Cancer screening today is inconvenient and invasive: Two leading cancers, colon and breast, use screening technologies developed 50 years ago, leading The New York Times to label the colonoscopy, “the dreaded turning-50 test.”¹ As a result, these dated and uncomfortable cancer-screening technologies are on the decline.² ³
Yet, screening is critical. Cancer patients have a 90% chance of survival if cancer is detected at stage I versus only a 5% chance at stage IV4.
Over the past 10 years, the team of scientists at Laboratory for Advanced Medicine have used artificial intelligence and machine learning to identify unique and proprietary DNA signatures that predict the presence of cancer as early as stage I.
We are focused on developing simple, accurate, and customer-friendly tests that detect cancer early—all from a simple blood draw.
1Grady, Denise. The Dreaded Turning-50 Test. The New York Times. 2014 Mar 24.
2 CDC Newsroom. Colorectal cancer screening rates remain low. 2013 Nov 5.
3Miller, Jacqueline W., MD, et al. Breast Cancer Screening Among Adult Women – Behavioral Risk Factor Surveillance System, United States, 2010. CDC MMWR. 2012 Jun 15; 61: 46–50
4Cancer Research UK. Survival three times higher when cancer is diagnosed early. 2015 Aug 10.
“We are focused on developing simple, accurate, and customer-friendly tests that detect cancer early.”
–Ken Chahine, LAM CEO
Circulating tumor DNA methylation profiles enable early diagnosis, prognosis prediction, and screening for colorectal cancer
The detection of circulating tumor DNA in the blood is a noninvasive method that may help detect cancer at early stages if one knows the correct markers for evaluation. Here the authors analyzed methylation patterns in blood samples from multiple large cohorts of patients and identified and validated a methylation-based diagnostic score to help distinguish patients with colorectal cancer from healthy controls, as well as a prognostic score that correlated with patients’ survival.
Huiyan Luo, et al. Circulating tumor DNA methylation profiles enable early diagnosis, prognosis prediction, and screening for colorectal cancer. Science Translational Medicine. 2020 Jan 01: Vol. 12, Issue 524.
After evaluating the DNA methylation profiles for normal tissue and tumors from four common cancers (lung, breast, colon, and liver), the authors differentiated cancerous tissue from normal tissue with >95% accuracy. This demonstrates that methylation biomarkers can be used for the molecular characterization, diagnosis, and prognosis of cancer.
Hao, Xioke, et al. DNA methylation markers for diagnosis and prognosis of common cancers. PNAS. 2017 Jul 11; 114 (28): 7414–7419; first published June 26, 2017.
With a diagnostic tool based on an AI-system that utilizes transfer-learning techniques, the authors accurately classified images for macular degeneration and diabetic retinopathy and distinguished bacterial and viral pneumonia on chest x-rays. This diagnostic tool has incredible potential for more applications.
Kermany, Daniel S., et al. Identifying medical diagnoses and treatable diseases by image-based deep learning. Cell. 2018 Feb 22; 172 (5): 1122–1131
In comparing hepatocellular carcinoma (HCC) tissue and normal blood leukocytes, the authors found a high correlation between the methylation profiles of HCC tumor DNA and matched plasma circulating tumor DNA (ctDNA). The authors’ findings demonstrate an effective, blood-based method for the diagnosis and prognosis of HCC.
Ruihua Xu, et al. Circulating tumour DNA methylation markers for diagnosis and prognosis of hepatocellular carcinoma. Nature Materials. 2017 Oct 9; 16: 1155–1161.
- Detection of methylated circulating DNA as noninvasive biomarkers for breast cancer diagnosis
- Abnormal DNA methylation as a cell-free circulating DNA biomarker for colorectal cancer detection: A review of literature.
- Identification of methylation haplotype blocks aids in deconvolution of heterogeneous tissue samples and tumor tissue-of-origin mapping from plasma DNA.
- Accounting for tumor purity improves cancer subtype classification from DNA methylation data.
Laboratory for Advanced Medicine Clinical Research Programs
To gain regulatory approval to support our cancer test accuracy claims, Laboratory for Advanced Medicine is conducting extensive clinical study programs in the United States and China. Through collaborations with leading scientists, physicians, research institutions, and regulators worldwide, we aim to validate our products and provide the most effective diagnostic technologies to patients and doctors.
Clinical Trial for the Liver Cancer Test (CLiMB)
CLiMB is a clinical trial to detect liver cancer through the quantification of cfDNA methylation in blood samples.
- The trial is designed to evaluate the performance of our liver cancer test versus the standard of care today—an ultrasound test.
- The study will enroll approximately 1,600 participants ages 21 to 84 years with a diagnosis of liver cirrhosis and hepatitis and who are currently recommended for liver cancer screening every six months by ultrasound. This study is expected to be completed in 2020.
- The trial is designed to evaluate the performance of our liver cancer test against the performance of ultrasound and alpha-fetoprotein (AFP) test.
- The study will enroll approximately 1,000 participants with a diagnosis of primarily hepatitis. This study is expected to be completed by the first half of 2020.
LAM has patented its cfDNA methylation markers since 2014. The patents cover methylation markers, method of using methylation for early cancer detection, and our AI technology.