This month, the FDA gave “Breakthrough Device Designation” to a new blood test by Guardian Health for detection of eight tumor types: colorectal, lung, liver, pancreatic, ovarian, esophageal, gastric and bladder. The test detects what is known as circulating tumor DNA, that is, pieces of DNA from dead cancer cells that can be found in the blood. Like all breakthroughs, there’s good and bad news.

The good news:

  1. If the test was positive, it was remarkably accurate in identifying the origin of the tumor. Accuracy of this was 90% meaning that in nine out of 10 cases it correctly identified the organ where the detected cancer was located. This is most important as it makes finding the hidden cancer much easier.
  2. The sensitivity of the test, i.e. actually finding a cancer, ranged from as high as 95% for liver cancer down to 62% for bladder cancer. The other cancers detected fell between these ranges.
  3. A negative test was extremely accurate (99%) in predicting no cancer present.

The bad news:

  1. The test is not available as yet to the general public. Average time for such a test to become available with full FDA approval is approximately 300 days. Hopefully, it will be even quicker.
  2. The detection rate for early stage 1 cancer, when it’s most treatable, is only around 50%.
  3. It will not detect pre-cancerous lesions such as colon polyps.
  4. Cost is not yet determined, but I doubt it will be cheap. However, compared to the cost of treating a late-stage cancer, it will be a bargain.

For now, don’t forget that routine doctor visits and approved screening tests, such as mammograms, stool for blood tests, skin surveys and colonoscopy are available and accurate, but only if you use them.

Dr. Charlie Barnett is a contributor at KnoxTNToday for a weekly column, DocTalk, providing his expertise on health and wellness management.

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