Lucid Diagnostics Appoints Danielle Scelfo as Senior Vice President, Market Access & Government Affairs
Lucid Diagnostics (Nasdaq: LUCD) has appointed Danielle Scelfo as Senior Vice President of Market Access & Government Affairs. Scelfo, a veteran with over 25 years of experience in healthcare policy and market access, will focus on expanding insurance coverage and patient access for the company's EsoGuard® Esophageal DNA Test.
The appointment comes at a crucial time following a positive MolDX CAC meeting that suggests Medicare coverage is approaching. Scelfo's previous experience includes leadership roles at ClearNote Health, CareDx, Hologic, and other prominent healthcare companies. She will leverage her expertise to strengthen Lucid's market access infrastructure and accelerate commercial coverage expansion.
Lucid Diagnostics (Nasdaq: LUCD) ha nominato Danielle Scelfo come Senior Vice President di Market Access & Government Affairs. Scelfo, con oltre 25 anni di esperienza nel policy sanitario e nell'accesso al mercato, si concentrerà sull'espansione della copertura assicurativa e dell'accesso dei pazienti al test EsoGuard® Esophageal DNA Test.
La nomina arriva in un momento cruciale dopo un positivo incontro MolDX CAC che lascia intravedere una possibile copertura Medicare. L'esperienza pregressa di Scelfo comprende ruoli di leadership in ClearNote Health, CareDx, Hologic e altre note aziende sanitarie. Utilizzerà la sua competenza per rafforzare l'infrastruttura di market access di Lucid e accelerare l'espansione della copertura commerciale.
Lucid Diagnostics (Nasdaq: LUCD) ha designato a Danielle Scelfo como Vicepresidenta Senior de Acceso al Mercado y Asuntos Gubernamentales. Scelfo, una profesional con más de 25 años de experiencia en políticas sanitarias y acceso al mercado, se centrará en ampliar la cobertura de seguros y el acceso de los pacientes al ensayo EsoGuard® Esophageal DNA Test.
Este nombramiento llega en un momento clave tras una positiva reunión MolDX CAC que sugiere que la cobertura por parte de Medicare está cerca. La experiencia previa de Scelfo incluye puestos de liderazgo en ClearNote Health, CareDx, Hologic y otras empresas destacadas del sector. Aprovechará su experiencia para fortalecer la infraestructura de acceso al mercado de Lucid y acelerar la expansión de la cobertura comercial.
Lucid Diagnostics (나스닥: LUCD)가 Danielle Scelfo를 시장 접근 및 정부 관계 부문 수석 부사장으로 임명했습니다. Scelfo는 보건 정책 및 시장 접근 분야에서 25년이 넘는 경력의 베테랑으로, 회사의 EsoGuard® 식도 DNA 검사의 보험 적용 범위 확대와 환자 접근성 강화에 집중할 예정입니다.
이번 임명은 Medicare 보장 확대가 임박했다는 긍정적인 MolDX CAC 회의 이후 중요한 시점에 이뤄졌습니다. Scelfo의 이전 경력으로는 ClearNote Health, CareDx, Hologic 등 주요 헬스케어 기업에서의 선도적 역할이 포함되어 있으며, Lucid의 시장 접근 인프라를 강화하고 상업적 보장 확장을 가속화하는 데 그녀의 전문 지식을 활용할 것입니다.
Lucid Diagnostics (bours. Nasdaq: LUCD) a nommé Danielle Scelfo au poste de Vice-présidente principale, Accès au marché et Affaires gouvernementales. Scelfo, vétéran avec plus de 25 ans d'expérience dans les politiques de santé et l'accès au marché, se concentrera sur l'élargissement de la couverture d'assurance et l'accès des patients au test EsoGuard® Esophageal DNA Test.
Cette nomination intervient à un moment crucial, après une réunion MolDX CAC positive indiquant que la couverture Medicare est en vue. L'expérience antérieure de Scelfo comprend des postes de direction chez ClearNote Health, CareDx, Hologic et d'autres entreprises majeures du secteur. Elle mettra à profit son expertise pour renforcer l'infrastructure d'accès au marché de Lucid et accélérer l'expansion de la couverture commerciale.
Lucid Diagnostics (Nasdaq: LUCD) hat Danielle Scelfo als Senior Vice President für Market Access & Government Affairs ernannt. Scelfo, eine Veteranin mit über 25 Jahren Erfahrung im Gesundheitswesen, Politik und Marktzugang, wird sich darauf konzentrieren, die Versicherungsdeckung zu erweitern und den Patientenzugang zum EsoGuard® Esophageal DNA Test zu verbessern.
Die Ernennung erfolgt zu einem entscheidenden Zeitpunkt nach einem positiven MolDX CAC-Treffen, das darauf hindeutet, dass eine Medicare-Abdeckung näher rückt. Scelfos frühere Erfahrungen umfassen Führungspositionen bei ClearNote Health, CareDx, Hologic und anderen namhaften Gesundheitsunternehmen. Sie wird ihr Fachwissen nutzen, um Lucids Marktzugriffs-Infrastruktur zu stärken und die kommerzielle Abdeckung schneller auszubauen.
