Biomarkers demonstrate 95% sensitivity and 97.5% specificity in diagnosing hepatocellular carcinoma
IRVINE, Calif., Nov. 6, 2018 — Laboratory for Advanced Medicine (LAM), a commercial-stage medical technology company focused on developing innovative technologies for the early diagnosis of cancers, today announced new data further validating results from its completed clinical study on liver cancer demonstrating the ability of LAM’s novel DNA methylation-based biomarkers in detecting the presence of hepatocellular carcinoma (HCC) with 95% sensitivity and 97.5% specificity.
“The ability of our uniquely engineered platform to detect biomarkers of HCC, one of the leading causes of cancer mortality in the world, with such high rates of sensitivity and specificity is a testament to the influential work we are doing at LAM,” said Dr. Shu Li, LAM’s Chairman. “These data demonstrate a substantial improvement over current standard of care practices for HCC detection and support further development and expansion of our product pipeline to address unmet needs in cancer diagnostics.”
A total of 57 of the 60 samples drawn from subjects with hepatocellular carcinoma were correctly identified for an overall calculated sensitivity of 95%, with little difference between the sensitivity of detecting Stage I to Stage IV hepatocellular carcinoma (range 89% to 100%). Additionally, samples drawn from subjects without liver disease and those diagnosed with benign liver disease were correctly identified as non-cancer for a combined calculated specificity of 97.5%.
Of the samples drawn from subjects with cancer other than liver cancer, 90% of breast cancer samples, 80% of colorectal cancer samples and 90% of lung cancer samples were correctly identified as not liver cancer, for a total calculated analytical specificity of 87%.
For this study, banked samples were obtained for 130 subjects, including: 60 subjects diagnosed with hepatocellular carcinoma (Stage I to IV), 30 subjects without liver disease, 10 subjects diagnosed with benign liver disease and 30 subjects diagnosed with breast, colorectal or lung cancer. Samples were provided to the laboratory blinded for analysis. Cell-free DNA was then extracted from the samples, bisulfite converted, and DNA methylation was quantified by using the IvyGene Platform. After data collection and analysis of all samples was complete, the samples were unblinded to calculate test performance.
About Laboratory for Advanced Medicine
LAM is a commercial-stage medical technology company focused on developing 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.
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.