New Publication Shows CareDx’s AlloSure May Be Effective for Monitoring BK Virus in Transplant Patients

Rhea-AI Summary

CareDx (Nasdaq: CDNA) announced a study published in Transplantation Direct indicating that AlloSure may effectively signal progression of BK virus (BKV) in transplant patients. The research utilized data from the Diagnosing Acute Rejection in Kidney Transplant Recipients (DART) study, revealing that AlloSure can distinguish asymptomatic BKV from BKV-associated nephropathy (BKVAN). This method could enhance patient care by reducing reliance on kidney biopsies, which have significant limitations. CareDx aims to expand the understanding of AlloSure to improve outcomes for transplant patients.

Positive

• AlloSure validated as a non-invasive test to assess BK virus progression.
• Study supports AlloSure's potential in identifying BK nephropathy in transplant patients.
• Findings may reduce dependence on kidney biopsies, offering a more accurate assessment.

Negative

• None.

Research from Johns Hopkins, University of Maryland, and Cedars Sinai Shows AlloSure May Signal BK Virus Progression in Transplant Patients

SOUTH SAN FRANCISCO, Calif., Nov. 06, 2020 (GLOBE NEWSWIRE) -- CareDx, Inc. (Nasdaq: CDNA), a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, announces today that the journal Transplantation Direct published Donor-derived cell-free DNA and the Prediction of BK virus-associated Nephropathy, showing AlloSure may be a useful non-invasive test to assess progression of BK virus.

BK virus (BKV) is a common viral infection in transplant patients that can lead to BKV-associated nephropathy (BKVAN). This study examined data from the Diagnosing Acute Rejection in Kidney Transplant Recipients (DART) study to evaluate if AlloSure can distinguish asymptomatic BKV from BKVAN. Study findings support the utility of AlloSure as a surrogate for predicting progression from BKV to BKVAN.

“Diagnosis of BKVAN relies on kidney biopsy, which has considerable limitations and subsequent discordance rates around 30%,” said lead investigator, Sam Kant, MD, Johns Hopkins University School of Medicine. “The findings in our publication may lead to improved care for transplant patients who are at risk of progressing to BKVAN.”

“We are pleased that the study findings show that AlloSure is further validated to not only provide an accurate assessment of allograft rejection, but also potentially identify BK nephropathy in transplant patients,” said Sham Dholakia, MD, Senior Vice President, Medical Affairs & Clinical Operations at CareDx. “Our goal is to continue expanding the base of knowledge on AlloSure that can lead to better outcomes for transplant patients.”

About CareDx
CareDx, Inc., headquartered in South San Francisco, California, is a leading precision medicine solutions company focused on the discovery, development and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients. For more information, please visit: www.CareDx.com.

Forward-Looking Statements

This press release includes forward-looking statements, including expectations regarding the achievement of our financial and operational goals and our prospects. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, including general economic and market factors, among others discussed in CareDx’s filings with the SEC, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2019, filed by CareDx with the SEC on February 28, 2020, and the periodic reports that CareDx has subsequently filed with the SEC. Any of these may cause CareDx’s actual results, performance or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.

CONTACTS:

CareDx, Inc.
Sasha King
Chief Marketing Officer
415-287-2393
sking@caredx.com

Investor Relations
Greg Chodaczek
347-610-7010
investor@caredx.com 

 

FAQ

What is the significance of CareDx's study on AlloSure published in November 2020?

The study suggests that AlloSure may accurately predict the progression of BK virus to BKV-associated nephropathy, improving patient care.

How does AlloSure relate to BK virus progression in transplant patients?

AlloSure is shown to differentiate between asymptomatic BK virus and BKV-associated nephropathy, aiding in non-invasive assessment.

What are the implications of the DART study findings for CareDx (CDNA)?

The findings validate AlloSure's use, potentially enhancing market position by offering improved diagnostic solutions for transplant patients.

When was the study regarding AlloSure and BK virus published?

The study was published on November 6, 2020.