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Landmark Longitudinal Examine in Over 1,00zero Transplant Sufferers Confirms AlloSure Extra Precisely Measures Organ Well being
SOUTH SAN FRANCISCO, Calif., Oct. 21, 2021 (GLOBE NEWSWIRE) — CareDx, Inc. (Nasdaq: CDNA) – a number one precision drugs firm centered on the invention, improvement, and commercialization of clinically differentiated, high-value healthcare options for transplant sufferers and caregivers – immediately congratulated OrganX on the completion of a landmark longitudinal study that reveals AlloSure is extra correct than present requirements of care, together with estimated glomerular filtration charge (eGFR) or donor particular antibody (DSA) testing, in detecting allograft rejection.
New knowledge on AlloSure Kidney was introduced on the European Society of Transplant Congress held in Milan in September 2021 and the summary revealed in Transplant Worldwide. In an evaluation of paired-biopsy outcomes of 1,196 kidney sufferers taken from 2013 to 2018, the research conclusively demonstrated that AlloSure® Kidney confirmed unbiased and incremental predictive functionality when in comparison with normal of care affected person monitoring, together with circulating anti-HLA DSA, eGFR, proteinuria, and incidence of a latest medical or immunologic occasion. The research reveals AlloSure Kidney detects each antibody mediated rejection (ABMR) and T-cell mediated rejection (TCMR) with nice accuracy and reproducibility.
OrganX was based by Alexandre Loupy, who additionally runs the Paris Transplant Group, a number one skilled in machine studying and synthetic intelligence to personalize transplant drugs. Whereas AlloSure Kidney has solely been available on the market for 3 years, OrganX’s longitudinal research was made doable by measuring dd-cfDNA ranges in kidney transplant sufferers from 2013 to 2018 utilizing saved blood samples.
“Higher, earlier knowledge offers transplant physicians alternatives to make extra knowledgeable selections sooner as they try to save lots of organs and lives all through the transplant journey,” mentioned Alexandre Loupy, MD PhD, OrganX founder and the principal research investigator. “Our knowledge confirms that AlloSure Kidney can extra precisely gauge the chance of immunologic occasions, giving extra correct info sooner than the usual of care.”
Confirmatory findings embrace:
Greater AlloSure-measured dd-cfDNA ranges have been noticed for T-cell mediated rejection (TCMR) and antibody mediated rejection (AMR)
Incremental rise in AlloSure-measured dd-cfDNA ranges correlated with rising Banff lesion scores for rejection exercise
No affiliation of AlloSure-measured dd-cfDNA ranges with allograft-inactive lesions
“That is the most important cohort of longitudinal, paired-biopsy outcomes ever collected evaluating AlloSure to the usual of care,” mentioned CareDx CEO Reg Seeto. “OrganX additional validates that AlloSure efficiency could be very sturdy, and we sit up for the total publication subsequent yr.”
CareDx, Inc., headquartered in South San Francisco, California, is a number one precision drugs options firm centered on the invention, improvement and commercialization of clinically differentiated, high-value healthcare options for transplant sufferers and caregivers. CareDx affords testing companies, merchandise, and digital healthcare options alongside the pre- and post-transplant affected person journey and is the main supplier of genomics-based info for transplant sufferers. For extra info, please go to: www.CareDx.com.
Ahead Wanting Statements
This press launch contains forward-looking statements associated to CareDx, Inc., together with statements concerning the outcomes of the OrganX longitudinal research of AlloSure® Kidney (the “Examine”), the prospects of AlloSure® Kidney and the power of AlloSure® Kidney to extra precisely gauge the chance of immunologic occasions, giving extra correct info sooner than the present requirements of care. These forward-looking statements are based mostly upon info that’s at the moment out there to CareDx and its present expectations, converse solely as of the date hereof, and are topic to dangers and uncertainties that would trigger precise outcomes to vary materially from these projected, together with dangers that the CareDx doesn’t notice the anticipated advantages of AlloSure® Kidney; the dangers that the outcomes of the Examine usually are not replicated in future research; basic financial and market components; and different dangers mentioned in CareDx’s filings with the SEC, together with the Annual Report on Kind 10-Okay for the fiscal yr ended December 31, 2020 filed by CareDx with the SEC on February 24, 2021 and different stories that CareDx has filed with the SEC. Any of those might trigger CareDx’s precise outcomes, efficiency or achievements to vary materially and adversely from these anticipated or implied by CareDx’s forward-looking statements. CareDx expressly disclaims any obligation, besides as required by legislation, or enterprise to replace or revise any such forward-looking statements.
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