United States: According to the latest reports, the Food and Drug Administration (FDA) approved a new blood test to screen for colon cancer on Monday. The motive behind the test is to detect cancer at a much initial stage.
More about the finding
The blood test, known as Shield, is manufactured by Guardant Health and came into the market in 2022. However, it was not widely covered by private insurance companies.
Therefore, the patients had to pay the full USD 895 cost from their pocket, as the Hills reported.
Now that the FDA has approved the test, it will likely have increased coverage and access, although the cost will depend on individual plans.
What more has the Company stated?
According to the Company’s spokesperson, the self-pay price for the FDA-approved version of the test will be available within the next week once it is on a commercial scale.
Moreover, the company states that the Shield would be available for eligible individuals with a prescription through a doctor or other health providers. It is prescribed for people aged 45 and older with an “average risk” of colon cancer.
Colorectal cancer cases and tests
According to reports, Colorectal cancer is recorded as the second leading cause of cancer-related death in the United States. However, it is said to be treatable easily if recorded early.
As approved by the FDA as the first blood test, Shield would be taken as a foremost screening option for colorectal cancer, as explained by the manufacturer company.
Before the approval, the tests were taken as a complementary treatment option, not a replacement for the currently recommended screening methods, as the Hills reported.
Additionally, it has been approved as the first blood screening test for colorectal cancer, which meets the requirements for Medicare reimbursement. Moreover, once the coverage is decided, the eligible Medicare Part B beneficiaries will have no out-of-pocket cost.
What more are the experts saying?
As per the American Cancer Society, the five-year relative survival rate for colon cancer found at an early stage before it has spread is 91 percent.
Additionally, if the cancer has spread to farther parts of the body, then the five-year relative survival rate is just fourteen percent.
As per the latest guideline, screenings must begin at age 45. However, one in every third of eligible Americans, comprising fifty million individuals, do not follow screening instructions because of the presence of other available options like colonoscopy or stool-based tests, which are invasive, unpleasant, or inconvenient.
However, as per the company, the adherence rate for the Shield test has been more than ninety percent. On the other hand, the studies suggest that just 28 to 71 percent of patients prescribed other methods like colonoscopy or a stool test complete them.
According to William M. Grady, a gastroenterologist at Fred Hutchinson Cancer Center, “This is a promising step toward making more convenient tools available to detect colorectal cancer early while it is more easily treated,” as the Hills reported.