Before cancers become deadly, signs of their presence can show up in escaped strands of DNA and other tell-tale molecules. Technical leaps are making it possible to find these signals in blood, saliva, urine and even exhaled breath. Now a consortium of leading cancer institutions and companies is setting out to pave the way for clinical use of the technology to screen healthy people for many kinds of cancer all at once.
“Multi-cancer early detection represents a paradigm shift in how cancers will be diagnosed and treated in the future,” a press release quotes Brian Druker, M.D., director of the OHSU Knight Cancer Institute, one of 11 organizations founding the Multi-Cancer Early Detection (MCED) consortium.
“By bringing together this group of experts from across the cancer research, clinical, and patient advocacy landscapes, we intend to evaluate evidence and establish standards for the emerging field of MCED that can guide physicians in adopting the technology in clinical practice,” Druker says. “Ultimately, we are united in our mission to evaluate how MCED may benefit patients by identifying their cancer at earlier stages, when they can be more effectively treated.”
Blood tests for multi-cancer early detection are closest to realization. GRAIL, Inc., is evaluating a blood test for its ability to detect more than 20 types of cancer (including types for which no screening methods exist) and predict tissue of tumor origin. A blood test developed by Thrive (acquired by Exact Sciences in January) was able to detect cancers arising from 9 different organs in a prospective study of 10,006 women with no prior history of cancer. Both companies are founding members of the new consortium.
In a forum in December 2020, participants helping to plan the consortium identified four core challenges:
- Defining the clinical utility, value, and efficacy of multi-cancer early detection tests.
- Equipping clinicians and health systems for the systematic changes in cancer care associated with multi-cancer early detection.
- Responding to the lack of adequate research investment in both early cancer detection and early cancer treatments.
- Concern about patient protections after the broad adoption of multi-cancer early detection.
In the 1990’s PSA screening became widespread and led to the overdiagnosis and harmful overtreatment of men who had non-life-threatening cancer. Participants recommended that MCED evidence receive careful consideration to proactively identify which populations and/or cancers will be helped by the technology. As one payer stated, “I would hate to relive the lessons of prostate cancer with this technology. When PSA screening came out, we all thought it was great—we penalized providers for not using it! As more evidence came out, we took away PSA screening and now we say there is value in the screen when it is used in a nuanced way.” Additionally, participants pointed to 23andMe, and its lack of clinical utility and guidance that left clinicians unprepared or unable to respond to results, as a reason to proactively educate clinicians on the technology and prepare them with clinically appropriate workflows. One said, “23andMe came out with great fanfare—but what were we supposed to do with these patients? It created a whole generation of really anxious patients and proved that using molecular tests to do mass screening can do harm. It was an abject disaster.” Moreover, as another participant noted, MCED is “different than anything we’ve experienced in the past—it is multi-cancer,” yet stakeholders are accustomed to exploring the value of cancer screens on a cancer-by-cancer basis. Participants agreed that having a consortium of leading relevant stakeholders would demonstrate to the broader medical community that leaders have “coalesced around the issues and been thoughtful in addressing them” and, as such, would help pave the way for a paradigm shift from single to multi-cancer detection.
The forum made clear the need for a public-private consortium dedicated to addressing the challenges of multi-cancer early detection. One participant spoke for many: “The science is fascinating and there is a real opportunity here. The question is how do we accelerate MCED so it improves patients’ lives and aligns with patient values?”
The following Q&A provided by the consortium gives some of the latest details about the effort:
Q. How did the Consortium come together? Which company/organization spearheaded its formation?
A. The Consortium was formed by a group of cancer experts – including clinical researchers, academic institutions, patient advocacy groups, healthcare provider organizations, payers, and private companies. Over the course of many conversations, these individuals and institutions, seeing potential for MCED technology to improve outcomes for patients with cancer, decided to come together to establish standards and guidance for the clinical introduction of these emerging technologies. Founding members are the Blue Cross and Blue Shield Association; Cancer Support Community; Dana Farber Cancer Institute; Friends of Cancer Research; GRAIL, Inc.; OHSU Knight Cancer Institute; Milken Institute; Stand Up To Cancer; Sarah Cannon Research Institute; and Thrive, an Exact Sciences Company.
Q. Do you expect that additional organizations and companies may join the Consortium?
A. Over 35 organizations have contributed to the formation of the Consortium today, and we anticipate welcoming additional founders to the group as we begin to chart our course forward.
Q. What is the purpose of the MCED Consortium? Why is this Consortium necessary?
A. Incorporating new technologies into medical practice can be a long and challenging process, which requires adopting standards for their use. The Consortium aims to evaluate the clinical and public health value of MCED tests in earlier treatment. It also aims to establish standards and guidelines for clinicians.
Q. Is this Consortium really just an effort for a private company to market a new technology? A. The Consortium was born out of conversations between cancer experts across a range of public and private organizations. The Consortium will be run by a third party.
Q. Who will be backing the Consortium’s work, financially?
A. Several funding models are being reviewed by the steering committee, that includes membership fees and charitable donations.
Q. Why are MCED technologies potentially beneficial to patients?
A. Currently in the US, there are only 5 cancers that are being screened for: breast, colon, cervical, lung in high-risk smokers, and prostate. When added to existing single cancer screening, MCED technologies provide an opportunity to identify a broad range of cancers earlier in the course of disease, potentially identifying cancer when it is still localized. Many 4 cancers are detected when they have already spread, making them more difficult to treat, and resulting in poor outcomes. MCED technologies may enable clinicians to treat cancers when they are still localized, when treatment is more likely to be successful.
Q. Which companies are developing early detection technologies?
A. Multiple companies have indicated the intention to evaluate early detection technologies, including Burning Rock; DELFI; Guardant Health; Singlera Genomics; Thrive, an Exact Sciences Company; GRAIL; and Freenome.
Q. What are the biggest challenges facing widespread adoption of MCED technologies?
A. Any time a new technology is introduced into standard medical practice, multiple challenges will be presented. This includes defining clinical utility, preparing new care pathways, and providing guidelines for clinical use, as well as a need to educate the public about the potential benefits of MCED. For this reason, the Consortium is focused on evaluating the clinical and public health value of MCED tests in earlier cancer detection and treatment and establishing standards and guidance for their use in routine medical care.
Q. How long before MCED technologies are widely available to patients?
A. It is expected that MCED technologies will begin to become commercially available later in 2021.