FDA Grants Breakthrough Device Designation to Liquid Biopsy Liver Cancer Detection Test

Blood test

The U.S. Food and Drug Administration (FDA) has granted a Breakthrough Device designation to a Liquid Biopsy Liver Cancer Detection Test being developed by Laboratory for Advanced Medicine (LAM), a commercial-stage medical technology company.

The blood-based liquid biopsy test analyzes the DNA methylation pattern of cell-free DNA (cfDNA) indicating the presence of hepatocellular carcinoma (HCC; liver cancer) as early as Stage I.

“Changes in DNA methylation level commonly disrupt molecular signaling mechanisms and lead to the formation and progression of malignant tumors,” explained Dhruvajyoti Roy, Ph.D, LAM’s Director of Technology.

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

Highly accurate
The liver test provides a highly accurate, non-invasive tool to the current standards of care. Liver cancer surveillance tests available today do not offer a potent combination of high sensitivity and specificity. LAM’s liver cancer test provides patients with cirrhosis a great tool to detect the presence of liver cancer before it becomes life-threatening. With a low false negative and false positive rate, patients and physicians may rely on the test for a more accurate diagnosis of cancer presence and streamline the diagnosis process.

The FDA grants breakthrough designation to devices that have the potential to provide for more effective diagnosis of life-threatening diseases such as cancer. The agency’s Breakthrough Devices program speeds up development, assessment and review to provide patients and their doctors with quicker access to medical devices.

“The FDA’s recognition of the liquid biopsy test’s potential for the early detection of liver cancer represents a significant milestone for the company,” noted Shu Li, Ph.D., Chairman and Chief Executive Officer of Laboratory for Advanced Medicine.

“The ability to accurately detect cancer from a blood draw holds immense promise for improving the diagnosis, prognosis and monitoring of cancer. Testing for and detecting cancer earlier, even before symptoms arise, enables physicians to treat earlier and smarter, improving patient chances of survival and reducing the cost associated with treatment,” Li noted.

Clinical study
Previously reported data from the preliminary clinical study of LAM’s cfDNA methylation-based biomarkers for the non-invasive detection of hepatocellular carcinoma demonstrating 95% sensitivity and 97.5% specificity. The data was presented at during the 33rd Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in November 2018 and during the American Association for Cancer Research (AACR) Annual Meeting in March 2019.

“This non-invasive way of uncovering the earliest signs of malignancy is attractive to both providers of healthcare services and patients alike,” explained Jinjie Hu, the company’s Chief Regulatory Officer.

“With over 700,000 patients who are at increased risk for liver cancer in the United States and a 15-fold increase in 5-year survival rates when the cancer is detected at early stages versus late stages, we are honored by the FDA’s recognition and look forward to bringing this technology to the market,” Hu added.

Broadening Pipeline
In addition to LAM’s Liquid Biopsy Liver Cancer Detection Test, the company is broadening its offering of proprietary, highly accurate, methylation-based blood tests. Its pipeline includes tests for the early detection of breast cancer, colorectal cancer, lung cancer and nasopharyngeal carcinoma (NPC). The company’s researchers are also working to discover highly accurate biomarkers for brain, ovarian and pancreatic cancers.

At the San Antonio Breast Cancer Symposium (SABCS) in December 2018, LAM’s scientists presented data showcasing the ability of the comapny’s liquid biopsy test to diagnose breast cancer with high specificity (96%) and sensitivity (89%).

The data demonstrating the diagnostic potential of cfDNA methylation markers for the detection of colorectal cancer as early as Stage I (100% specificity and 93% sensitivity) was also presented at the 2018 SITC Annual Meeting as well as at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2019.

Nasopharyngeal carcinoma
Earlier this year LAM presented data for the detection of NPC at the Annual Meeting of the American Society of Clinical Oncology (ASCO), including data on the ability of its liquid biopsy test to confirm the presence of tumor cells as early as Stage I, with little difference between the sensitivity of detecting Stage I to Stage IV NPC (range 92% to 100%).

The data from this study validated and demonstrated 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.

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.

Clinical research
Clinical Trial for the IvyGene Liver Cancer Test (CLiMB) – NCT03694600

Reference
[1] Liquid Biopsy Platform Demonstrates High Diagnostic Capabilities In Early Stages of Nasopharyngeal Carcinoma. Onco’Zine May 31, 2019 Online.  Last accessed September 4, 2019.