Dec 07

Laboratory for Advanced Medicine Announces New Data Demonstrating High Diagnostic Potential of DNA Methylation-Based Biomarkers for Early and Noninvasive Diagnosis of Breast Cancer at San Antonio Breast Cancer Symposium

Blood-based biomarkers demonstrate 89% sensitivity and 96% specificity in detecting breast cancer through IvyGene Test analysis
IRVINE, Calif., Dec. 7, 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 at the San Antonio Breast Cancer Symposium validating results from its discovery of biomarkers to accurately detect breast cancer. These data demonstrate the ability of LAM’s novel DNA methylation-based biomarkers to detect the presence of breast cancer with 89% sensitivity and 96% specificity.
“The ability to detect cancer in its earliest stages is an invaluable asset to all populations and LAM is proud that our proprietary technology enables individuals to do so noninvasively across several cancer types, including breast cancer, with such high levels of accuracy,” said Dr. Shu Li, LAM’s Chairman. “We recognize the significant role that DNA methylation plays in early cancer diagnosis and LAM will continue to utilize its advanced DNA sequencing methods to address unmet needs in cancer diagnostics.” A total of 53 of the 65 breast cancer samples were correctly identified for an overall calculated sensitivity of 89% with little difference between the sensitivity of detecting Stage I to Stage IV breast cancer (range 88% to 94%). Additionally, 37 of 39 samples drawn from healthy donor subjects (specificity 95%) and all 15 samples drawn from subjects diagnosed with benign breast disease (specificity 100%) were also correctly identified.
Of the samples drawn from subjects with cancer other than breast cancer, over 96% of lung cancer, colorectal cancer and liver cancer samples were correctly identified as not breast cancer.
For this study, 151 banked samples were obtained for a randomized blind study; 65 subjects diagnosed with breast cancer (Stage I to IV), 15 subjects with benign breast disease, 32 subjects diagnosed with other cancer types (11 colorectal, 9 liver and 12 lung cancer), and 39 healthy donor samples. Cell-free DNA was then extracted from the samples, bisulfite converted, and DNA methylation was quantified using the IvyGene Platform. The resulting raw data were collected and analyzed to evaluate the 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.
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