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SOUTH SAN FRANCISCO - CareDx, Inc. (NASDAQ:CDNA), a healthcare diagnostics company with a market capitalization of $808 million and impressive gross margins of 67%, announced new innovations in transplant diagnostics and European regulatory certifications for its HLA typing products at the American Society for Histocompatibility and Immunogenetics (ASHI) 2025 Annual Meeting, which began Monday in Orlando. According to InvestingPro analysis, the company’s stock appears undervalued at its current price of $15.19.
The company launched AlloSeq Tx11, an enhanced HLA typing solution featuring improved Class II coverage and incorporation of non-HLA markers including ABO, CCR5, LIMS1, and APOL1 to support broader transplant risk assessment. CareDx also introduced SCORE 7 Software, a modernized analysis application for its QTYPE rapid HLA typing product. The company’s strong financial health is evidenced by its healthy current ratio of 3.3 and solid revenue growth of 14.7% in the last twelve months. For deeper insights into CareDx’s financial metrics and growth potential, investors can access the comprehensive Pro Research Report available on InvestingPro.
Additionally, the company is offering early access to a novel HLA typing technology that provides same-day, long-read-based genotyping with rapid turnaround times.
CareDx revealed that its AlloSeq Tx and QTYPE products have received certification for compliance with the European Union’s In Vitro Diagnostic Regulation (IVDR), ahead of the December 2027 regulatory deadline for HLA-typing devices.
At the conference, the company is presenting research on a new ABO genotyping assay that demonstrated 100% concordance with established molecular methods across three clinical sites. The assay aims to improve ABO blood group determination in transplant settings, potentially expanding donor eligibility.
"This week at ASHI 2025, we will highlight our continued investment in creating life changing solutions that allow transplant patients to thrive," said John Hanna, President and Chief Executive Officer, in a press release statement. InvestingPro data reveals the company maintains a strong balance sheet with more cash than debt, positioning it well for continued innovation in the healthcare diagnostics sector.
CareDx is also hosting a user group meeting at the conference focused on ABO histocompatibility in transplantation, featuring experts from Brigham and Women’s Hospital, LifeLink Foundation, and the University of Alberta.
In other recent news, CareDx Inc. reported its second-quarter 2025 earnings, which showed a mixed performance. The company achieved an earnings per share of $0.10, exceeding the anticipated loss of $0.10, but it reported revenue of $86.7 million, which was below the expected $90.62 million, resulting in a revenue shortfall of 4.33%. Despite this, BTIG has reiterated its Buy rating on CareDx, albeit with a lowered price target of $22.00, down from $26.00, due to concerns over Medicare reimbursement proposals. BTIG also highlighted potential upside beyond the anticipated CMS decision, suggesting other important growth sources not currently reflected in the stock price. Meanwhile, William Blair initiated coverage on CareDx with a Market Perform rating, acknowledging potential improvements despite recent challenges such as reimbursement difficulties and patent litigation. The company has also tightened its full-year guidance range while maintaining the midpoint, projecting revenue of $370 million, which would represent an 11% year-over-year growth. These developments indicate ongoing challenges and opportunities for CareDx in the coming years.
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