Through a partnership with Philadelphia-based Jefferson Health, Exact Sciences is creating a support framework for a blood-based cancer screening test in development.
“We’re trying to really understand behaviors, attitudes, and potentially fears about this kind of new test and technology before we actually launch it in the marketplace,” said David Harding, senior vice president of Thrive, a subsidiary of the Madison-based diagnostics company.
In a recent interview, he explained that rolling out a new test like this can cause “a lot of confusion” for both doctors and their patients. By simulating aspects of the testing and follow-up process with patients at the health system, the partnership aims to determine what kinds of educational materials, navigational aids and other support should be offered to supplement the test.
Patients that participate in the simulation will provide feedback through surveys, which Harding says will be used to understand how people are thinking and feeling about the process. He said this process aims to tap “a broad swathe of the population” served by Jefferson Health in parts of Pennsylvania and New Jersey, particularly individuals from underserved communities.
“We believe fundamentally that having a blood-based multi-cancer early detection test is going to be a great way to close some of the access gaps that we see in underserved populations,” Harding said. “We recognize that there are different patients with different experiences, and we want to make sure that we’re covering all the different segments of the population.”
The MCED test is still in the development phase. Harding says that process will be finalized “in the early part of 2022,” with an FDA study planned for the second half of next year. That study will run for several years, and Jefferson Health will be participating as a trial location, building on the existing partnership.
The test is meant for average-risk people approximately 50-90 years old. It’s designed to detect multiple types of cancer before symptoms occur to achieve better clinical outcomes. By combining the physical testing process with a machine learning system, the test will “improve with every person screened,” according to the company’s website.
Exact Sciences is also developing a service for interpreting results, coordinating follow-up testing and facilitating oncology care in the case of a positive test result. Unlike Cologuard, the Madison company’s at-home colon cancer screening test, the MCED test will require patients to get their blood drawn through their care provider or at a testing laboratory. Both tests can be obtained only after seeing a physician and getting a prescription, Harding said.
The FDA study starting next year will include a group of patients getting their blood drawn and receiving test results, along with a control group that will have their blood drawn but won’t receive results.
“So you can think about patients who are testing positive and what their journey would be, and those who test negative and how they get cycled back into the screening pool,” he said. “Ultimately what we’re trying to determine is, can we detect cancer earlier in various patient populations and are we improving on current standards of care?”
In the meantime, the planning and simulation process is underway at Jefferson Health’s primary care network, which includes more than 100 facilities serving more than 125,000 adults who are eligible for cancer screening. The effort is being supported by primary care doctors, population health scientists, administrators and others, including specialists at the Sidney Kimmel Cancer Center in Philadelphia.
See details on the MCED test here: https://www.exactsciences.com/innovative-science/the-pipeline/Multi-Cancer-Early-Detection
–By Alex Moe