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CareDx Inc

CareDx, Inc. provides solutions for improving outcomes for transplant patients and advancing organ health in the United States and internationally. The company provides AlloSure Kidney, a donor-derived cell-free DNA (dd-cfDNA) solution for kidney transplant patients; AlloMap Heart, a gene expression profiling solution for heart transplant patients; AlloSure Heart, a dd-cfDNA solution for heart transplant patients; and AlloSure Lung, a dd-cfDNA solution for lung transplant patients. It also offers HeartCare, which provides information about distinct biological processes, such as immune quiescence, active injury, acute cellular rejection, and antibody mediated rejection; HistoMap Kidney, a solution that identifies allograft rejection and type of rejection in kidney transplant biopsy tissue; and AlloHeme, a monitoring test that predicts relapse in patients with acute myeloid leukemia and myelodysplastic syndromes. In addition, the company provides QTYPE that enables precision in human leukocyte antigen (HLA) typing; Olerup SSP, which is used to type HLA alleles based on sequence specific primer technology; and Ottr, a transplant patient management software. Further, it offers AlloSeq Tx, a high-resolution HLA typing solution; AlloSeq cfDNA, a surveillance solution to measure dd-cfDNA in blood; AlloSeq HCT, a solution for chimerism testing for stem cell transplant recipients; Allocell, a solution that monitors the pharmacokinetics of engraftment and persistence of cells for patients who have received allogeneic cell therapy; and XynQAPI, MedActionPlan, CareDx pharmacy, AlloHome, and HLA Data Systems software solutions. It has a license agreement with Illumina, Inc. for the distribution, development, and commercialization of NGS products and technologies. The company was formerly known as XDx, Inc. and changed its name to CareDx, Inc. in March 2014. The company was incorporated in 1998 and is headquartered in Brisbane, California.

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Biotech & Genomic Medicine

Baron Discovery Fund Accumulated CareDx Shares During Reimbursement Uncertainty

Baron Discovery Fund disclosed it meaningfully increased its position in CareDx during the third quarter of 2025 when shares traded between $11 and $12, viewing the price as reflecting a worst-case scenario around a draft Medicare coverage decision. The draft local coverage decision from the CMS MolDX Program proposed limiting reimbursement for CareDx's transplant diagnostic tests, including removing increased coverage for HeartCare and introducing a bundled payment model. CareDx shares have since recovered to the high-$20s as investors recognized the LCD process involves ongoing dialogue, and the company reported first-quarter 2026 revenue up 39% year over year with testing volumes up 17%. CareDx also announced the divestiture of its lab products business and the acquisition of Naveris, marking its entry into head and neck cancer testing.
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Biotech & Genomic Medicine

Five Biotech Stocks Deliver Big Gains With Key Catalysts Ahead

Five biotech stocks featured on RTTNews have delivered substantial gains, with upcoming catalysts that could drive further upside. uniQure N.V. surged 186% since August 2025, driven by positive data for its Huntington's disease gene therapy AMT-130, and is on track to submit regulatory filings in the third quarter of 2026. CareDx Inc. gained 138% since June 2025 after a series of strong earnings reports, raised guidance, and the acquisition of Naveris, with the commercial launch of the NavDx liquid biopsy test as a key catalyst. Adaptive Biotechnologies Corp. rose 130% since May 2025, supported by growing adoption of its clonoSEQ MRD test and multiple guidance raises, with the planned separation of its Immune Medicine business as a potential catalyst. Enliven Therapeutics Inc. jumped 207% since November 2025 on positive Phase 1 data for its chronic myeloid leukemia drug ELVN-001, and expects to initiate a Phase 3 trial in the second half of 2026. Amylyx Pharmaceuticals Inc. climbed 217% since June 2025, with a pivotal Phase 3 data readout for its post-bariatric hypoglycemia drug Avexitide anticipated in the third quarter of 2026.
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CareDx lifts full-year guidance after second-quarter revenue surges 52%

CareDx raised its full-year sales and earnings forecast after reporting second-quarter revenue that surged 52% year over year to $132 million. The precision medicine diagnostics company now expects full-year revenue of $490 million to $500 million, up from a prior forecast of $447 million to $465 million, and adjusted EBITDA of $66 million to $78 million, up from $43 million to $57 million. Adjusted net income more than tripled to $20 million, or $0.37 per share, well above Wall Street estimates of $0.23. The company said demand for its non-invasive transplant monitoring tests was strong, and it recently completed the acquisition of oncology diagnostics provider Naveris.
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CDNAimpact 4

CareDx shares surge 35.6% after Medicare finalizes transplant testing coverage

CareDx shares rallied 35.6% in the last trading session to close at $40.34 on heavy volume. The jump followed the company's announcement that the Medicare Local Coverage Determination process for molecular testing related to solid organ allograft rejection has been finalized, with the policy affirming coverage across CareDx's transplant surveillance offerings in kidney, heart, and lung. The molecular diagnostics company is expected to report quarterly earnings of $0.22 per share, a year-over-year increase of 120%, on revenues of $114.35 million, up 31.9% from the prior-year quarter. The stock currently carries a Zacks Rank of 3, or Hold.
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Biotech & Genomic Medicine

