With new medical research, medical 'tests' are springing up all over to test for genetic defects in unborn babies, best treatments for medical conditions, and risks of certain diseases, among other issues. The problem is not all these tests are accurate and are leading to unnecessary surgeries, putting patients on unneeded medications, and raising medical costs.
The problem is when tests are run at a single facility so the FDA is relying on manufacturer reported problems including deaths or injuries to patients.
"Diagnostic tests are now regulated differently depending on where they were developed and manufactured. Products that will be sold to multiple labs — “commercial test kits” — are typically subject to FDA review before they go on the market.
Manufacturers are supposed to inform the government if they learn that their products may have contributed to a death or a serious injury, and they may have to notify the government if they recall defective products.
But for tests manufactured and used within a single laboratory, the agency has not actively enforced regulatory requirements, even though doctors around the country may submit samples to that lab for testing."
The tests included here are the OncotypeDX for breast cancer recurrence risk and the CA-125 test for ovarian cancer. Using the CA-125 test as an example:
One blood test to help detect ovarian cancer was never shown to be effective, the report said, but was used anyway. False-positive tests may have led to “unnecessary surgery to remove healthy ovaries.”
According to the American Cancer Society:
"In studies of women at average risk of ovarian cancer, using TVUS and CA-125 for screening led to more testing and sometimes more surgeries, but did not lower the number of deaths caused by ovarian cancer. For that reason, no major medical or professional organization recommends the routine use of TVUS or the CA-125 blood test to screen for ovarian cancer."
There are also studies out looking at the validity of these two tests and others. The current administration as well as much of Congress is looking at ways to close loopholes and require additional testing and validation of the tests to ensure patients are not harmed or subject to unneeded treatments.
My doctors have never mentioned either of these two tests for me. I do not think they are used at the hospital where I am treated either. Sometimes I have wondered why these tests were not offered. But now I am happy I didn't make any decisions based on their results.