Lucid Diagnostics (بورصة ناسداك: LUCD) قد عيّنت دانييل سكلفو كنائب أول لرئيس وصول السوق والشؤون الحكومية. سكلفو، وهي ذات خبرة تزيد على 25 عامًا في سياسات الرعاية الصحية والوصول إلى الأسواق، ستتركز جهودها على توسيع التغطية التأمينية وتحسين وصول المرضى إلى اختبار EsoGuard® Esophageal DNA Test.
يأتي التعيين في وقت حاسم بعد اجتماع MolDX CAC الإيجابي الذي يشير إلى اقتراب تغطية Medicare. تشمل خبرتها السابقة مناصب قيادية في ClearNote Health وCareDx وHologic وشركات صحية بارزة أخرى. ستستفيد من خبرتها لتعزيز بنية وصول Lucid إلى السوق وتسريع توسيع التغطية التجارية.
Lucid Diagnostics（纳斯达克：LUCD） 已任命 Danielle Scelfo 为市场准入与政府事务高级副总裁。Scelfo 是在医疗保健政策和市场准入领域拥有超过 25 年经验 的资深人士，将专注于扩大保险覆盖范围和患者对公司 EsoGuard® 食道DNA检测 的获取。
此次任命时机关键，正值一场积极的 MolDX CAC 会议之后，暗示 Medicare 覆盖将近在眼前。Scelfo 之前的经历包括在 ClearNote Health、CareDx、Hologic 等知名医疗保健公司担任领导职务。她将运用其专业知识，强化 Lucid 的市场准入基础设施并加速商业覆盖的扩张。
- None.
- Current lack of Medicare coverage for EsoGuard test
- Limited commercial insurance coverage requiring expansion
Insights
Lucid's strategic hire of reimbursement veteran Scelfo signals Medicare approval for EsoGuard is likely imminent, potentially transforming commercialization prospects.
This executive appointment carries unusual significance as it comes at a critical inflection point in Lucid's commercialization journey. The company has strategically hired Danielle Scelfo, an industry veteran with over 25 years of specialized experience in diagnostics reimbursement, precisely when Medicare coverage for their EsoGuard test appears to be approaching. The timing is particularly telling - companies typically bolster their market access leadership just before anticipated coverage decisions.
The press release contains several powerful market access indicators. Most notably, the reference to an "extremely positive MolDX CAC meeting" suggests Lucid has successfully navigated a crucial step in the Medicare coverage determination process. The Medicare Administrative Contractor (MAC) Molecular Diagnostic Services (MolDX) program's Contractor Advisory Committee (CAC) meetings typically precede formal coverage decisions, and positive feedback at this stage substantially increases approval probability.
Scelfo's background is strategically aligned with Lucid's immediate needs. Her experience at companies like ClearNote Health, CareDx, Hologic, and Exact Sciences demonstrates expertise in securing coverage for molecular diagnostic tests - precisely what EsoGuard requires. Her previous roles chairing industry reimbursement workgroups and contributing to CPT code development for the AMA further strengthen Lucid's position when negotiating with Medicare and commercial payers.
The EsoGuard test addresses esophageal precancer detection, a critical clinical need with significant market potential if reimbursement barriers are removed. The strategic hire signals confidence that Lucid's clinical evidence package is sufficient to secure coverage, which would transform the test's commercial viability and accessibility to patients at risk for esophageal cancer.
Scelfo to strengthen and scale Lucid's market access infrastructure ahead of key upcoming reimbursement milestones—including Medicare coverage for EsoGuard—and to accelerate commercial coverage expansion
"Lucid is at an important inflection point as we seek to expand patient access to our groundbreaking EsoGuard test and unlock its substantial commercial opportunity. The recent extremely positive MolDX CAC meeting strengthens our confidence that Medicare coverage is within sight, and that we will be able to accelerate our ongoing positive engagements with commercial insurers on EsoGuard coverage," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "We are very excited to have Danielle join the Lucid team at this critical juncture. She is a widely respected, strategically focused market access professional with a proven track record of building successful teams that have secured broad coverage for molecular diagnostic tests across the industry. Her efforts will be powered by a clinical evidence package that panelists at the CAC meeting confirmed strongly supports EsoGuard's performance and clinical utility in detecting esophageal precancer before it progresses to cancer."
Ms. Scelfo most recently served as Vice President, Market Access & Health Policy at ClearNote Health, a commercial-stage cancer detection company focused on blood-based molecular tests. She previously held various senior market access, reimbursement, and health policy roles in the diagnostics sector, including leadership positions at CareDx, Inc., Hologic, Inc., Adaptive Biotechnologies Corporation, and Genomic Health, Inc. (now part of Exact Sciences, Inc.). Her early career experience included roles at UnitedHealthcare, Johnson & Johnson, and Sanofi S.A., formerly Sanofi-Aventis. She has also held prominent leadership positions in the diagnostics industry, including as Chair of the Coalition for 21st Century Medicine Reimbursement and Policy Workgroup and the California Healthcare Institute Diagnostic Workgroup, and contributed to multiple diagnostic CPT working groups for the American Medical Association.
"I am incredibly excited to join the Lucid team at this pivotal moment as the Company advances toward Medicare coverage and broader commercial insurance coverage of EsoGuard," said Ms. Scelfo. "I look forward to working closely with Lucid leadership to leverage the strong clinical evidence supporting this groundbreaking technology to drive widespread payor coverage, build a best-in-class market access team, and advance policies that secure broad coverage and access for patients."
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
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