The blood-based liquid biopsy test analyzes the DNA methylation pattern of cell-free DNA (cfDNA) indicating the presence of hepatocellular carcinoma as early as Stage I
Irvine, CA /PRNewswire/ - Laboratory for Advanced Medicine (LAM), a commercial-stage medical technology company with innovative technologies for the early diagnosis of cancer, today announced that its Liver Cancer detection test has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA). The liquid biopsy blood test is designed to detect the presence of liver cancer, as early as Stage I, with high specificity and sensitivity.
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," said Shu Li, Ph.D., Laboratory for Advanced Medicine's Chairman and Chief Executive Officer. "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."
Laboratory for Advanced Medicine previously reported data from the preliminary clinical study of its cfDNA methylation-based biomarkers for the non-invasive detection of hepatocellular carcinoma (HCC) demonstrating 95% sensitivity and 97.5% specificity. The data was presented at The Society for Immunotherapy of Cancer (SITC) 33rd Annual Meeting in November 2018 and at 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," said Jinjie Hu, Laboratory for Advanced Medicine'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."
Coinciding with the "Breakthrough Device" designation, the company recently expanded its Hepatology Board with the addition of three distinguished medical doctors, including Robert G. Gish, M.D., Yujin Hoshida, M.D., Ph.D., and Ghassan K. Abou-Alfa, M.D., who was appointed Chair of the Hepatology Board. Additionally, Laboratory for Advanced Medicine 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, Laboratory for Advanced Medicine presented data showcasing the ability of its liquid biopsy test to diagnose breast cancer with high specificity (96%) and sensitivity (89%). A poster with positive results 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 on June 2019. Laboratory for Advanced Medicine presented data for the detection of NPC at the 2019 ASCO Annual Meeting, 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%).
About Laboratory for Advanced Medicine's Liver Cancer Test
The Liver Cancer detection test is a highly sensitive and specific blood test that has the potential to detect the presence of liver cancer, as early as Stage I. This blood test provides a highly accurate, non-invasive tool to the current standards of care. Liver cancer surveillance tests available on the market today do not offer a potent combination of high sensitivity and specificity. The 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 Liver Cancer test for a more accurate diagnosis of cancer presence and streamline the diagnosis process.
About the CLiMB Study
Subjects with a diagnosis of liver cirrhosis and who are currently recommended for hepatocellular carcinoma (HCC) screening every 6 months by ultrasound are being enrolled in the CLiMB trial during a routine HCC screening visit. Within the same clinical visit as the ultrasound, blood samples are being drawn for the Liver Cancer Test and to determine the concentration of blood analytes. Samples for the Liver Cancer Test will be collected using the Collection Kit, according to the instructions provided with each sample collection kit and shipped to the company's laboratory for processing and testing.
The anticipated study duration for most subjects is approximately 1 month to complete one round of HCC screening using the Liver Cancer Test, ultrasound, and diagnostic imaging.
For more information about the CLiMB trial, please visit: https://clinicaltrials.gov/ct2/show/NCT03694600
About Laboratory for Advanced Medicine
Laboratory for Advanced Medicine is a commercial-stage medical technology company focused on commercializing innovative, noninvasive, nontoxic 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.
Laboratory for Advanced Medicine is headquartered in the United States, with offices in California, Indiana and Texas. The company has collaborations with leading scientists, physicians, research institutions and business leaders worldwide, combining their experiences to provide the most effective and safest diagnostic technologies to patients and their doctors. Laboratory for Advanced Medicine has a 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.