Posted on February 9, 2022
Last week President Biden issued a call to action on cancer screening as part of his newly relaunched Cancer Moonshot. New technologies for cancer screening, including tests to screen for multiple types of cancer, will likely play a significant role in cancer screening in the years ahead. In a white paper released today, NEHI recommends that the U.S. Food and Drug Administration collaborate with cancer stakeholder groups and adapt current methods for evaluation of medical devices to address the multi-faceted capabilities of multi-cancer early detection (MCED) tests intended for use in cancer screening.
MCED tests are an emerging class of innovative devices and analytical services that will detect many types of cancer based on the initial detection of blood-borne markers of cancer, such as cancer tumor DNA circulating in a patient’s blood. Many of these blood-borne biomarkers are common to more than one type of cancer, including cancers that are currently targets of routine screening (such as breast and colorectal cancers) and cancers not subject to routine screening, such as pancreatic cancer. (Only four of the thirteen most common cancers,as reported by the National Cancer Institute, are subject to routine screening.) MCED tests now in development are intended for use as complements to existing, single-cancer tests such as mammography and colonoscopy. Widespread use of MCED tests will depend in part on FDA approval based on favorable evaluation of MCED benefits and risks.
“President Biden is calling on the health care system to ‘jumpstart progress’ on cancer screening,” said Wendy Warring, NEHI President and CEO. “MCED testing could profoundly shift practices in cancer screening and diagnosis in the years ahead. NEHI’s white paper underscores the need for stakeholders to reach consensus on appropriate and responsible review of these important new devices.”
“The potential benefits of MCED testing are multi-faceted,” noted Tom Hubbard, NEHI's Vice President of Policy Research. MCED screening will detect types of cancer that often go undetected until the disease progresses to a later stage. The impact will be felt at two levels: the health of individual patients, and in public health, in which we may see an improvement in the overall detection of cancer.
Hubbard added, ”As with all medical testing, there is the possibility of incidental, adverse risks. A thoughtful approach to weighing benefits and risks is needed, particularly if MCED tests are to be approved for routine cancer screening of patients who otherwise do not appear to have any symptoms or family history of cancer.”
The NEHI white paper follows several months of research and consultation that began with an expert panel convened in the Fall of 2020 and continued dialogue into 2021. The panel included recognized authorities in oncology, biostatistics, clinical trial design, and medical device regulation, as well as representatives from two MCED test developers. The white paper released by NEHI today calls on stakeholders to acknowledge the need for an MCED-specific approach to the evaluation of MCED benefits and risks and work towards a consensus approach. Since MCED testing will generate test results for many types of cancer, some of which are not screened today and to which no pre-existing standards of accuracy apply, a fit-for-purpose approach is needed that can yield one, overall assessment of each MCED test seeking FDA approval. The effort should start with agreement on identifying major categories of benefit and risk that can be weighted in this overall assessment.
Tom Hubbard said, “Our white paper offers a categorization of potential benefits and risks of MCED testing, at both the individual patient and public health level. We recommend that the FDA and key stakeholders utilize this framework or a similar framework to enable a systematic evaluation of MCED use in the detection and clinical diagnosis of cancers, and the impact of MCED screening on persistent patient adherence to recommended modes of cancer screening.”
The NEHI white paper, “Multi-Cancer Early Detection Tests for Cancer Screening: A Call for Consensus on Benefit-Risk Assessment,” can be downloaded here.