A safe and revolutionary multi-cancer early detection test is coming – here’s how we plan to make it happen

Cancer is detected too late.?Today, a staggering 70% of incident cancers have no routine early detection tests. As a result, most patients are diagnosed after they develop signs and symptoms of their disease. These “symptom-detected” cancers are often later stage and difficult to treat. Multi-cancer early detection (MCED) tests hold the promise to revolutionize the way we detect cancer and flip the paradigm to a world where the majority of patients have their cancer detected by a routine, non-invasive test rather than symptoms.

This past year, our company, Exact Sciences acquired Thrive Earlier Detection, the only company that has real-world data in an asymptomatic population to support the premise that we can find multiple types of cancer with a simple blood test. The groundbreaking results demonstrate we have the capabilities to move the needle from just 25% of cancers identified through standard of care screening to more than 50% identified with the addition of the blood test.[1] ?And patients’ lives have already been impacted in meaningful ways.

There is still work to do – work that must be driven first and foremost by scientific and regulatory rigor if we are to fundamentally change the way we detect cancer and enable earlier detection. Our company learned a lot about how important evidence generation is from our experiences with Cologuard?, our stool DNA-based test, to the eligible population. We are applying those learnings to other innovative early detection tests we bring to people.?

1.????Show the evidence and work closely with regulators throughout the process

When we needed to validate the science for our colorectal cancer screening test on a large scale, we worked with the FDA and CMS to design a 10,000-patient study for Cologuard to adhere to their rigorous standards of clinical evidence. As a result, Cologuard became the first test to be approved by both CMS and FDA on the same day through the agencies’ pilot program for a parallel review process. We helped create a new pathway with Cologuard and now with Thrive Earlier Detection, the company we acquired, we will together carve a novel regulatory and policy approach to advance a blood test designed to detect many cancers at earlier stages, to ensure that this test is done safely and that ultimately there is coverage to make it accessible to everyone.

2.????Partner to bring the best innovations from academic research labs into the hands of people

Exact Sciences partnered with Mayo Clinic to develop and bring Cologuard to the eligible screening population. The Mayo Clinic team shared our vision and values, and we were equally committed to delivering a screening test that would meet the urgent need, and was rooted in deep, thoroughly vetted science. Similarly, Thrive’s scientific founders are pioneers in cancer biology and earlier detection from Johns Hopkins University. Today, Thrive and Johns Hopkins continue to collaborate on advancing a multi-cancer early detection test. ?With the support of distinguished scientists, an expert R&D team, and our deep roots into two of the most storied institutions in cancer biology and technological innovation, we are laser focused on optimizing a safe, effective and accessible multi-cancer early detection test – and ensuring that health insurers cover the test so we can make it available to everyone.

3.????Build relationships and trust across a deep network of Primary Care Physicians

Our efforts around Cologuard taught us that engaging with primary care physicians requires introducing new innovations in a way that’s seamless and supports their daily work. A multi-cancer early detection test has the potential to offer a transformative approach to screening, that is complementary to some existing tests, which means we need to engage now with the healthcare provider community (physicians, nurses, care coordinators, etc.) to proactively seek and incorporate their input to help shape how these tests should be implemented. By working together, we will build the trust and the services they will need to support adoption.

4.????Put people first

A multi-cancer blood test should become a routine part of preventive care for everyone, making earlier detection of cancer a reality for significantly more people. Multi-cancer early detection tests will require a lot of upfront and ongoing education to ensure people understand how these test works, what they should expect following the result and the critical need to not forgo other screening methods. Cologuard taught us that we must provide meaningful patient support to minimize anxiety, and Exact Sciences’ expert patient support team is there to help people navigate the screening process. In addition to building a deep patient support network, we are also invested in building updated approaches to meet the needs of the innovations so we can continue to remove barriers to screening to give all people the greatest opportunity for earlier detection.

Just ten years ago, the late Dr. David Ahlquist, a Mayo Clinic gastroenterologist and the co-inventor of Cologuard, told me and the Exact Sciences team that our ultimate mission should be to create a test to screen for multiple cancers from one simple blood draw. It seemed like a dream, but he said we could make it a reality. ?Today, we are even closer to fulfilling this mission. More than 6 million people have been screened for colorectal cancer with Cologuard, so far, and we have heard thousands of stories of lives impacted by earlier detection. Now, we are taking the lessons learned from the complex process of bringing a screening test to millions of people and applying them to our multi-cancer early detection test, which has the potential to forever transform how we diagnose cancer and live longer and healthier lives.

[1] https://science.sciencemag.org/content/369/6499/eabb9601