Welcome to our dedicated page for Caredx news (Ticker: CDNA), a resource for investors and traders seeking the latest updates and insights on Caredx stock.
CareDx Inc (CDNA) delivers innovative non-invasive diagnostics for transplant patient care through advanced genomics and bioinformatics. This news hub provides investors and healthcare professionals with essential updates on the company's developments in precision medicine.
Key resources include: Earnings reports detailing financial performance in transplant diagnostics, regulatory updates on FDA-cleared testing solutions, and strategic partnership announcements expanding into hematology oncology. Track clinical trial outcomes validating AlloSure® monitoring and discover operational milestones in digital health integration.
Our curated collection enables efficient tracking of CDNA's progress in reducing invasive biopsies through blood-based dd-cfDNA analysis. Stay informed about innovations in kidney, heart, and lung transplant surveillance technologies that are reshaping organ rejection management.
Bookmark this page for real-time updates on CareDx's evidence-based diagnostic solutions and their impact on transplant care standards. Verify analysis dates and consult official filings for complete context on all developments.
CareDx, Inc. (Nasdaq: CDNA), a precision medicine company focused on transplant healthcare solutions, has announced the closure of a Department of Justice (DOJ) investigation with no finding of wrongdoing. The DOJ has declined to prosecute or take further action, as revealed in a Court document unsealed on October 7, 2024. This decision follows the U.S. Securities and Exchange Commission's (SEC) closure of its investigation in September 2023, also without taking any action against CareDx.
The investigations were related to a qui tam action filed by a former CareDx employee on February 12, 2021, in the federal district court for the Eastern District of New York. CareDx views these outcomes as validation that the allegations were meritless and reinforces confidence in its operational integrity. The company plans to vigorously defend itself if the former employee proceeds with litigation.
CareDx, Inc. (Nasdaq: CDNA), a precision medicine company focused on transplant healthcare solutions, has granted restricted stock units (RSUs) to 14 new employees as an inducement for employment. A total of 44,000 shares of common stock were awarded under the company's 2019 Inducement Equity Incentive Plan, approved under Nasdaq Listing Rule 5635(c)(4).
The RSUs have varying vesting schedules:
- 9,000 shares vest over four years (25% after one year, then annually)
- 14,000 shares vest over four years (25% after one year, then quarterly)
- 18,000 shares vest over three years (33.33% after one year, then quarterly)
- 2,000 shares vest over two years (50% annually)
- 1,000 shares vest over two years (50% after one year, then quarterly)
All grants are subject to continued service through each vesting date.
CareDx (Nasdaq: CDNA) has announced key executive appointments to drive its strategic growth initiatives. Keith Kennedy joins as Chief Operating Officer, bringing over 20 years of healthcare leadership experience. He will lead the company's operational excellence transformation. Jessica Meng becomes Chief Commercial Officer, tasked with driving global commercial growth across CareDx's portfolio. She brings expertise in commercial strategies for pharmaceutical and molecular diagnostics industries.
Additionally, Marica Grskovic, Ph.D., has been appointed Chief Strategy Officer to lead strategic planning and corporate development. These appointments come as CareDx prepares to share its long-term growth strategy during an Investor Day in October 2024. The company focuses on developing healthcare solutions for transplant patients and caregivers.
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.
