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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 has secured a two-year tender with the French National Blood Service, Établissement Français du Sang, to supply its AlloSeq HCT chimerism monitoring solution for stem cell transplant patients. This contract highlights CareDx's innovation in the field as the first next-generation sequencing (NGS) solution approved by EFS. The selection process was competitive, with AlloSeq HCT being chosen for its superior sensitivity and rapid under 24-hour turnaround time. CareDx aims to enhance transplant patient care across France through this partnership.
CareDx, Inc. (Nasdaq: CDNA) announced a significant study published in Pediatric Transplantation that demonstrates the effectiveness of AlloSure in detecting allograft rejection in pediatric kidney transplant patients. The study, involving 67 patients tested from October 2017 to October 2019, shows that AlloSure offers a non-invasive and highly predictive method for early rejection detection, surpassing traditional indicators. This publication supports CareDx's commitment to improving long-term outcomes for young transplant recipients.
CareDx, a precision medicine company, will participate in the Piper Sandler 32nd Annual Virtual Healthcare Conference from December 1 to December 3, 2020. The company focuses on high-value healthcare solutions for transplant patients and their caregivers. A link to the fireside chat presentation will be available in the 'Investors' section of CareDx's website. Known for its genomics-based information services, CareDx is committed to enhancing patient care along the pre- and post-transplant journey.
CareDx, Inc. (Nasdaq: CDNA) announced a significant development regarding its AlloSure Heart test, which has received final reimbursement pricing of $2,753 from Palmetto MolDx. This donor-derived cell-free DNA test detects organ rejection in heart transplant patients and is covered by Medicare when paired with AlloMap Heart gene expression profiling. The combination, known as HeartCare, is a non-invasive solution aimed at enhancing patient management. CEO Reg Seeto emphasized that this milestone will improve heart transplant patient care accessibility.
CareDx, a leader in precision medicine for transplant patients, announced its participation in two virtual conferences. The Jefferies Virtual London Healthcare Conference is scheduled for November 17, 2020, at 10:50 AM EST, while the Canaccord Genuity Virtual MedTech & Diagnostics Forum is set for November 19, 2020, at 3:30 PM EST. Interested parties can access live webcasts on the company’s investor website. CareDx focuses on genomics-based solutions for transplant care, offering vital testing services and digital healthcare tools for patients and caregivers.
CareDx (Nasdaq: CDNA) announced a study published in Transplantation Direct indicating that AlloSure may effectively signal progression of BK virus (BKV) in transplant patients. The research utilized data from the Diagnosing Acute Rejection in Kidney Transplant Recipients (DART) study, revealing that AlloSure can distinguish asymptomatic BKV from BKV-associated nephropathy (BKVAN). This method could enhance patient care by reducing reliance on kidney biopsies, which have significant limitations. CareDx aims to expand the understanding of AlloSure to improve outcomes for transplant patients.
CareDx, Inc. (Nasdaq: CDNA) announced participation in the 2020 Pacific Northwest Virtual Kidney Walk to support kidney health, led by CMO Sasha King as chair of the event. Scheduled for November 8 at 10:00 AM PST, the virtual event aims to unite the kidney community and raise awareness for the 37 million Americans affected by kidney disease. This initiative highlights CareDx's commitment to patient advocacy and support for kidney transplant patients, especially during the pandemic.
CareDx, Inc. (Nasdaq: CDNA) announced pivotal management changes effective November 1, 2020. Peter Maag will transition from CEO to Executive Chairman, while Reginald Seeto, previously President and Chief Business Officer, steps in as the new CEO. Maag has led the company since 2012, overseeing significant growth and the IPO. The board expresses gratitude for his leadership and is optimistic about Seeto's experience and strategic vision to further enhance CareDx's position in precision medicine for transplant patients.
CareDx reported impressive financial results for Q3 2020, with total revenue reaching $53.4 million, a 58% increase from the previous year. Testing services revenue was $45.5 million, up from $28.2 million in Q3 2019. Despite this growth, the company posted a net loss of $2.8 million compared to a $1.8 million loss a year earlier. Non-GAAP net income was $5.1 million, up from $0.9 million, and adjusted EBITDA improved to $5.6 million. As of September 30, CareDx's cash reserves stood at $213.8 million, but revenue guidance is suspended due to COVID-19 uncertainties.
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