New test proven to detect over 50 types of cancer
pharmafile | June 25, 2021 | News story | Medical Communications | Cancer. test, US, oncology
Final results from a study into a new blood test that can detect more than 50 types of cancer have shown that it is accurate enough to be rolled out as a multi-cancer early detection (MCED) test among people at higher risk of the disease, including patients aged 50 years or older, without symptoms.
In the paper that was published Annals of Oncology on Friday, researchers report that the test accurately detected cancer, often before any symptoms arose, while having a low false positive rate. The test also predicted where in the body the cancer is located with a high degree of accuracy, which could help doctors choose effective diagnostic tests.
The company developing and funding the research, Grail Inc., has now made the early detection test available in the USA by prescription only, to complement other existing screening methods such as those for breast, cervical, prostate, lung, and bowel cancers. Many of the cancers that the test is capable of detecting do not have screening tests available, such as liver, pancreatic and oesophageal cancers, which are among the most deadly.
Dr Eric Klein, first author of the paper and chairman of the Glickman Urological and Kidney Institute, said: “Finding cancer early, when treatment is more likely to be successful, is one of the most significant opportunities we have to reduce the burden of cancer. These data suggest that, if used alongside existing screening tests, the multi-cancer detection test could have a profound impact on how cancer is detected and, ultimately, on public health.”
The test takes blood samples from each patient and looks for cell-free DNA (cfDNA), which tumours shed into the blood. Genomic sequencing is used to detect chemical changes to the DNA called “methylation” that control gene expression, and a classifier developed with machine learning uses these results to detect abnormal methylation patterns that suggest cancer is present. In addition, the machine learning classifier can predict where in the body the cancer is located. Results are available within ten business days from the time the sample reaches the lab.
The Circulating Cell-free Genome Atlas (CCGA) study investigated the performance of the test in 2,823 people already diagnosed with cancer and 1,254 people without cancer. It detected cancer signals from more than 50 different types of cancer and found that across all four cancer stages (I, II, III, IV), the test correctly identified when cancer was present in 51.5% of cases. The test’s specificity was 99.5%, meaning that the test wrongly detected cancer in 0.5% of cases.
However, the sensitivity varied by type of cancer. In solid tumours that do not have any screening options, such as oesophageal, liver, and pancreatic cancers, overall sensitivity of the test was twice that for solid tumours that do have screening options, such as breast, bowel, cervical and prostate cancers: 65.6% compared to 33.7%. Overall sensitivity in cancers of the blood, such as lymphoma and myeloma, was 55.1%.
In addition, the test correctly identified the tissue in which the cancer was located in the body in 88.7% of cases.
Dr Klein said: “These data add to a growing body of literature that supports the use of next-generation sequencing for the detection of cell-free DNA in blood samples as a tool for earlier detection of common cancers that account for a significant number of deaths and other health problems worldwide. In addition, a screening test that requires only a simple blood draw could provide an option for communities that have poor access to medical facilities. I’m excited about the potential impact this approach will have on public health.”
Kat Jenkins
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