Latest news with #LocalCoverageDetermination
Business Wire
18-07-2025
- Business
- Business Wire
CareDx Announces Proposed Draft LCD That Affirms Surveillance Testing Coverage for Solid Organ Transplant Rejection
BRISBANE, Calif.--(BUSINESS WIRE)--CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ – a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – announced the release of a proposed draft Local Coverage Determination (LCD) related to molecular testing for solid organ allograft rejection. There is no change in current coverage and the draft LCD is open for comment through August 31, 2025. The draft policy would continue to provide coverage for surveillance testing for kidney, heart, and lung transplant patients without a tie to protocol biopsy, underscoring the value of this important non-invasive molecular testing for solid organ transplant patients. In addition, the draft policy introduces a bundled payment concept for surveillance testing. The Company is reviewing the draft coverage and payment policy and anticipates providing additional information during its upcoming earnings call on August 6, 2025. 'We believe publication of this draft policy solidifies coverage for surveillance testing and supports our longstanding position that our tests improve health outcomes for transplant patients,' said John W. Hanna, President and CEO of CareDx. 'We do not expect changes in the use of our testing in response to this draft LCD and remain deeply committed to patient care and providing access to our testing. We look forward to providing feedback on the draft LCD through the public comment process.' The proposed LCD is available at: About CareDx – The Transplant Company™ CareDx, Inc., headquartered in Brisbane, California, is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey and is the leading provider of genomics-based information for transplant patients. For more information, please visit: Forward Looking Statement This press release includes forward-looking statements, including statements regarding the potential benefits and results that may be achieved with AlloSure ®, AlloMap ® and HeartCare ®, the use of our tests, and reimbursement coverage. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, all of which are difficult to predict and many of which are beyond CareDx's control, that could cause the actual results to differ materially from those projected, including general economic and market factors, and global economic and marketplace uncertainties, among others discussed in CareDx's filings with the Securities and Exchange Commission (the 'SEC'), including, but not limited to, the Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed by CareDx with the SEC on February 28, 2025, the Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 filed by CareDx with the SEC on April 30, 2025, and other reports that CareDx has filed with the SEC. Any of these may cause CareDx's actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx's forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
Malaysian Reserve
16-07-2025
- Business
- Malaysian Reserve
MolDX to Convene Expert Medical Panel on Medicare Local Coverage Determination (LCD) for Lucid Diagnostics' EsoGuard® Esophageal DNA Test
Virtual public CAC meeting to be held September 4, 2025, at 2:00 p.m. ET NEW YORK, July 16, 2025 /PRNewswire/ — Lucid Diagnostics Inc. (Nasdaq: LUCD) ('Lucid' or the 'Company'), a commercial-stage, cancer prevention medical diagnostics company and subsidiary of PAVmed Inc. (Nasdaq: PAVM), today announced that on Thursday, September 4, 2025, from 2:00 to 4:00 p.m. ET, MolDX-participating Medicare Administrative Contractors (MACs)—Palmetto GBA, CGS Administrators, Noridian Healthcare Solutions, and WPS Government Health Administrators—will convene a MolDX Contractor Advisory Committee (CAC) Meeting of medical experts as a critical step in the reconsideration of Local Coverage Determination (LCD) L39256, 'MolDX: Molecular Testing for Detection of Upper Gastrointestinal Metaplasia, Dysplasia, Neoplasia,' as requested by Lucid in November 2024 to secure Medicare coverage for its EsoGuard® Esophageal DNA Test. 'We are grateful to the MolDX team for their rigorous evaluation of our clinical evidence package, which has culminated in this CAC meeting where medical experts will contribute deep domain expertise and real-world experience in nonendoscopic esophageal precancer testing,' said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. 'We view this meeting as strong evidence of progress toward a positive Medicare coverage policy outcome. There is broad consensus within the GI community on the clinical utility of EsoGuard for esophageal precancer testing, supported by professional society guidelines, peer-reviewed publications, and real-world experience from nearly 40,000 patients referred for EsoGuard testing to date. With our strengthened balance sheet, we are well equipped to successfully navigate the final stages of this process.' The CAC panel will discuss the clinical literature related to Local Coverage Determination (LCD) L39256, and medical experts will have the opportunity to provide important clinical context for the evidence. Discussions will occur between CAC panelists and Contractor Medical Directors. The public may attend; however, questions from the public will not be entertained. Interested stakeholders may register to listen to the CAC meeting via Microsoft Teams Webinar. Advance registration is required and must be completed by Wednesday, September 3, 2025, at 11:59 p.m. ET. To register, please visit: Register Here. About Lucid DiagnosticsLucid 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 and for more information about its parent company PAVmed, please visit Forward-Looking StatementsThis 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.
Otago Daily Times
03-06-2025
- Business
- Otago Daily Times
Pacific Edge raises $16m in share sale
Pacific Edge has raised $16 million in new equity in a placement of new ordinary shares — $1m more than it sought — after accepting over-subscriptions. On Friday, the cancer diagnostics company announced a $20m capital raise, saying it was about ensuring it had the cash reserves to capitalise on recent clinical and commercial milestones, grow in non-Medicare channels in the United States and regain Medicare coverage of its tests. It comprised a placement of $15m of new ordinary shares offered to selected investors and an offer of $5m of new shares to retail investors, by way of a share-purchase plan. The share issue was priced at $0.10 per share. Yesterday, the company said the placement — which was well-supported by existing shareholders — was completed on Friday and was subject to shareholder approval. It was now targeting the opening of a $5m offer to eligible retail investors at the same per share offer price in July or early August, with the ability to accept oversubscriptions. In a statement to the NZX, chairman Chris Gallaher said the company was delighted with the investor support it had received. The inclusion of Cxbladder in the American Urological Association's (AUA) new microhematuria guideline in February was significant and had allowed the company to view the non-coverage determination differently. "We are leveraging the important AUA guideline to build on the commercial momentum we have already established, including our plans to regain Medicare coverage," he said. Medicare coverage of the company's tests ceased after the Local Coverage Determination (LCD) became effective on April 24. In a note on Pacific Edge's FY25 financial result also released on Friday, Forsyth Barr analysts described it as "relatively uneventful". Revenue was consistent with the firm's expectations and costs were slightly higher than expected. Despite Pacific Edge being adamant for some time it had sufficient cash resources to navigate the LCD uncertainty, the analysts were not surprised by the capital raise. It was the company's 11th equity raise since 2003 — cumulative raises totalled more than $260m — which would take its share count to more than 1billion from just under 10million in 2004. Post-raise, its cash balance would be about $38m ($22.6 million at FY25) and the analysts estimated that was 16 to 18 months of cash on hand. "While this is a supportive lifeline, even in the event of [Medicare] recoverage, we aren't convinced this is the last of PEB's raises," they said. s
