How will MCED fit into the current cancer screening recommendations?

MCED tests are designed to be complementary to, not a replacement for, existing screenings, such as mammograms, colonoscopies and Pap tests. MCED can be administered alongside existing screening tests to increase the value of early detection visits. Recommended single-cancer screenings will remain the primary screening for the cancers that have recommended screenings today.

Are these tests available now and are they covered by insurance?

Different MCED tests are being developed and clinical trials are underway. Some tests are available now by prescription through a doctor. MCED tests are not covered by insurance. People who have this test will most likely have to pay for some or all of it out-of-pocket.

Under current law, Medicare coverage of preventive services is limited to tests for which Congress has explicitly authorized coverage. Private insurers cover screening tests that receive an “A” or “B” recommendation from the U.S. Preventive Services Task Force (USPSTF). The Task Force has not yet evaluated MCED tests.

How does genetic testing differ from MCED?

Genetic testing may be an option for those who want more information about their cancer risk. Predictive genetic testing is performed to look for specific changes, called mutations, in a person’s genes before they show signs of a disease. These tests are often done using blood samples, but may be performed using saliva or other tissues. Genetic tests do not detect the absence or presence of cancer. MCED tests use blood samples and are designed to identify the potential presence of cancer for more than one cancer at a time. If a person has a positive MCED test, additional follow-up testing is needed to determine if cancer is actually present.

What are the challenges with MCED tests?

Multi-cancer early detection tests are a new and innovative way of screening for cancer; as with any breakthrough technology, there are challenges that must be addressed before they can be utilized on a population level.

Some of these challenges:

• The sensitivity of the test for diagnosing each cancer included at an early stage
• The benefit of clinical intervention (without undue harm) at the time of diagnosis
• The impact to the patient of false positives and how this could vary depending on cancer type
• The ability and method to identify the tissue of origin (where the cancer started)