Biotech Stocks CareDx, Integra, Agilon, Bioventus, Enliven Hit 52-Week Highs

Several biotech stocks reached 52-week highs on July 16, 2026, driven by upcoming quarterly reports and conference participation. CareDx saw its stock hit a 52-week high of 40.38%, rising over 25% intraday, after announcing Medicare coverage for its AlloSure, AlloMap, and AlloSeq transplant rejection tests and reporting a 39% first-quarter revenue increase to $118 million. Integra LifeSciences shares rose over 5% to a 52-week high of $20.26, supported by recent product approvals and first-quarter revenue of $391.9 million. Agilon Health, which serves over 536,000 senior members through its subscription platform, expects full-year 2026 revenue of $5.68 billion. Bioventus touched a 52-week high of $12.53, rising over 3%, with first-quarter revenue up 7% to $132 million. Enliven Therapeutics shares rose over 6% to a 52-week high of $53.89 following encouraging interim data for its leukemia drug candidate and a recent public offering that raised about $460 million.
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Biotech & Genomic Medicineimpact 4

CareDx Soars on Medicare Coverage, AtaiBeckley Acquired by Eli Lilly, Abbott Lifts Outlook

Biotech stocks surged Thursday, led by CareDx which soared over 35% after Medicare finalized a policy confirming coverage for its transplant surveillance portfolio, including AlloSure Kidney and AlloMap Heart, effective August 30, 2026. AtaiBeckley jumped more than 33% on news it will be acquired by Eli Lilly in a deal valued at up to $3.8 billion, comprising $2.8 billion in upfront cash and up to $1.0 billion in contingent value rights tied to milestones for its depression treatments BPL-003 and VLS-01. Abbott Laboratories gained over 10% after reporting second-quarter net sales of $12.6 billion, a 13% increase, and raising its full-year adjusted earnings per share outlook to a range of $5.45 to $5.60. Apollomics added another 21%, bringing its weekly gain to more than 60%, as its lead candidate Vebreltinib advances in a Phase 2 trial for clear cell sarcoma and the company regained Nasdaq compliance. Virax Biolabs rose 13% after its CEO highlighted a narrowed net loss of $5.0 million, a $3.3 million capital raise, and a supply agreement with Fosun Diagnostics, while Entera Bio climbed over 12% ahead of a planned Phase 3 trial for its oral osteoporosis tablet EB613.
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Biotech & Genomic Medicine

CareDx Completes Acquisition of Naveris for Approximately $260 Million

CareDx has completed its acquisition of precision oncology company Naveris for an upfront cash payment of $160 million, with up to an additional $100 million payable upon achieving specified revenue milestones. The deal adds Naveris' proprietary NavDx liquid biopsy platform, which detects tumor-derived circulating DNA for cancer monitoring, to CareDx's portfolio. Naveris will be included in CareDx's consolidated financial results starting in the third quarter of 2026. CareDx shares closed Wednesday at $29.25, up 2.63%.
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Biotech & Genomic Medicine

CareDx Acquires Naveris, Extends Leadership into High-Growth Specialty Oncology

CareDx has completed the acquisition of Naveris, which includes its leading product NavDx, a blood-based test for viral-mediated cancer detection including human papillomavirus and associated head and neck and anal cancers. NavDx is the first and only Medicare-covered test for HPV-driven head and neck and anal cancer molecular residual disease surveillance. CareDx also has a portfolio of precision diagnostic testing services directed to a U.S. market estimated to exceed $12 billion. John Hanna, CareDx President and CEO, stated that NavDx fits the company's growth model of commercializing category-leading, repeat molecular biomarker testing for patients with a high burden of disease, and is expected to be a meaningful contributor to CareDx's growth from day one.
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U.S. Supreme Court Rejects CareDx Appeal in Natera False-Advertising Dispute

The U.S. Supreme Court declined to hear CareDx's appeal in its false-advertising dispute with Natera, leaving intact lower-court rulings that denied CareDx damages over claims involving kidney transplant tests. The justices offered no explanation for their decision not to review whether CareDx was owed damages for allegedly misleading advertisements comparing Natera's Prospera test with CareDx's AlloSure test. In 2023, U.S. District Judge Colm Connolly overturned a nearly $45 million jury damages award after finding no evidence that Natera's statements actually misled customers, though he confirmed the jury's finding of false advertising. The 3rd U.S. Circuit Court of Appeals later affirmed that ruling. A Natera spokesperson said the firm was pleased with the outcome, while CareDx had argued that courts should presume deception when advertising is deliberately false.
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CareDx CEO John Hanna Sells 17,683 Shares for $425,000

CareDx President and CEO John Hanna sold 17,683 shares of common stock in an open-market transaction on June 15, according to an SEC Form 4 filing. The sale was executed at a weighted average price of approximately $24.03 per share, yielding a total transaction value of roughly $425,000. The disposed shares represented 2.7% of Hanna's direct holdings, leaving him with 631,959 shares directly owned. The transaction was conducted under a pre-established Rule 10b5-1 trading plan and is part of a series of four sell transactions since April 1, 2026, indicating a consistent liquidity program rather than an exceptional event.
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