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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 and Dovetail Genomics have announced a strategic partnership to advance HLA genotyping for organ and stem cell transplant matching. The collaboration combines CareDx's AlloSeq Tx 17, the first HLA typing solution covering 17 loci, with Dovetail's Hi-C LinkPrep technology to achieve high-resolution genotyping and haplotyping without family studies. The partnership includes an Early Access Program for HLA labs to evaluate innovative donor-recipient matching methods. The combined technology's performance will be presented at the 50th annual ASHI meeting.
CareDx, Inc. (Nasdaq: CDNA) announced new data and product enhancements at the 50th annual meeting of the American Society for Histocompatibility and Immunogenetics (ASHI) in Anaheim, California. The company showcased advancements in its AlloSeq NGS-based HLA typing solutions for living organ donation and bone marrow transplantation. CareDx also launched an improved QTYPE solution with single bead antigen resolution for faster transplant decisions in deceased donor typing.
The company is hosting a symposium featuring Dr. Annette M. Jackson from Duke University, who will discuss findings on risk haplotypes in pediatric nephrotic syndrome. CareDx representatives will present innovations including a novel HLA haplotyping approach and QTYPE advancements. Key data presentations at ASHI 2024 will highlight the performance of AlloSeq Tx 11, buccal swab performance with AlloSeq Tx 17, and a new approach to HLA haplotyping using LinkPrep reagents with AlloSeq technology.
CareDx, Inc. (Nasdaq: CDNA) reported preliminary financial results for the third quarter of 2024. The company expects:
- Revenue between $82-83 million, up ~23% year-over-year
- Testing Services volume of ~44,600, up ~16% year-over-year
- Testing services revenue of $60-61 million, up ~26% year-over-year
- Patient and Digital Solutions revenue of ~$11.9 million, up 20% year-over-year
- Products revenue of ~$10.2 million, up 7% year-over-year
CareDx ended the quarter with ~$240 million in cash, cash equivalents, and marketable securities, with no debt. The company will report full Q3 2024 results on November 4, 2024, after market close, followed by a conference call at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time.
CareDx, Inc. (Nasdaq: CDNA), a precision medicine company focused on transplant healthcare solutions, has announced an inducement grant for its newly appointed Chief Data and AI Officer, Jing Huang. On October 8, 2024, Ms. Huang was granted 15,547 restricted stock units (RSUs) and an option to purchase 22,248 shares of CareDx common stock. The RSUs will vest over four years in equal annual installments starting October 8, 2025. The stock option, with an exercise price of $32.16, will vest over four years, with 25% vesting on October 8, 2025, and the remainder vesting monthly thereafter. This grant was made under CareDx's 2019 Inducement Equity Incentive Plan, approved by the Compensation Committee in accordance with Nasdaq Listing Rule 5635(c)(4).
CareDx, Inc. (Nasdaq: CDNA), a leading precision medicine company focused on transplant healthcare solutions, has announced its upcoming Investor Day on October 15, 2024, in New York City. The event will begin at 8:00 a.m. Eastern Time / 5:00 a.m. Pacific Time and will feature presentations from the company's leadership team.
Interested individuals can attend the event in person by registering online, but capacity is For those unable to attend, a live webcast will be available on the investor relations section of CareDx's website. A replay of the event will be posted on the company's website and will be accessible for at least 30 days after the event.
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.
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