucid continues to monitor the COVID-19 pandemic and the pandemic's impact on Lucid's businesses. These factors are difficult or impossible to predict accurately 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 further list and description of these and other important risks and uncertainties that may affect Lucid's future operations, see Part I, Item 1A, "Risk Factors," in Lucid's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, "Risk Factors" in any Quarterly Report on Form 10-Q filed by Lucid Diagnostics after its most recent Annual Report. 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 those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.
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SOURCE Lucid Diagnostics
FAQ
What patent did Lucid Diagnostics (LUCD) receive a Notice of Allowance for?
How does the EsoGuard Esophageal DNA Test work?
What is the significance of CCNA1 methylation in Lucid Diagnostics' (LUCD) technology?
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