Latest news with #CareDx
Yahoo
5 days ago
- Business
- Yahoo
CareDx Announces Appointment of Nathan Smith as Chief Financial Officer
BRISBANE, Calif., August 06, 2025--(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, today announced the appointment of Nathan Smith to the role of Chief Financial Officer. Nathan will lead key financial and accounting initiatives that are a part of the Company's long-term strategic growth plan. Nathan brings more than 14 years of experience in the molecular diagnostics industry, including senior finance leadership roles at Myriad Genetics and recent CFO positions at Blackrock Neurotech and WIN Brands. "Nathan's deep financial expertise in molecular diagnostics is a great fit for CareDx," said John Hanna, CEO of CareDx. "His track record of operational excellence and experience in supporting diagnostics companies to scale efficiently will be invaluable as we enter our next phase." In conjunction with this appointment, the Company also announced that Abhishek Jain will be retiring from his role as Chief Financial Officer. Abhishek will continue to support CareDx in a consulting capacity to ensure a seamless transition. "On behalf of the Board and the entire CareDx team, I want to express my sincere gratitude to Abhishek for his outstanding leadership as CFO," said John Hanna. "Abhishek's disciplined financial management, stewardship through our CEO transition, and dedication to strengthening our finance function have positioned CareDx for continued success. We wish him all the best." About CareDx CareDx, Inc., headquartered in Brisbane, California, is a precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. For more information, visit Forward Looking Statements This press release includes forward-looking statements related to CareDx, Inc. 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 risks and uncertainties that could cause actual results to differ materially from those projected, including general economic and market factors and other risks discussed in CareDx's filings with 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. View source version on Contacts CareDx Media Contacts Natasha Moshirian Wagnernwagner@ Investor RelationsCaroline Cornerinvestor@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
5 days ago
- Business
- Business Wire
CareDx Announces Appointment of Nathan Smith as Chief Financial Officer
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, today announced the appointment of Nathan Smith to the role of Chief Financial Officer. Nathan will lead key financial and accounting initiatives that are a part of the Company's long-term strategic growth plan. Nathan brings more than 14 years of experience in the molecular diagnostics industry, including senior finance leadership roles at Myriad Genetics and recent CFO positions at Blackrock Neurotech and WIN Brands. 'Nathan's deep financial expertise in molecular diagnostics is a great fit for CareDx,' said John Hanna, CEO of CareDx. 'His track record of operational excellence and experience in supporting diagnostics companies to scale efficiently will be invaluable as we enter our next phase.' In conjunction with this appointment, the Company also announced that Abhishek Jain will be retiring from his role as Chief Financial Officer. Abhishek will continue to support CareDx in a consulting capacity to ensure a seamless transition. 'On behalf of the Board and the entire CareDx team, I want to express my sincere gratitude to Abhishek for his outstanding leadership as CFO,' said John Hanna. 'Abhishek's disciplined financial management, stewardship through our CEO transition, and dedication to strengthening our finance function have positioned CareDx for continued success. We wish him all the best.' About CareDx CareDx, Inc., headquartered in Brisbane, California, is a precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. For more information, visit Forward Looking Statements This press release includes forward-looking statements related to CareDx, Inc. 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 risks and uncertainties that could cause actual results to differ materially from those projected, including general economic and market factors and other risks discussed in CareDx's filings with 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.
