Blood DNA Test for Early Detection of Cancer Fails

Since the discovery of the DNA double helix in 1953, we have been told that gene tests for diagnosis and early detection of cancer were “just around the corner.” But the results of a major study in England testing that hypothesis using the Galleri Multi-Cancer Early Detection (MCED) test just failed miserably. 

In this study 142,000 healthy individuals age 50-77 conducted across the United Kingdom, patients underwent a Galleri blood test every year for 3 years. The intent was to detect early-stage (Stage I and II) cancer and provide earlier intervention before the cancers had spread. 

The reality has proven quite different. The test failed to detect early cancer, falling short of a 20% reduction of Stage III and IV cancers, the study design’s statistical endpoint. 

This is not surprising as a review of the Galleri DNA blood test’s sensitivity for detection in early-stage cancer has been known to be quite low, in the range of 15-20%. This has not prevented the company from selling the test to the public. 

Comments by specialists in the field have been harsh with one medical MD technology expert stating unequivocally “the study failed, end of story”

The lesson learned is that cancer is more complex than its genes. Indeed, genetic tests only provide a veneer of information regarding the complexity of human tumor biology. Regardless of the genes that you are given when you are born (your genotype) it is how your body uses those genes (your phenotype) that determines whether you will develop cancer. 

To better measure the human cancer “phenotypes” we developed a technique to examine how cancer cells make and use energy. By studying cancer metabolism (metabolomics) we can now identify signatures that define predisposition to cancer and provide information on the severity of the disease, as we have published in breast cancer, ovarian cancer, pancreatic cancer, and other diseases. It turns out that it is your metabolic signature that best defines your risk for cancer. 

Now 73 years since the discovery of the DNA double helix and hundreds of billions of dollars spent on cancer gene research, maybe the cancer research community will take a fresh look at cancer biology. But I wouldn’t hold my breath.

Cancer biology is many things, but simple isn’t one of them.