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BRISBANE, Calif. - CareDx, Inc. (NASDAQ:CDNA), a healthcare diagnostics company with a solid financial health score of 2.83 according to InvestingPro, announced that its AlloSure donor-derived cell-free DNA (dd-cfDNA) test demonstrated significant clinical utility in kidney transplant surveillance, according to findings from the Kidney Allograft Outcomes AlloSure Registry (KOAR) study published in the American Journal of Transplantation.
The prospective study, which enrolled 1,743 patients across 56 U.S. transplant centers and collected 18,584 AlloSure tests, found that elevated AlloSure levels were associated with a 6-fold increase in rejection detection for surveillance biopsies (39% versus 7%) and a 4-fold increase for cause-driven biopsies (47% versus 12%). The company’s strong market position is reflected in its impressive 67.6% gross profit margin and robust revenue growth of 25.9% over the last twelve months.
The research showed that AlloSure elevations were detectable up to four months before antibody-mediated rejection (ABMR) and one month before T-cell mediated rejection (TCMR), suggesting potential for earlier intervention. Additionally, dd-cfDNA levels correlated with rejection severity, with higher levels linked to more severe rejection types.
"AlloSure empowers physicians to detect rejection earlier and intervene more precisely," said Robert Woodward, Chief Scientific Officer of CareDx, in the press release statement.
The study also demonstrated that following treatment, AlloSure levels declined significantly while serum creatinine remained unchanged, indicating the test’s potential value in monitoring treatment response.
Daniel C. Brennan, Professor of Medicine at Johns Hopkins and study author, described KOAR as "landmark" research, stating that "dd-cfDNA should be considered the first-line test even before DSA [donor-specific antibodies]."
The KOAR study followed a testing protocol based on the earlier DART study, prescribing seven tests in year one and four annually in years two and three post-transplant.
CareDx markets itself as "The Transplant Company" and focuses on precision medicine solutions for transplant patients and caregivers. According to InvestingPro analysis, the company appears undervalued at current levels, with a strong balance sheet showing more cash than debt. For detailed insights and additional ProTips on CareDx’s financial outlook, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.
In other recent news, CareDx, Inc. reported an 18% increase in first-quarter revenue year-over-year, reaching $84.7 million. The company also completed a $50 million stock buyback program, repurchasing approximately 5% of its outstanding shares. CareDx maintains a strong financial position with $231 million in cash, cash equivalents, and marketable securities, and no debt. Additionally, CareDx launched AlloSure Plus, an AI-driven diagnostic platform for transplant patients, initially integrating with EPIC Aura at select sites. The platform was validated by an international study involving over 2,700 renal transplant biopsies. Furthermore, a draft Medicare Local Coverage Determination proposes to continue coverage for molecular surveillance testing for transplant patients, introducing a bundled payment concept. This draft policy is open for public comment and aims to maintain current coverage policies.
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