Business Wire
5 days ago
- Business
- Business Wire
CareDx Announces Second Quarter 2025 Financial Results
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, today reported financial results for the second quarter ended June 30, 2025. Second Quarter 2025 Financial Highlights Reported revenue of $86.7 million including a $3.8 million write-off of aged receivables associated with tests performed in prior periods Adjusted revenue of $90.5 million, an increase of 14% year-over-year GAAP testing services revenue of $62.0 million, a decrease of 13% year-over-year Adjusted testing services revenue of $65.9 million, an increase of 14% year-over-year Testing services volume of 49,500, an increase of 13% year-over-year GAAP net loss of $8.6 million, compared to a GAAP net loss of $4.6 million in the second quarter of 2024 Non-GAAP net income of $5.6 million, compared to $13.6 million in the second quarter of 2024 Adjusted EBITDA gain of $9.1 million, excluding a $3.8 million write-off of aged receivables, compared to a loss of $0.3 million in the second quarter of 2024, excluding revenue from tests performed in prior periods Cash, cash equivalents and marketable securities of $186 million as of June 30, 2025, net of a $50 million share repurchase carried out during the quarter; no debt as of June 30, 2025 Narrowed full-year 2025 revenue guidance to $367 million to $373 million Recent Business Highlights Eighth consecutive quarter of sequential growth in testing services volumes First Kidney Allograft Outcomes AlloSure Registry ('KOAR') manuscript published in The American Journal of Transplantation Draft LCD affirms surveillance testing coverage for solid organ transplant rejection; The Company intends to comment on aspects of the draft LCD during the open comment period, which ends August 31, 2025 Launched Increasing Organ Transplant Access ("IOTA") tool in XynQAPI® to help transplant centers track performance under CMS's IOTA model ahead of July 1, 2025, activation date Leading presence with 40 abstracts and 12 oral presentations at 2025 World Transplant Congress in San Francisco, CA Launched AlloSure® Plus (formerly AlloView®), an AI-driven diagnostic platform that combines AlloSure® donor-derived cell-free DNA (dd-cfDNA) analysis with established clinical methods to improve prediction of rejection Successfully installed EPIC environment at CareDx and initiated multiple customer pilots in the third quarter 'CareDx had a strong second quarter. Volume growth accelerated, led by AlloSure kidney testing which was up nearly 20% year-over-year. Our cash collections also improved considerably, and coupled with financial discipline, contributed to a substantial adjusted EBITDA improvement,' said John W. Hanna, CareDx President and CEO. 'We had an exceptional showing at the World Transplant Congress where data supporting the use of AlloSure Kidney was highlighted in large, prospective, multi-center studies as being the most significant biomarker for detecting organ rejection. Our evidence and differentiated products, including the launch of AlloSure Plus, are setting us apart as the leader in transplant care.' Q2 2025 Financial Results Total revenue was $86.7 million compared to $92.3 million in the second quarter of 2024, down 6%. Adjusted revenue was $90.5 million, up 14% compared to $79.1 million in the second quarter of 2024, excluding a negative $3.8 million adjustment and a positive $13.2 million adjustment, respectively, related to revenue from tests performed in prior periods. Testing services revenue was $62.0 million, compared to $70.9 million in the second quarter of 2024, a decrease of 13%. Adjusted testing services revenue was $65.9 million, up 14% compared to adjusted testing services revenue of $57.7 million in the second quarter of 2024, excluding a negative $3.8 million adjustment and a positive $13.2 million adjustment, respectively, related to revenue from tests performed in prior periods. Patient and Digital Solutions revenue was $12.8 million, an increase of 19% compared to $10.7 million in the second quarter of 2024. Product revenue was $11.8 million, an increase of 12% compared to $10.6 million in the second quarter of 2024. GAAP net loss was $8.6 million compared to $4.6 million in the second quarter 2024. Basic and diluted GAAP net loss per share was $0.16 compared to $0.09 in the second quarter of 2024. Non-GAAP net income was $5.6 million compared to $13.6 million in the second quarter of 2024. Diluted non-GAAP net income per share was $0.10 compared to $0.25 in the second quarter of 2024. Adjusted EBITDA gain was $9.1 million compared to an adjusted EBITDA loss of ($0.3) million in the second quarter of 2024, excluding a negative $3.8 million adjustment and a positive $13.2 million adjustment, respectively, related to revenue from tests performed in prior periods. 