Natera, San Carlos, Calif, a genetic testing and cell-free DNA analysis company, has partnered with Fox Chase Cancer Center to assess the company’s Signatera customized, circulating tumor DNA (ctDNA) assay for recurrence monitoring of patients with kidney cancer.
The study will analyze biological specimens collected and banked from 49 patients diagnosed with kidney cancer, including a group whose cancer recurred and a group whose cancer did not recur after 3 years or more.
Phillip Abbosh, MD, PhD, Fox Chase Cancer Center.
The study will assess whether the company’s Signatera proprietary, customized, research use only assay and next-generation sequencing (NGS) can distinguish between recurring and nonrecurring kidney cancer cases. The study will be led by Philip Abbosh, MD, PhD, an assistant professor in the molecular therapeutics program at Fox Chase Cancer Center.
“There is a paucity of data for circulating tumor DNA in kidney cancer. This research study will explore a novel approach for disease recurrence and treatment response monitoring in kidney cancer, since existing methods have limitations with sensitivity and specificity,” says Abbosh. “Determining the relationship between kidney cancer genetic profiles and prognosis, including recurrence, using the Signatera assay has great potential to improve patient care by detecting cancer recurrence earlier, assisting adjuvant therapy decisionmaking, determining treatment effects, and assessing the need for intervention during follow-up.”
Kidney cancer is among the 10 most common cancers in both men and women.1 According to the American Cancer Society, more than 60,000 new cases of kidney cancer will be diagnosed this year, and nearly15,000 people will die from the disease.1
The kidney cancer study joins a growing number of research collaborations that Natera has established over the past 18 months involving a variety of cancer types, including bladder, breast, colorectal, and lung cancers.
C. Jimmy Lin, MD, PhD, MHS, Natera.
“We look forward to working with Fox Chase Cancer Center,” says C. Jimmy Lin, MD, PhD, MHS, Natera’s chief scientific officer for oncology. “We expect that this study, along with our ongoing research efforts in other cancer types, will help us move toward clinically validating Signatera, with the goal of enabling more precise monitoring, better determination of prognosis, and individualized treatment of disease.”
Signatera is the first ctDNA assay custom-built for treatment monitoring and minimal residual disease assessment. The methodology differs from currently available liquid biopsy assays, which test for a panel of genes independent of an individual’s tumor. By contrast, Signatera provides each patient with a customized blood test tailored to match the mutations found in that individual’s tumor tissue, thereby maximizing the sensitivity and specificity of the test. The assay also allows researchers to track up to several hundred additional mutations of interest.
A recent study demonstrated the ability of the Signatera assay to detect residual disease, measure treatment response, and identify recurrence up to 11 months earlier than the standard of care for early-stage, non-small cell lung cancer.2 Additional research presented at the 2018 meeting of the American Association for Cancer Research showed successful results in studies involving bladder and colorectal cancer, including median detection points of ctDNA that were 4.3 and 7.9 months ahead of clinical relapse detection, respectively.3,4
References
- Key statistics about kidney cancer [online]. Atlanta: American Cancer Society, 2018. Available at: http://www.cancer.org/cancer/kidney-cancer/about/key-statistics. Accessed July 26, 2018.
- Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545(7655):446–451; doi: 10.1038/nature22364.
- Birkenkamp-Demtröder K, Christensen E, Sharma S, et al. Sequencing of plasma cfDNA from patients with locally advanced bladder cancer for surveillance and therapeutic efficacy monitoring [abstract 3653]. Presentation at the annual meeting of the American Association for Cancer Research, Chicago, April 14–18, 2018. Cancer Res. 2018;78(Suppl 13):abstract no. 3653; doi: 10.1158/1538-7445.am2018-3653.
- Reinert T, Henriksen TV, Rasmussen MH, et al. Personalized circulating tumor DNA analysis to monitor colorectal cancer [abstract 1590]. Presentation at the annual meeting of the American Association for Cancer Research, Chicago. April 14–18, 2018. Cancer Res. 2018;78(Suppl 13):abstract no. 1590; doi: 10.1158/1538-7445.am2018-1590.
