Natera, Inc. (NASDAQ:NTRA), a pioneer and global leader in cell-free DNA, announced an expansive program to improve care for organ transplant patients with a history of cancer, using the Signatera™ test for molecular residual disease (MRD) assessment pre- and post-transplant, in combination with the Prospera™ test for transplant rejection assessment. The goal of the program is to understand how the Signatera and Prospera tests can be used to improve decision making at the complex intersection of organ transplantation and oncology, and respond to the unmet needs within these communities.
"This research program promises to be a significant advance in personalized care for transplant patients with cancer, or with a history of cancer," said Michael Volk, MD, Division Head, Gastroenterology and Hepatology, Loma Linda University Medical Center. "Not only can it help us better understand these patients' risk as they undergo evaluation for liver and kidney transplantation, but it will inform the development of guidelines for tailored monitoring and timely treatment, an area in which data is sorely lacking."
A significant number of patients being evaluated for a transplant have a history of cancer, as patients with end-stage renal disease have a 20% higher rate of colorectal cancer than the general population,1 making it difficult for patients to receive a transplant due to the uncertain risk of recurrence. Furthermore, this is exacerbated by the fact that transplant recipients require immune-suppressing medications to avoid rejection, which can increase the risk of new or recurring cancers. There is a large unmet need for more precise, data-driven clinical practice guidelines for the assessment and management of these patients who may be denied life-saving organ transplants based on their history of cancer.
The initial phase of Natera's program encompasses three study concepts that will be discussed in depth at the virtual TTS 2020 symposium on September 14th, 2020, in a presentation entitled, "The Interface of Solid Organ Transplant and Oncology: A New Paradigm with Cell-Free DNA" featuring Dr. Michael Volk, Division Head, Gastroenterology and Hepatology, Loma Linda University Health, and Dr. Kenar Jhaveri, Associate Chief of Kidney Diseases and Hypertension, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell. The main goals are:
- Help patients with colorectal cancer to be actively listed for and receive a needed kidney transplant earlier. This will be examined in the Colorectal Neoplasm in Candidates Enlisting for Renal Transplantation study (CONCERT)
- Track hepatocellular cancer recurrence post-liver transplant for earlier, faster, and more effective intervention in the observational study of Signatera in Liver Cancer (SIGNAL)
- Understand unique organ rejection dynamics in cancer patients through the Prospera in Renal Allograft Recipients with Cancer study (PARC)
"Natera is one of the only molecular diagnostics companies with solutions in both oncology and organ transplant and thus is uniquely positioned to help the medical community improve patient outcomes," said Paul Billings, MD, PhD, Chief Medical Officer and SVP of Medical Affairs at Natera. "This important program gives us the opportunity to leverage the biological and medical synergy between transplant and oncology using highly accurate, non-invasive methods."
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