2025 Guidance For the full year 2025, CareDx now expects revenue to be in the range of $367 million to $373 million, compared to the $365 million to $375 million range that was previously disclosed. The Company continues to expect full year 2025 adjusted EBITDA to be in the range of $29 million to $33 million. 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 Statements This press release includes forward-looking statements, including expectations regarding the achievement of CareDx's financial and operational goals and its expectations and prospects for 2025. 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, 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. Use of Non-GAAP Financial Measures CareDx has presented in this release certain financial information in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and also on a non-GAAP basis, including non-GAAP adjusted testing services revenue, non-GAAP adjusted revenue, non-GAAP cost of testing services, non-GAAP cost of product, non-GAAP cost of patient and digital solutions, non-GAAP research and development expenses, non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses, non-GAAP other income, net, non-GAAP income tax expense, non-GAAP gross profit, non-GAAP gross margin (%), non-GAAP operating expenses, non-GAAP income tax expense, non-GAAP net income (loss), non-GAAP basic and diluted net income (loss) per share and adjusted EBITDA. These non-GAAP financial measures are not meant to be considered superior to or a substitute for financial measures calculated in accordance with GAAP, and investors are cautioned that there are material limitations associated with the use of non-GAAP financial measures as an analytical tool. We define non-GAAP net income (loss) and per share results as the GAAP net loss and per share results excluding the impacts of stock-based compensation expense; acquisition-related amortization of purchased intangible assets and related tax effects; costs involved with completing an acquisition; changes in estimated fair value of contingent consideration; litigation settlement expense; transformational initiative costs; and certain other charges presented in the reconciliation in this release. We define adjusted testing services revenue and adjusted revenue as GAAP revenue excluding the impact of revenue from tests performed in prior periods. We define adjusted EBITDA as non-GAAP net income (loss) before interest income, income tax (benefit) expense, depreciation expense and other (income) expense, net and revenue from tests performed in prior periods. We are presenting these non-GAAP financial measures to assist investors in assessing our operating results through the eyes of management and because we believe that these measures provide an additional tool for investors to use in comparing our core business operating results over multiple periods where certain items may vary independent of business performance. Management believes this non-GAAP information is useful for investors, when considered in conjunction with CareDx's GAAP financial statements, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of CareDx's operating results as reported under GAAP. These non-GAAP financial measures should not be considered in isolation from, or as a substitute for, financial information prepared in accordance with GAAP. These non-GAAP financial measures are not necessarily comparable to similarly titled measures presented by other companies. A reconciliation between GAAP and non-GAAP financial information is provided immediately following the financial tables. A reconciliation of the forecasted range for adjusted EBITDA for 2025 is not included in this release due to the number of variables in the projected range and because we are currently unable to quantify accurately certain amounts that would be required to be included in the U.S. GAAP measure or the individual adjustments for such reconciliation. CareDx, Inc. Condensed Consolidated Balance Sheets (Unaudited) (In thousands) December 31, 2024 Assets Current assets: Cash and cash equivalents $68,212 $114,689 Marketable securities 118,043 145,964 Accounts receivable 67,362 64,605 Inventory 27,915 19,503 Prepaid and other current assets 25,764 7,071 Total current assets 307,296 351,832 Property and equipment, net 31,934 33,552 Operating leases right-of-use assets 25,372 24,340 Intangible assets, net 36,037 38,184 Goodwill 40,336 40,336 Restricted cash 551 585 Other assets 2,731 2,221 Total assets $444,257 $491,050 Liabilities and stockholders' equity Current liabilities: Accounts payable $9,863 $7,686 Accrued compensation 19,056 38,333 Accrued litigation settlement expense 20,250 — Accrued and other liabilities 44,011 43,352 Total current liabilities 93,180 89,371 Deferred tax liability 131 164 Contingent consideration 160 174 Operating lease liability, less current portion 22,780 22,263 Other liabilities 636 645 Total liabilities 116,887 112,617 Commitments and contingencies Stockholders' equity: Common stock 53 51 Additional paid-in capital 1,028,591 1,013,193 Accumulated other comprehensive loss (6,113) (8,569) Accumulated deficit (695,161) (626,242) Total stockholders' equity 327,370 378,433 Total liabilities and stockholders' equity $444,257 $491,050 Expand CareDx, Inc. Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited) (In thousands) Three Months Ended June 30, 2025 2024 Cost of testing services reconciliation: GAAP cost of testing services $15,406 $14,308 Stock-based compensation expense (329) (357) Acquisition related-amortization of purchased intangibles (346) (329) Non-GAAP cost of testing services $14,731 $13,622 Cost of product reconciliation: GAAP cost of product $4,981 $6,298 Stock-based compensation expense (108) (225) Acquisition related-amortization of purchased intangibles (442) (411) Restructuring costs (164) (53) Non-GAAP cost of product $4,267 $5,609 Cost of patient and digital solutions reconciliation: GAAP cost of patient and digital solutions $8,271 $7,393 Stock-based compensation expense (189) (350) Acquisition related-amortization of purchased intangibles (153) (238) Restructuring costs (174) — Non-GAAP cost of patient and digital solutions $7,755 $6,805 Research and development expenses reconciliation: GAAP research and development expenses $16,830 $19,693 Stock-based compensation expense (1,407) (1,628) Restructuring costs — (15) Non-GAAP research and development expenses $15,423 $18,050 Sales and marketing expenses reconciliation: GAAP sales and marketing expenses $24,279 $21,002 Stock-based compensation expense (2,146) (2,927) Acquisition related-amortization of purchased intangibles (648) (628) Restructuring costs 12 — Non-GAAP sales and marketing expenses $21,497 $17,447 General and administrative expenses reconciliation: GAAP general and administrative expenses $28,033 $30,907 Stock-based compensation expense (5,245) (10,912) Change in estimated fair value of contingent consideration (501) (210) Acquisition related fees and expenses (204) (5) Litigation settlement expense (350) — Restructuring costs (34) — Transformational initiative costs* (1,871) — Other (charges) income — (44) Non-GAAP general and administrative expenses $19,828 $19,736 Total other income reconciliation: GAAP other income $2,436 $2,726 Non-GAAP other income $2,436 $2,726 Income tax benefit (expense) reconciliation: GAAP income tax benefit (expense) $117 $(22) Tax effect related to amortization of purchased intangibles (109) (98) Non-GAAP income tax benefit (expense) $8 $(120) * Transformational initiative costs consist of consulting expenses which relate to our ongoing transformation strategy that we have undertaken as a series of initiatives focused on operational excellence, enterprise-wide efficiency, and long-term strategic growth. Expand CareDx, Inc. Reconciliation of GAAP to Non-GAAP Gross Profit and Gross Margin (Unaudited) (In thousands, except percentages) Three Months Ended June 30, 2025 2024 GAAP total revenue $86,679 $92,274 GAAP cost of sales 28,658 27,999 GAAP gross profit 58,021 64,275 GAAP gross margin % 67% 70% Stock-based compensation expense 626 932 Restructuring costs 338 53 Acquisition related-amortization of purchased intangibles 941 978 Non-GAAP gross profit $59,926 $66,238 Non-GAAP gross margin % 69% 72% Expand CareDx, Inc. Reconciliation of GAAP Revenue to Non-GAAP Adjusted Revenue (Unaudited) (In thousands) Three Months Ended June 30, 2025 2024 Adjusted revenue reconciliation: Revenue (GAAP) $86,679 $92,274 Revenue from tests performed in prior periods* 3,827 (13,214) Adjusted revenue (Non-GAAP) $90,506 $79,060 * For the three months ended June 30, 2025, the Company reduced revenue by $3.8 million for tests performed in prior periods. For the three months ended June 30, 2024, the Company recognized $13.2 million in revenue for the tests performed in prior periods. Expand CareDx, Inc. Reconciliation of GAAP Testing Services Revenue to Non-GAAP Adjusted Testing Services Revenue (Unaudited) (In thousands) Three Months Ended June 30, 2025 2024 Adjusted testing services revenue reconciliation: Testing services revenue (GAAP) $62,033 $70,918 Revenue from tests performed in prior periods* 3,827 (13,214) Adjusted testing services revenue (Non-GAAP) $65,860 $57,704 * For the three months ended June 30, 2025, the Company reduced revenue by $3.8 million for tests performed in prior periods. For the three months ended June 30, 2024, the Company recognized $13.2 million in revenue for the tests performed in prior periods. Expand CareDx, Inc. Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited) (In thousands, except share and per share data) Three Months Ended June 30, 2025 2024 GAAP net loss $(8,568) $(4,623) Stock-based compensation expense 9,424 16,399 Acquisition related-amortization of purchased intangibles 1,589 1,606 Acquisition related fees and expenses 204 5 Change in estimated fair value of contingent consideration 501 210 Other income and charges — 44 Tax effect related to amortization of purchased intangibles (109) (98) Transformational initiative costs* 1,871 — Restructuring costs 360 68 Litigation settlement expense 350 — Non-GAAP net income $5,622 $13,611 GAAP basic and diluted net loss per share $(0.16) $(0.09) Non-GAAP basic net income per share $0.10 $0.26 Non-GAAP diluted net income per share $0.10 $0.25 54,304,754 52,195,620 56,385,713 54,333,731 * Transformational initiative costs consist of consulting expenses which relate to our ongoing transformation strategy that we have undertaken as a series of initiatives focused on operational excellence, enterprise-wide efficiency, and long-term strategic growth. Expand CareDx, Inc. Reconciliation of Non-GAAP to Adjusted EBITDA (Unaudited) (In thousands) Three Months Ended June 30, 2025 2024 GAAP net loss $(8,568) $(4,623) Stock-based compensation expense 9,424 16,399 Acquisition related-amortization of purchased intangibles 1,589 1,606 Acquisition related fees and expenses 204 5 Change in estimated fair value of contingent consideration 501 210 Other income and charges — 44 Tax effect related to amortization of purchased intangibles (109) (98) Transformational initiative costs 1,871 — Restructuring costs 360 68 Litigation settlement expense 350 — Non-GAAP net income 5,622 13,611 Interest income (2,364) (2,826) Income tax (benefit) expense (8) 121 Depreciation expense 2,132 1,937 Other (income) expense, net (72) 100 Adjusted EBITDA 5,310 12,943 Revenue from tests performed in prior periods 3,827 (13,214) Adjusted EBITDA after revenue from tests performed in prior periods $9,137 $(271) Expand
Yahoo
5 days ago
- Health
- Yahoo
CareDx Announces Landmark KOAR Study Published in the American Journal of Transplantation
KOAR, the Largest Prospective Study of Its Kind, Demonstrates Clinical Utility of AlloSure® in Kidney Transplant Surveillance AlloSure Kidney dd-cfDNA Elevation Strongly Predicts Rejection and Improves Biopsy Yield BRISBANE, Calif., August 06, 2025--(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, today announced the publication of the Kidney Allograft Outcomes AlloSure Registry (KOAR) study in the American Journal of Transplantation. The landmark prospective study demonstrates the clinical utility of AlloSure® donor-derived cell-free DNA (dd-cfDNA) in improving rejection detection and guiding biopsy decisions in kidney transplant recipients. The KOAR study enrolled 1,743 patients across 56 U.S. transplant centers to evaluate the clinical utility of a dd-cfDNA surveillance protocol based on the DART study, which prescribed seven tests in year one and four annually in years two and three. A total of 18,584 AlloSure tests were obtained from the overall cohort. "The scale and clarity of KOAR make it a landmark," said Daniel C. Brennan, MD, Professor of Medicine at Johns Hopkins, author of the publication, and the senior author of the primary DART publication. "In fact, it shows that dd-cfDNA should be considered the first-line test even before DSA. It's arguably the most powerful biomarker we have in kidney transplantation today." "KOAR confirms that dd-cfDNA is a clinically actionable tool that enhances how we detect and manage rejection," said Jonathan S. Bromberg, MD, PhD, Professor of Surgery at the University of Maryland, lead author of the publication, and a key author on the DART publications. "Importantly, it helps clinicians tailor care based on risk." Key findings include: Elevated AlloSure was associated with a 6-fold increase in rejection yield in surveillance biopsies (39% vs. 7%, p<0.001) and a 4-fold increase in for-cause biopsies (47% vs. 12%, p<0.001). AlloSure elevations were detectable up to four months before ABMR and one month before TCMR, supporting its role in early detection and longitudinal monitoring. In post-biopsy monitoring, AlloSure levels declined significantly following treatment, while serum creatinine remained unchanged, reinforcing AlloSure's role in assessing treatment response. The study also demonstrated that dd-cfDNA levels correlate with rejection severity, with higher levels associated with ABMR and mixed rejection, and lower levels linked to borderline or TCMR 1A. This stratification capability positions AlloSure as a critical tool for tailoring immunosuppression and biopsy decisions based on individual patient risk. "The KOAR study provides compelling evidence that dd-cfDNA can optimize biopsy utilization and improve clinical decision-making in kidney transplant care," said Robert Woodward, Chief Scientific Officer of CareDx. "AlloSure empowers physicians to detect rejection earlier and intervene more precisely, to achieve the ultimate goal of improving long-term graft survival." The full publication is available online at: About CareDx CareDx, Inc., headquartered in Brisbane, California, is a precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. For more information, visit Forward Looking Statements This press release includes forward-looking statements related to CareDx, Inc., including statements regarding the potential benefits and results that may be achieved with AlloSure Kidney. 