2021-07-01| Trials & Approvals

NHS To Trial GRAIL’s Blood Test That Can Accurately Detect Over 50 Cancers at Early Stages

by Sahana Shankar
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Cancer is on its way to becoming the leading cause of mortality as a result of extended lifespan, lifestyle choices, and risk factors in the environment. Most cancers can be completely cured or well managed if detected early.

Studies suggest that when detected at early stages, patients with skin or breast cancer make a full recovery and have comparable survival with the general population. While screening tests are available for some cancer types like breast and prostate, there is a wide spectrum of malignant cancers that are routinely diagnosed in later stages. Research has shown that an early diagnosis of cancer improves prognosis and survival and remains a major challenge in many cancer types.

A new study, published in Annals of Oncology, reports a multi-cancer early detection (MCED) test that can accurately detect over 50 types of cancer which can be effective as preliminary screening of high-risk individuals for early diagnosis.


Circulating Cell-free Genome Atlas

Previously, GRAIL Inc. established the Circulating Cell-free Genome Atlas(CCGA) study as a multi-center, large-scale clinical study to develop a blood test for cancer detection, based on whole genome sequencing of circulating free DNA (cfDNA).

In the second substudy, published in Annals of Oncology in March 2020, sequencing results from cancer patients coupled with machine learning were used to train the algorithm to identify methylation patterns in various cancers, to improve sensitivity and accuracy of identifying cancer signatures and predicting cancer origin.

The current study validated the test as a cancer screening tool by comparing clinical samples from cancer and non-cancer participants.


MCED Test Registers High Sensitivity and Specificity

With over 4000 participants (2823 with cancer and 1254 without cancer), the primary aim of this clinical trial was to test the sensitivity, specificity and overall accuracy of the diagnostic test to predict cancer based on cancer signal detection and prediction of cancer origin tissue.  Based on the methylation profiles at key genomic loci, the test had

  1. Specificity of 99.5% to detect cancer signal
  2. Sensitivity of 76% in the pre-specified group of 12 cancers
  3. Overall sensitivity of 40% for all cancers in stages I-III and 52% for stages I-IV. 
  4. Overall accuracy of 88.7% to predict cancer origin
  5. Average test positive rate of 51% in clinical samples

All participants in this study were over 60 years old. Cancer screening is recommended for people over 50 to mitigate risks and detect warning signs. Taken together, these results suggest that this single blood test, when coupled with other screening tests, can significantly improve the early detection of many cancers at a population level.

Dr. Eric Klein, primary author and chairman of the Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, USA, 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 study will continue to monitor the participants and collect additional information to ensure the suitability of the test as a screening tool for different populations. GRAIL has entered into a partnership with the National Health Service (NHS) in the UK to enroll more participants and further validate the test. The authors concede that this is a case-control study and may not behave similarly in the real world, more studies are underway to improve its performance and accuracy.

Related Article: A New Blood Test Aids in the Early Detection of Over 50 Cancers


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