• Will MCED tests minimize the need for single-cancer screenings?
• How will MCED fit into the current cancer screening recommendations?
• Are these tests available now?
• What is a Laboratory Developed Test?
• What are the challenges with MCED tests? 
• Are these tests covered by insurance?

Will MCED tests minimize the need for single-cancer screenings?

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.

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.

 Are these tests available now?

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.

What is a Laboratory Developed Test?

 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.

The FDA does not consider diagnostic devices to be LDTs if they are designed or manufactured completely, or partly, outside of the laboratory that offers and uses them.⁴

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)
• The risk of incidental findings through the initial blood test or follow-up diagnostics (e.g., identifying cancers or other medical conditions that would not cause harm)
• The accurate evaluation of the test without spectrum bias (e.g., studying the accuracy in populations with precancerous and benign lesions or other comorbidities)
• The need to develop a patient-centered framework for MCED tests that includes patient access, affordability, acceptance and accountability.

These challenges will require careful consideration and solutions to provide the greatest cost/benefit outcome of MCED tests to patients.

Are these tests covered by insurance?

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.