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RenalytixAI announced Friday that study data published in the Journal of Clinical Investigation (JCI) Insight suggest that its FractalDx portfolio technology can accurately predict early acute kidney rejection in transplant patients. The company said the findings, which were also presented at the American Transplant Congress (ATC), "support successful development of a predictive blood test for transplant patients."
In the GoCAR study, researchers used the FractalDx technology to perform whole-blood RNA sequencing at the time of transplant in 235 kidney transplant recipients and to evaluate the relationship of pretransplant transcriptomic profiles with early acute cellular rejection (EAR) occurring within six months after transplant. The scientists identified a 23-gene set that predicted early acute rejection and graft loss, while the risk score created from this set was also significantly associated with EAR six months after transplantation.
Commenting on the results, Christian Larsen, member of the RenalytixAI kidney transplant advisory board, remarked that "the availability of a non-invasive blood test prior to transplant…would represent a significant advance in the field." She added "this study offers the possibility to bring an individualised approach to [immunosuppression] therapy selection for kidney transplant recipients."
In January, RenalytixAI exercised its option from the Icahn School of Medicine at Mount Sinai for the exclusive license to technology and data underlying the FractalDx product portfolio. Shortly after, RenalytixAI initiated the planning process for clinical validation of the first diagnostic products using the FractalDx technology in conjunction with the company's core investigator group.
RenalytixAI suggested that the JCI data will help "further inform the ultimate validation study design, indicated use trial end-points and scope." The company noted that it plans to initiate the clinical validation programme in the second half of this year and to prepare in 2020 for a formal launch of the product as a laboratory developed test.
According to RenalytixAI, the FractalDx technology is based on sequencing biomarkers from a patient's blood using widely available instrument platforms. Products under development from the portfolio also include KidneyIntelX, which gained FDA breakthrough device designation last May and will be introduced this year for the diagnosis of fast-progressing chronic kidney disease.
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