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Patient Voice Needed: Access to post-transplant testing may be impacted

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In November of 2022 MolDX (a program charged with developing CMS coverage policies for molecular diagnostic tests) and Noridian (the Medicare Administrative Contractor for CareDx and other labs located in California) held advisory meetings to review the clinical evidence for post-transplant diagnostics products. This includes AlloSure and AlloMap.

These meetings may inform coverage for molecular diagnostic testing for transplant patients and could impact access to these tests.

CareDx recognizes that the patient voice is key when making these decisions as they add personal stories that make the products’ impact more concrete and real.

This is where you come in! We need your help to share your AlloSure or AlloMap story, and support for continued access to post-transplant care options through the below form. While doing so in your own words is best, we created a template which we hope would be helpful and allows you to send your letter of support directly to the agencies responsible for the review.

Send your letter of support here.

Thank you for your advocacy for the transplant community.

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Independent Longitudinal Study Finds CareDx’s AlloSure Detects Early Signs of Rejection in Pediatric Kidney Transplant Patients

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NOVEMBER, 01, 2022

First Pediatric Study to Evaluate Use of AlloSure dd-cfDNA as Biomarker for Allograft BK Infection

Findings Add to Growing Body of Evidence Showing Clinical Value of AlloSure for Surveillance in Pediatric Kidney Transplant Patients

BRISBANE, Calif.–(BUSINESS WIRE)– CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced the results of a new study published in the Clinical Journal of the American Society of Nephrology (CJASN)1 showing that CareDx’s AlloSure® Kidney donor-derived cell-free DNA (dd-cfDNA) solution identifies early signs of allograft rejection and BK virus infection in pediatric kidney transplant patients.
Read the complete press release on CareDx.com.

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Test to Predict Kidney Transplant Rejection Works for Children

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Cedars-Sinai Patient Pioneers Successful Pediatric Use of Test Developed for Adults

“In many ways 19-year-old, Brenna Kahlen is a typical teenager. She is living at home in Newport Beach, working and going to college. But unlike most of her peers, Brenna is a now a medical first.

Brenna was born with a disease known as tuberous sclerosis, which affected her kidneys. At age 11, she had both kidneys surgically removed and was placed on dialysis until she could receive a donated kidney.

The transplant happened in 2013 and Brenna “has done extremely well,” said Dechu Puliyanda, MD  Cedars-Sinai’s director of Pediatric Nephrology and Transplant Immunology, who oversees Brenna’s care”

Read the full story, here.

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