It was a historical moment for the world of cancer screening as the FDA approves a blood test for colon cancer. This FDA approves colon cancer blood test as Shield, opens a new era in the early detection of one of the most common and deadly cancers. It’s allowing simple blood samples instead of a colonoscopy or stool based test.
What is the new FDA approved blood test for Colon Cancer?
In a historic decision, the U.S. Food and Drug Administration (FDA) has approved a new blood test to detect colon cancer, called Shield. The test was designed by Guardant Health. A blood test (liquid biopsy) looks for small pieces of tumor DNA that can be found in the bloodstreams of patients.
The new FDA approves blood test for colon cancer is for adults aged 45 and older who are at average risk of colorectal cancer. The FDA approves a new blood test to screen for colon cancer and provides doctors and patients with a new option for early detection of colorectal cancer without the pain and preparatory work of a colonoscopy.
How does the blood test for Colon Cancer work?
Based on studies showing that cancers release DNA fragments into the bloodstream, also referred as cell free DNA (cfDNA). The FDA approves a new blood test for colon cancer with the name of Shield. It looks for particular patterns in the cfDNA that could point to colorectal cancer. This is how it functions:
- A healthcare provider collects a tiny sample of blood.
- The sample is delivered to a specialized lab for analysis using cutting edge genomic technology.
- The sample will show whether there is any aberrant DNA linked to colon cancer.
- If the result is positive, the patient will be able to have a diagnostic colonoscopy to determine whether and where colon cancer is located.
Why was the blood test for Colon Cancer approved by the FDA?
The FDA approves new blood test for colon cancer screening has undergone many detailed clinical trial processes. The Shield test identified more than eight out of ten cases of colorectal cancer in a clinical trial, with an 83 percent sensitivity for the disease.
The colon cancer blood test FDA approval was based on evidence showing that the test met safety and requirements for patients. It offers an important option for patients who may not participate in screening at all.
A Major achievement in Cancer prevention
A blood test for colon cancer approved by fda could be a game changer for millions of adults who avoid traditional screening methods because of fear, discomfort, inconvenience or who avoid stool based tests for hygiene reasons. The FDA approval blood test for colon cancer could soon replace hesitation with action for millions of adults who put off colonoscopies for many reasons.
Who should take the Test?
Similar to some stool based screening options, the FDA approved blood test for colon cancer is for adults 45 years of age and older, who have an average risk of colorectal cancer like,
- No family or personal history of colorectal cancer
- Inflammatory bowel disease
- Genetic syndromes
If the test results are positive, a colonoscopy is required for confirmation.
Advantages of FDA approved Colon Cancer blood test:
- Convenience: The new blood test for colon cancer approved by the FDA is a simple blood sample, no bowel preparation, no anesthesia and no time away from work or life.
- Increased screening rates: Million of Americans do not get screened for colorectal cancer, but a simple blood test may increase participation rates.
- Early detection: FDA approved Colon cancer blood test will reduce the death rates by detecting cancer early.
- Accessibility: This will probably have the biggest impact on rural and marginalized populations because it can be conducted during routine clinical visits.
Limitations to be aware of:
FDA approval is exciting news, but it is important to know that the FDA approved colon cancer blood test is not meant to replace colonoscopy completely. It’s less sensitive in detecting precancerous polyps than colonoscopy or stool DNA tests. A positive test is always followed by a colonoscopy to confirm. False positives and negatives will occur just as with other screening tests. So, although the FDA-approved blood test for colon cancer is a great addition, it should be considered as one piece of a comprehensive screening strategy, not a substitute for it.
Impact on Public Health:
The FDA approval of this blood test for colon cancer screening is a huge public health victory. Colorectal cancer is the second leading cause of cancer deaths in the United States, but it’s one of the most preventable cancers when caught early with screening by introducing this new blood test for screening. Now healthcare systems may be able to see more patients, particularly who are avoidant of traditional colon cancer screenings that could be considered invasive. Following the introduction of this new test, there will likely be a greater focus on improving the national screening rates in colorectal cancer.
The future of Cancer screening:
Experts say that the FDA approved blood test is only the start of colon cancer detection. The National Cancer Institute funds initiatives to focus on blood tests that can detect other cancers such as lung, liver, and pancreatic cancer. We could see a significant change in the healthcare experience as we learn from the technology involved in screening through simple blood tests.
It might result in improvements in health industries with screens for several cancers with just a blood sample.
Conclusion:
The FDA approves colon cancer blood tests is an indication of a new and exciting era of preventive healthcare.
Shield, the first FDA approved blood test colon cancer detection, provides a simple, non-invasive, and effective approach to checking for disease.
A new blood test for colon cancer FDA approval, giving physicians and patients a new way to detect colon cancer early without having to undergo the discomfort and preparation required for a colonoscopy.
Frequently Asked Questions (FAQ’s)
1. What is the FDA approved blood test for colon cancer?
The blood test for colon cancer approved by the FDA, is known as Shield. It is a product of Guardant Health. It is a non-invasive blood-based screening test for catching DNA signals from cancer cells in the blood.
2. How does the new blood test for colon cancer work?
A test that will seek out tiny fragments of tumor DNA in the bloodstream of an individual. If there is detection of abnormal DNA patterns associated with colorectal cancer, then physicians would order a follow up colonoscopy for confirmation.
3. Who should undergo this blood test for colon cancer?
The FDA approved blood test is intended for adults older than 45 with an average risk of colorectal cancer.
4. How accurate is the FDA approved colon cancer blood test?
Clinical trials have identified approximately 83% of colorectal cancers. It will not identify all of them just like other screening tests.
5. Does the blood test replace colonoscopy?
No, FDA approves new blood test to screen for colon cancer and nothing else.
6. How often should one have a blood test?
Just like other screening tests, doctors recommend it every three years.
7. Will the blood test for colon cancer be covered by Medicare or insurance?
Medicare and private insurance companies are anticipated to begin covering as soon as the FDA approves it.
8. Why is this FDA approved blood test for colon cancer so significant?
It offers an easier choice for those who avoid getting colonoscopies.
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