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CareDx, Inc. (NASDAQ: CDNA) is at the forefront of transforming transplant patient care through its innovative surveillance management solutions. Dedicated to improving the lives of organ transplant patients, CareDx leverages the latest in genomics and bioinformatics technology combined with rigorous clinical evidence derived from trials and registries.
CareDx offers a suite of precision medicine solutions aimed at enhancing both pre- and post-transplant care. One of its flagship products, AlloSure®, is the first and only non-invasive blood test that directly measures allograft injury. This next-generation sequencing (NGS) based test detects donor-derived cell-free DNA (dd-cfDNA), providing clinicians with a powerful tool to identify organ injury and the probability of active rejection, particularly in kidney transplant patients.
The company's portfolio also includes AlloMap Heart, AlloSure Heart, and AlloSure Lung, which are dd-cfDNA solutions designed for heart and lung transplant recipients. These products underscore CareDx’s commitment to offering clinically differentiated, high-value healthcare solutions that span the entire transplant journey.
CareDx generates the majority of its revenue from the United States, with a significant portion coming from its testing services. Its product suite not only addresses the critical needs of transplant patients but also supports healthcare providers in delivering better patient outcomes through genomics-based information.
Recent achievements include the continued expansion of their product line and partnerships with leading healthcare institutions to further validate and implement their innovative diagnostic solutions. These efforts position CareDx as a leader in the field of transplant diagnostics and surveillance.
CareDx, Inc. (Nasdaq: CDNA) announced that the Centers for Medicare and Medicaid Services (CMS) plans to retire a draft LCD that would have restricted coverage for non-invasive blood-based surveillance testing for allograft rejection. This decision, along with the February 2024 removal of restrictive language in the accompanying Billing Article, effectively restores longstanding coverage for AlloSure®, AlloMap®, and HeartCare®.
The company's President and CEO, John W. Hanna, expressed appreciation for CMS listening to patients and clinicians who advocated for access to these tests. The restored coverage includes surveillance monitoring of organ transplant rejection without requiring ties to invasive biopsies. CareDx has been a proponent for improving access to transplantation innovations and supported efforts to restore Medicare coverage for non-invasive surveillance testing.
CareDx (Nasdaq: CDNA) reported strong Q2 2024 results, with total revenue of $92.3 million, up 31% year-over-year. Testing Services volume grew 17% to 43,700 tests. The company achieved non-GAAP net income of $13.6 million and positive adjusted EBITDA of $12.9 million, a significant improvement from Q2 2023. CareDx generated $18.9 million in cash from operations and ended the quarter with $228.9 million in cash and no debt.
Key highlights include expanded coverage by 27 million lives nationwide and publication of studies validating their HeartCare® and AlloSure® Kidney products. CareDx raised its 2024 guidance, now expecting annual revenue of $320-$328 million and adjusted EBITDA of $9-$15 million. The company's focus on growth and serving transplant patients has driven performance across all business segments.
CareDx (Nasdaq: CDNA), a company focused on innovative healthcare solutions for transplant patients, has announced its plan to release second quarter 2024 financial results on Wednesday, July 31, 2024, after the market closes. The company will host a conference call at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time to discuss the results. Interested parties can join the call by dialing 1-800-267-6316 (domestic) or 1-203-518-9783 (international) and using the Conference ID: CareDx. Additionally, a live webcast will be available on the investor relations section of CareDx's website.
CareDx announced a landmark publication in Nature Medicine validating their AI-enabled risk prediction model, AlloView, and AlloSure Kidney, a donor-derived cell-free DNA (dd-cfDNA) test. The study, conducted by the Paris Institute for Transplantation and Organ Regeneration with U.S. and Belgian researchers, involved 2,882 patients and showed that combining AlloView with AlloSure and standard care measures enhances detection and characterization of kidney allograft rejection. Key findings include AlloSure's ability to detect subclinical rejection and predict biopsy-proven rejection, and AlloView's utility in therapy monitoring. This validation supports the clinical utility of these tools in routine kidney transplant patient monitoring, potentially setting new global standards.
CareDx has announced new data to be presented at the 2024 American Transplant Congress from June 1-5 in Philadelphia. The data will highlight the clinical utility of CareDx's products, including AI integration in kidney transplant monitoring.
AI-derived AlloView results correlate with biopsy-proven kidney rejection, enhancing early rejection risk prediction. AlloSure Kidney’s longitudinal monitoring helps identify graft injury earlier and assesses rejection treatments effectively.
KOAR data show AlloSure-informed biopsies detect more acute rejections compared to traditional methods. AlloSure can potentially reduce unnecessary biopsies in cases of delayed graft function, avoiding up to 36% of biopsies.
Additionally, AlloMap and AlloSure indicate lower cancer risk post-heart transplant. Experts will present these findings at a symposium moderated by Dr. Kiran Khush.
CareDx has reiterated its position that it does not infringe Natera's '544 patent, emphasizing that Natera's injunction motion is irrelevant to its current business operations. The company clarified that it stopped using the previously alleged infringing AlloSure process since August 2023, switching to a new process believed to be non-infringing. The validity of the '544 patent is still under judicial review. CareDx further noted that previous claims by Natera on other patents were dismissed or found non-infringing. The ongoing litigation is not expected to affect CareDx's ability to provide its AlloSure and AlloMap services to transplant patients and clinicians.
CareDx (Nasdaq: CDNA), known as 'The Transplant Company,' has announced its participation in two upcoming investor conferences. The company's management will present at the Jefferies Global Healthcare Conference on June 6, 2023, at 11:30 AM PT / 2:30 PM ET and the Goldman Sachs 45th Annual Global Healthcare Conference on June 11, 2023, at 1:00 PM PT / 4:00 PM ET. These events provide opportunities for CareDx to discuss its precision medicine solutions for transplant patients and caregivers with investors. Interested parties can listen to the webcasts via the Events & Presentations section of the CareDx Investor Relations website.
CareDx announced findings from the SHORE study, which demonstrates that its HeartCare diagnostic tool outperforms donor-derived cell-free DNA (dd-cfDNA) testing alone in identifying acute cellular rejection (ACR) in heart transplant patients.
The study, involving over 2,700 patients across 67 centers, shows that dual-negative HeartCare results correlate with the lowest ACR incidence at 1.5%, while dual-positive results have the highest at 9.2%.
Cardiologists performed the fewest biopsies following dual-negative results (8.8%), significantly lower than dual-positive results (35.4%). The study highlights reduced biopsy rates and excellent clinical outcomes, with a 95% survival rate and 97% normal allograft function at two years post-transplant.
This significant study, published in The Journal of Heart and Lung Transplantation, underscores the benefits of dual molecular testing for heart transplant patient monitoring.
CareDx, Inc. (Nasdaq: CDNA) reported first quarter 2024 revenue of $72.0 million, with Testing Services revenue growing by 15% compared to the previous quarter. The company expanded payer coverage by 14 million lives, presented scientific advancements at ISHLT, and ended the quarter with approximately $216 million in cash and no debt. However, there was a 7% decrease in revenue compared to the first quarter of 2023, with a net loss of $16.7 million in the first quarter of 2024.
CareDx, Inc. (Nasdaq: CDNA) announced the award of 54,350 restricted stock units (RSUs) to 17 new employees as an inducement for employment. The RSUs were granted under the 2019 Inducement Equity Incentive Plan and vest over different periods based on the number of shares awarded.
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