Study Data Demonstrate High Sensitivity And Specificity Of IvyGene Test In The Diagnosis Of Liver, Breast And Colorectal Cancers
IRVINE, Calif., March 31, 2019 — 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 American Association for Cancer Research (AACR) Annual Meeting at the Georgia World Congress Center in Atlanta, Georgia. The data demonstrate LAM’s proprietary IvyGene Tests possess the ability to detect liver cancer with 95% sensitivity and 97.5% specificity, breast cancer with 89% sensitivity and 96% specificity and colorectal cancer with 93% sensitivity and 100% specificity.
“Early cancer detection is a key advantage for successful treatment,” said Dr. Shu Li, LAM’s Chairman. “Classic screening methods are invasive, costly and time-consuming whereas our tests only require a simple blood sample. Behind this simplicity is a complex technology, developed during years of research at LAM. The early detection of cancer is an unmet medical need, and we believe the potential benefits for society can be enormous.”
Three blinded validation studies were performed to evaluate individual panels of DNA methylation markers developed for the detection of liver, breast or colorectal cancers. By quantifying DNA methylation at the target sites, the cancer-specific markers were able to differentiate with high sensitivity and specificity subjects diagnosed with cancer from both healthy donors and subjects with benign diseases.
The results demonstrate the high diagnostic potential of cfDNA methylation markers isolated from blood for the detection of multiple cancers at various stages. In addition, a quantitative analysis of cfDNA methylation signature provides an opportunity for monitoring the disease. The benefits of a sensitive and specific assay to identify and monitor cancer is anticipated to aid disease management and ultimately, improve patient outcomes.
For more information, please see the abstract here.
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.