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 risks and uncertainties that could cause actual results to differ materially from those projected, including risks that CareDx does not realize the expected benefits of AlloSure Kidney; risks that the findings in the KAOR study supporting the data may be inaccurate, general economic and market factors; risks that the findings in the studies supporting the data may be inaccurate, general economic and market factors, and other risks 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, 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. View source version on Contacts CareDx Media Contacts Natasha Moshirian Wagnernwagner@ Investor RelationsCaroline Cornerinvestor@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
5 days ago
- Health
- Business Wire
CareDx Announces Landmark KOAR Study Published in the American Journal of Transplantation
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, today announced the publication of the Kidney Allograft Outcomes AlloSure Registry (KOAR) study in the American Journal of Transplantation. The landmark prospective study demonstrates the clinical utility of AlloSure® donor-derived cell-free DNA (dd-cfDNA) in improving rejection detection and guiding biopsy decisions in kidney transplant recipients. The KOAR study enrolled 1,743 patients across 56 U.S. transplant centers to evaluate the clinical utility of a dd-cfDNA surveillance protocol based on the DART study, which prescribed seven tests in year one and four annually in years two and three. A total of 18,584 AlloSure tests were obtained from the overall cohort. 'The scale and clarity of KOAR make it a landmark,' said Daniel C. Brennan, MD, Professor of Medicine at Johns Hopkins, author of the publication, and the senior author of the primary DART publication. 'In fact, it shows that dd-cfDNA should be considered the first-line test even before DSA. It's arguably the most powerful biomarker we have in kidney transplantation today.' 'KOAR confirms that dd-cfDNA is a clinically actionable tool that enhances how we detect and manage rejection,' said Jonathan S. Bromberg, MD, PhD, Professor of Surgery at the University of Maryland, lead author of the publication, and a key author on the DART publications. 'Importantly, it helps clinicians tailor care based on risk.' Key findings include: Elevated AlloSure was associated with a 6-fold increase in rejection yield in surveillance biopsies (39% vs. 7%, p<0.001) and a 4-fold increase in for-cause biopsies (47% vs. 12%, p<0.001). AlloSure elevations were detectable up to four months before ABMR and one month before TCMR, supporting its role in early detection and longitudinal monitoring. In post-biopsy monitoring, AlloSure levels declined significantly following treatment, while serum creatinine remained unchanged, reinforcing AlloSure's role in assessing treatment response. The study also demonstrated that dd-cfDNA levels correlate with rejection severity, with higher levels associated with ABMR and mixed rejection, and lower levels linked to borderline or TCMR 1A. This stratification capability positions AlloSure as a critical tool for tailoring immunosuppression and biopsy decisions based on individual patient risk. 'The KOAR study provides compelling evidence that dd-cfDNA can optimize biopsy utilization and improve clinical decision-making in kidney transplant care,' said Robert Woodward, Chief Scientific Officer of CareDx. 'AlloSure empowers physicians to detect rejection earlier and intervene more precisely, to achieve the ultimate goal of improving long-term graft survival.' The full publication is available online at: About CareDx CareDx, Inc., headquartered in Brisbane, California, is a precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. For more information, visit Forward Looking Statements This press release includes forward-looking statements related to CareDx, Inc., including statements regarding the potential benefits and results that may be achieved with AlloSure Kidney. 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 risks and uncertainties that could cause actual results to differ materially from those projected, including risks that CareDx does not realize the expected benefits of AlloSure Kidney; risks that the findings in the KAOR study supporting the data may be inaccurate, general economic and market factors; risks that the findings in the studies supporting the data may be inaccurate, general economic and market factors, and other risks 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, 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.
