LAM's IvyGene Liquid Biopsy Platform Demonstrates High Diagnostic Capabilities In New Cancer Indication

IRVINE, Calif., May 15, 2019 /PRNewswire/ -- Laboratory for Advanced Medicine (LAM), a commercial-stage medical technology company focused on developing innovative technologies for the early diagnosis of cancers, today announced positive results from a new study that evaluated DNA methylation-based marker panel for early diagnosis of nasopharyngeal carcinoma (NPC). The data appear in an online abstract as part of the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 31 to June 4, in Chicago.

"The changes in DNA methylation level commonly disrupt molecular signaling mechanisms and lead to the formation and progression of malignant tumors," said Dr. Dhruvajyoti Roy, LAM's Director of Technology. "The early detection of these changes can provide patients with the key advantage of time for a successful treatment."

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%).

Nasopharyngeal carcinoma (NPC) is the 3^rd most prevalent malignancy among men in Southern China and the 4^th 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 new data, presented in an online abstract, is available on the ASCO website at https://meetings.asco.org/am/abstracts.

About Laboratory for Advanced Medicine

LAM is a commercial-stage medical technology company focused on developing innovative, noninvasive, non-toxic technologies for the early diagnosis and intervention of cancers. The company is dedicated to building and growing world-class technologies from the laboratory to the clinic.

Headquartered in the United States with offices in California, Texas and Indiana, LAM has collaborations with leading scientists, physicians, research institutions and business leaders in the U.S. and China, combining their experiences to provide the most effective and safest diagnostic technologies to patients and their doctors. The company has CLIA-registered and CAP-accredited as well as third-party laboratories and cGMP facilities all working toward bringing first-class technologies to the medical community today.

SOURCE Laboratory for Advanced Medicine