CareDx links elevated AlloSure Kidney to worse transplant outcomes
A 131-patient registry analysis found higher graft risk, while a separate randomized trial reported 49% fewer kidney biopsies.
Adrian Kessler
Elevated AlloSure Kidney results were associated with nearly three times the risk of poor transplant outcomes, as CareDx, Inc. NASDAQCDNA reported registry findings on Thursday. The 131-patient analysis supports risk assessment, but does not establish that treatment guided by the test prevents graft loss.
The ASN abstract compares 40 recipients with donor-derived cell-free DNA of at least 1 per cent against 91 below that threshold. Tests and biopsies were paired within a 30-day window. Its endpoint combined graft loss with a decline of at least 30 per cent in estimated glomerular filtration rate, a measure of kidney function.
CareDx is a midsized diagnostics company based in Brisbane, California, that provides molecular testing and patient support for transplants, oncology and cell therapy.
The NASDAQCDNA close was US$70.74 at 4 p.m. EDT on Oct. 21, before the announcement. CareDx reports third-quarter results on Oct. 29, providing the next check on testing demand.
The KOAR cohort included 66 recipients with borderline biopsy changes and 65 with T-cell-mediated rejection. Follow-up ran from biopsy until an outcome or administrative censoring three years after transplantation.
The adjusted hazard ratio was 2.78, with a 95 per cent confidence interval of 1.43 to 5.40. The association had a P value of 0.002, while subsequent rejection rates did not differ significantly between groups. Because this was a registry comparison, it cannot establish that changing treatment based on the result improves graft survival.
"Combined with the long-term outcome data presented at this year’s ATC, the evidence increasingly supports the use of AlloSure Kidney to help clinicians assess risk and guide patient management," CareDx chief medical officer Jeffrey Teuteberg said in the Oct. 22 release.
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Randomized Monitoring Reduced Biopsies
CareDx also highlighted a randomized trial scheduled for presentation Thursday involving 332 recipients assigned to cell-free DNA monitoring or invasive biopsy monitoring. The groups included 168 and 164 patients, respectively.
The primary endpoint was biopsy frequency between months three and 12 after transplantation. Blood-marker monitoring reduced biopsies by 49 per cent, with an incidence rate ratio of 0.51 and P below 0.001.
Death or graft loss occurred in 7.1 per cent of the blood-test group and 6.1 per cent of controls. Acute rejection and kidney function were also reported as similar, but the abstract's one-year outcomes leave longer-term graft preservation unresolved.
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Rival Tests Already Assess Rejection Risk
Natera, Inc. NASDAQNTRA offers Prospera, a blood test assessing kidney transplant rejection risk. Eurofins Scientific SE EPAERF describes its TRAC assay as measuring donor-derived cell-free DNA after transplantation. Neither ASN study directly compared AlloSure with those competing tests.
The broader biotechnology benchmark, the iShares Biotechnology ETF NASDAQIBB, closed at US$211.55 at 4 p.m. EDT on Oct. 21.
CareDx's July 30 financial release reported approximately 58,000 tests in the June quarter, up 17 per cent from a year earlier. That volume covers testing services across its portfolio, rather than AlloSure alone.
Testing-services revenue rose 61 per cent to US$100 million in the June quarter, including revenue recognized for earlier tests. Excluding that prior-period revenue, testing-services growth was approximately 28 per cent. CareDx generated US$31 million of operating cash in the quarter.
The KOAR poster, FR-PO1194, is scheduled for Oct. 23 at Kidney Week. CareDx's Oct. 29 results will show whether testing-volume growth continued through the September quarter.
