Liquid Biopsy Platform Demonstrates High Diagnostic Capabilities In Early Stages of Nasopharyngeal Carcinoma

Attendees during American Society of Clinical Oncology (ASCO) Annual Meeting. Courtesy: © ASCO/Scott Morgan
Attendees during American Society of Clinical Oncology (ASCO) Annual Meeting. Courtesy: © ASCO/Scott Morgan

Commercial-stage medical technology company Laboratory for Advanced Medicine (LAM) announced positive results from a new study that evaluated DNA methylation-based marker panel for early diagnosis of nasopharyngeal carcinoma (NPC).

The data will be presented in an online only abstract as part of the annual meeting of the American Society of Clinical Oncology (ASCO), taking place in Chicago, Ill., May 31 to June 4, 2019.[1]

ASCO

Nasopharyngeal carcinoma (NPC) is the 3rd most prevalent malignancy among men in Southern China and the 4th most common cancer in Hong Kong, constituting one of the most prevalent malignancies among populations native to Southeast Asia, the Mediterranean Basin and the Arctic. Early diagnosis of NPC with the identification of cancer-specific DNA methylation patterns of cell-free DNA isolated from blood samples is predicted to improve survival.

“The changes in DNA methylation level commonly disrupt molecular signaling mechanisms and lead to the formation and progression of malignant tumors,” said Dhruvajyoti Roy, Ph.D, Director of Technology at Laboratory for Advanced Medicine.

“The early detection of these changes can provide patients with the key advantage of time for a successful treatment,” Roy added.

IvyGene, is a blood test that uses advanced DNA sequencing methods to detect the DNA methylation pattern of cfDNA in blood samples to detect the presence of cancer and give quantifiable information about the cancer. It differs from genetic tests that are based on DNA mutations that provide patients only information about their propensity or likelihood for the development of cancer. The IvyGene test is based on DNA methylation which provides confirmation of cancer at the time of testing.

The new data from the study further validate and demonstrate the high diagnostic potential of LAM’s cell-free DNA methylation assay to non-invasively diagnose a new cancer type, nasopharyngeal carcinoma, with high specificity and sensitivity.

The results of the study show an overall sensitivity of 97% and a combined specificity of 100%, demonstrating the high analytical potential of the IvyGene Test. The study was conducted using samples obtained from 168 subjects, including 59 subjects diagnosed with NPC (Stage I to IV), 14 subjects diagnosed with benign nasopharyngeal disease and 43 healthy subjects.

From the 59 subjects diagnosed with NPC, a total of 57 subjects were correctly identified (sensitivity of 97%), with little difference between the sensitivity of detecting Stage I to Stage IV NPC (range 92% to 100%). Additionally, for subjects diagnosed with other cancers, a total of 86% of subjects were correctly identified as negative for NPC. Finally, all 43 samples drawn from healthy donors and all 14 samples drawn from subjects diagnosed with benign nasopharyngeal disease were correctly identified as negative for NPC (combined specificity of 100%).

Reference

[1] Roy D, Taggart DJ, Zheng L, Liu D, Li G, Li M, Zhang K, Van Etten RA. Cell-free DNA methylation markers for noninvasive early detection of nasopharyngeal carcinoma. J Clin Oncol 37, 2019 (suppl; abstr e14537) [Abstract]