No, MCED tests will not minimize the need for single-cancer screenings. The five single cancer screenings available today have demonstrated the impact of early detection in improving outcomes and saving lives. MCED tests are complementary to existing screenings.
Recommended single-cancer screenings will remain the primary screening for the cancers that have recommended screenings today.
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.
In the United States, clinical trials are underway. In addition, health systems, medical practices and self-insured employers may opt to offer MCED tests as a laboratory-developed test (LDT) prior to FDA approval. These blood tests would then be available by prescription only.
The National Health System (NHS) in England is piloting the use of an MCED test in 165,000 people between the ages of 50 and 79. Those who participate in the study will have a blood test each year for three years to check for the presence of malignant tumors.
A laboratory developed test (LDT) is a type of in vitro diagnostic (IVD) test that is designed, manufactured and used within a single laboratory.
While the uses of an LDT are often the same as the uses of FDA-approved in vitro diagnostic tests, some labs may choose to offer their own test. For example, a hospital lab may run its own vitamin D assay, even though there is an FDA-cleared test for vitamin D currently on the market.
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 :
These challenges will require careful consideration and solutions to provide the greatest cost/benefit outcome of MCED tests to patients.
MCED tests are not covered by insurance.
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.
In the absence of congressional action, it could take several years after FDA approval before Medicare beneficiaries can receive coverage for MCED tests.
4. Food and Drug Administration, White Oak, MD, https://www.fda.gov/medical-devices/in-vitro-diagnostics/laboratory-developed-tests, content current as of September 27, 2018.