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) operates at the forefront of transplant medicine, where product innovations, clinical trial results, and regulatory developments drive significant news flow. As a precision diagnostics company focused on organ transplantation, CareDx generates news related to clinical study publications, FDA and regulatory interactions, reimbursement policy changes, and product commercialization milestones. This news page provides comprehensive coverage of developments affecting the company's transplant surveillance and HLA typing businesses.
The types of news that matter most for CareDx include peer-reviewed study publications demonstrating clinical utility of its dd-cfDNA technology, Medicare coverage determinations that impact reimbursement for surveillance testing, product launches expanding into new transplant types or international markets, and earnings reports revealing testing volume trends. Additionally, significant 8-K filings may disclose material events such as partnership agreements with transplant centers, changes in reimbursement policies, or intellectual property developments. Understanding these news categories helps investors track the company's progress in validating its technology platform and expanding commercial adoption.
CareDx's news flow reflects the biotech and diagnostics industry's focus on evidence generation and regulatory milestones. Clinical data presentations at major transplant medicine conferences like the American Transplant Congress and American Society of Nephrology provide insights into product performance and physician adoption trends. Regulatory submissions for expanded product indications, international certifications, and coverage policy updates from insurers represent critical catalysts that can accelerate or constrain market penetration for the company's diagnostic services.
CareDx, Inc. (NASDAQ: CDNA) has announced a stock repurchase program authorized by its Board of Directors, allowing for up to $50 million in stock buybacks over 24 months. The program enables discretionary purchases via open market repurchases, private transactions, and trading plans. CEO Reg Seeto expressed confidence in the company's financial position and growth prospects, stating that share buybacks reflect their commitment to long-term shareholder value. The repurchases will utilize existing cash and future cash flow.
CareDx, Inc. (Nasdaq: CDNA) announced the results of a significant study in the Transplantation Direct journal, establishing a reference baseline for using AlloSure® Lung in lung transplant patient surveillance. Conducted at Vanderbilt University Medical Center, the study involved 51 patients and defined a 73% reference change value for AlloSure dd-cfDNA levels two years post-transplant. This data underscores the clinical utility of AlloSure Lung, currently utilized by 60% of lung centers, as a vital tool amid high lung graft failure rates.
CareDx, Inc. (Nasdaq: CDNA) celebrated the five-year anniversary of AlloSure, a non-invasive solution for monitoring organ transplant health. The company emphasized its leadership in transplant research, with over 100 peer-reviewed publications supporting the clinical use of AlloSure and AlloMap. Having invested more than $200 million in research over the past three years, CareDx continues to enhance transplant outcomes, addressing the significant need for accurate biomarkers in organ transplants.
CareDx, Inc. (Nasdaq: CDNA), a leader in precision medicine for transplant patients, will participate in two investor conferences. The first presentation is at the Credit Suisse 31st Annual Healthcare Conference on November 9, 2022, at 1:25 PM ET, accessible via their website. The second is at the Jefferies London Healthcare Conference on November 15, 2022, at 8:30 AM ET. CareDx aims to enhance healthcare solutions for transplant patients and caregivers through innovative testing services and digital solutions.
CareDx, Inc. (CDNA) reported its Q3 2022 financial results, achieving revenue of $79.4 million, a 5% increase year-over-year. The number of patient test results grew by 15%, totaling 46,500. Despite a strong GAAP gross margin of 73%, the net loss widened to $16.9 million, with a loss per share of $0.32. Adjusted EBITDA showed a loss of $2.5 million, contrasting with a gain in Q3 2021. The company has adjusted its 2022 revenue guidance to $320-$325 million due to a shift in payer mix.
CareDx, the Transplant Company, recently announced its participation in the ASN Kidney Week 2022, where it will present data on AlloSure Kidney and digital health solutions. This event, taking place from November 3-6 in Orlando, Florida, is an opportunity for CareDx to showcase its commitment to improving transplant patient care. The company will feature nine abstracts highlighting AlloSure's role in post-transplant surveillance, supported by findings from the groundbreaking ADMIRAL study, which demonstrated AlloSure's predictive capabilities for long-term graft survival.
CareDx, Inc. announced a study published in the Clinical Journal of the American Society of Nephrology demonstrating the efficacy of AlloSure® dd-cfDNA as a biomarker for early detection of allograft rejection and BK virus infection in pediatric kidney transplant patients. This independent study involved 57 patients and showed significant results, including an AUC of 0.82 for acute rejection detection. The findings emphasize AlloSure's potential for improving transplant outcomes through timely interventions, supporting CareDx's position as a leader in transplant innovation.
CareDx, Inc. (NASDAQ: CDNA) has congratulated C-Path’s Transplant Therapeutics Consortium and the Paris Transplant Group for receiving European Medicine Agency's draft qualification for the iBox Scoring System, a significant step in kidney transplant trials. The iBox system evaluates graft failure risk by assessing renal function and immunologic responses. CEO Reg Seeto expressed pride in collaborating with these groups to further transplant innovation.
CareDx, Inc. (NASDAQ: CDNA) will report its financial results for Q3 2022 on November 3, 2022, after market close. A conference call will follow at 1:30 p.m. PT / 4:30 p.m. ET. Interested parties can listen by dialing 1-800-289-0438 for domestic calls or 1-323-794-2423 for international calls, using Conference ID: 2768596. The call will also be available via a live webcast on the company's investor relations website.
CareDx, Inc. (CDNA) announced a webinar in collaboration with the National Kidney Foundation and Honor the Gift Coalition to assist kidney transplant patients with Medicare enrollment related to the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2020, effective January 1, 2023. The webinar, titled "2023 Medicare Immunosuppressant Coverage: What Patients Need to Know," will take place on October 27, 2022, covering patient eligibility and coverage options. CareDx's initiative reflects its commitment to improving patient access to essential immunosuppressive treatments.
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