What You Need to Know About the New FDA-Approved Colon Cancer Screening Test

Colon cancer is a severe health concern, but early detection can significantly improve treatment outcomes. According to the American Cancer Society, over 53,000 people will die of colorectal cancer this year.

That’s where the recent FDA approval of a new screening test for colon cancer comes into play. It's more than just another medical advancement; it could change the game for millions. The Food and Drug Administration approved Guardant Health’s blood test, Shield, for colon cancer screening.

While this test isn't intended to replace colonoscopies, it’s sparking excitement among doctors who believe it could dramatically improve screening rates for what remains the second deadliest cancer in the United States.

This is the second blood test to screen for colon cancer; Epigenomics’ Epi proColon was approved in 2016, but it’s rarely used.

What Are the Traditional Colon Cancer Screening Methods?

Colon Cancer is a severe disease and can be detected early through regular screenings, and there are several traditional methods that doctors commonly use to spot potential issues.

One of the most widely known is the colonoscopy; this procedure allows the doctor to detect and remove any abnormal growths, such as polyps, before they develop into cancer.

It’s often recommended for adults starting at age 45, especially for those with a family history of colon cancer. A further alternative for screening is sigmoidoscopy. Similar to a colonoscopy, a sigmoidoscopy looks into the sigmoid colon using a tube that has a camera on it. A sigmoidoscopy may miss polyps in the upper portion of the colon, although being less intrusive than a colonoscopy.

A fecal occult blood test is a less intrusive approach (FOBT). In order to do this test, the physician takes a stool sample and looks for evidence of blood. FOBT is capable of detecting colon bleeding, although it might not be able to pinpoint the source of the bleeding.

Frequent screening is essential. According to studies, the chance of dying from colon cancer can be lowered by as much as 68% with early identification using these conventional procedures.

Differences Between Shield the New Test and Traditional Colon Cancer Screening

Guardant’s Shield blood test promises a less invasive way to get screened for colorectal cancer. What makes it even more groundbreaking is that it could soon become the first blood test for colorectal cancer to receive approval for Medicare reimbursement. That would make it a lot more accessible for many people who might otherwise hesitate to get screened.

Right now, Guardant’s Shield test is already available as a lab-developed test (LDT), which means it can be used without needing FDA approval. However, if the test gets full FDA approval, it could open up even more access and be widely covered as a primary screening option.

This is huge because, while it wouldn’t replace traditional methods like colonoscopies, it offers a much less invasive alternative, having a simpler option like a blood test could encourage more people to go through with their screenings.

It is important to remember that blood tests like Shield don’t have the same capabilities as colonoscopies. For example, they can’t spot or remove polyps or lesions in the colon or rectum that might later turn into cancer. That’s where visual exams, like colonoscopies, so while the Shield test is a huge step forward, it won’t completely replace the need for traditional screenings.

The Shield blood test is aimed at people who are 45 and older and considered to be at average risk for colorectal cancer. However, it’s not meant for those who are at higher risk—people with a personal or family history of the disease, for instance.

The Process of Getting Shield Blood the New Colon Cancer Screening Test

Unlike traditional screening methods, no special preparations are needed. Patients don’t have to make any dietary changes, fast, or endure the uncomfortable preparation often required for colonoscopies. There’s no sedation involved, and you won’t have to take extra time off work or rearrange your schedule with family. It’s as simple as a routine blood draw.

During a regular office visit, your healthcare provider can have the Shield test ordered for you. A small blood sample is collected, just like in any standard blood test, and sent to the Guardant Health lab for analysis. The whole process is quick and minimally disruptive to your day. Since the test only requires a blood draw, it eliminates much of the inconvenience and anxiety that come with traditional colorectal cancer screenings.

Once the lab receives your sample, the results are usually available within two weeks. If the test comes back normal, no further action is needed. However, if the results show abnormal markers, your doctor may recommend a follow-up colonoscopy to take a closer look. The test works by detecting specific DNA markers shed by cancerous cells into the bloodstream.

For detailed information about the Shield blood test, a cutting-edge tool for colorectal cancer screening, including important safety guidelines, head over to ShieldCancerScreen.com. There, you’ll find everything you need to know about how Shield works, who it’s for, and how it can be a critical part of early detection.

When Insurance Companies Will Being Accepting Shield Blood Tests

The Shield blood test, approved by the FDA on July 26, 2024, marks an important advancement in colorectal cancer (CRC) screening. It’s currently the only FDA-approved blood test for CRC that is covered by Medicare.

For Medicare Part B and Fee for Service (FFS) patients, there are no out-of-pocket costs for the Shield test. However, those with Medicare Advantage plans may still have to deal with co-pays, deductibles, or co-insurance, depending on their specific coverage. Patients not covered by Medicare may need to pay for the test out of pocket.

When new medical tests like Shield come onto the market, a bunch of factors influence whether insurance providers will add them to their coverage.

One major factor is clinical evidence, insurers need solid scientific proof that a test is accurate and effective. As Shield continues to show it can catch cancer early and improve outcomes, this data could help make it more widely accepted.

Another key aspect of regulatory approval is that even with FDA approval, each insurance provider evaluates a test on its own. Some may wait for more data or input from other regulatory bodies before covering it.

Cost-effectiveness also plays a big role; all the insurance companies compare the costs of Shield with traditional screening methods. While Medicare has already recognized the value of Shield, broader insurance coverage will likely depend on continued clinical success, proven cost savings, and changes in healthcare policies.

Take Care About Your Colon Health

Over 75% of those who pass away from this disease have missed their screenings, so it’s crucial to stay on top of your health. Our team is committed to providing you with the best care and guidance to maintain your health and take proactive steps toward managing or preventing colon issues.