29 October 2022
Hadley Barndollar, USA TODAY
At the risk of being seen as repetitive in my letters of the risk to health in the Solomon Islands by a yet non- introduced fully organised primary health care programme to facilitate screening and testing procedures to detect early signs of several diseases and life-threatening health conditions, I am sharing the following piece with the MHMS and with the people of the Solomons.
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A potentially revolutionary tool for public health in the United States, an emerging family of early cancer detection tests is targeting the nation's second-leading killer and the billions of dollars spent each year in its wake.
Cancer kills an estimated 600,000 people in the country annually, and in 2019, patients nationally spent about $29 billion associated with cancer care. President Joe Biden has made accelerating cancer research a hallmark of his presidency, and via his renewed Cancer Moonshot Initiative, set an ambitious goal to cut the U.S. cancer death rate by at least half over the next 25 years.
What might become critical to reaching Biden's goal are multi-cancer early detection tests, also known as MCED tests that experts are hailing as a possibly transformative, cutting-edge development.
These rapidly emerging tests are meant to complement existing cancer screenings by looking for multiple cancers at once and hopefully finding them early. But much research remains before the tests become part of mainstream conversation.
Dr. Timothy Rebbeck, a professor of cancer prevention at the Harvard T.H. Chan School of Public Health and Dana-Farber Cancer Institute, lauded the new technologies for their promise, but said MCED tests aren't a standalone or one-off, but rather a piece of larger, holistic cancer care.
"Prevention and early detection are going to have a much larger public health benefit than novel therapies, though we need all of those we can get, too," Rebbeck said. "If we really want to have a public health impact and save lives... MCED (tests) have a really huge potential impact."
One of the tests in initial stages of being prescribed by doctors is Galleri. GRAIL, the California biotech company behind it, calls the test a "new approach in the war on cancer," with the potential to "transform cancer care by reducing cancer deaths and decreasing health care costs by detecting more cancers earlier."
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"I think (the tests) are very promising for high-risk individuals," said Dr. Michael Hamrock, primary care physician at St. Elizabeth's Medical Center in Brighton, Massachusetts. "I envision once approved by the FDA and covered by insurance companies, it will someday be part of our regular screening tests."
Clinical studies have shown promising results — such as an ability to detect a shared cancer signal across more than 50 types of cancer and a false-positive rate of less than 1% — but experts emphasize that MCED tests remain in the early stages of development in terms of their implementation and proven outcomes.
Rebbeck cited "a lot of trial and error" right now around interpreting the tests and next steps of care following a positive result.
"You're not going to go from an MCED test to chemotherapy," he said. "A lot needs to happen before. There are so many other steps involved and we don't even really know what they all are yet."
And while MCED tests could revamp how the country catches cancer, the current price tag is a major barrier for access — $949 out-of-pocket for a Galleri test, for example. Since the tests are new and not yet approved by the Food and Drug Administration, insurance companies haven't started covering them.
A Massachusetts commercial health plan is the first in the nation to cover Galleri for its employees through a pilot program, with the goal of rolling out coverage for select members before year's end.
What is multi-cancer early detection?
Multi-cancer early detection is an emerging field of research focusing on tests that can identify a broad range of cancers early on. The demand is evident, shown by estimates that the global multi-cancer early detection market size will reach $2.77 billion by 2030, according to a new report by Grand View Research, Inc.
While most are blood-based "liquid biopsy” tests that capture bits of DNA shed by cancer cells into blood, some use urine, saliva or a stool sample to screen for multiple types of cancer. Despite not being cleared by the FDA, Galleri has been available for prescription by a doctor since 2021 under the Clinical Laboratory Improvement Act.
"Patients are very excited about the possible convenience of a test like this, and that's really important," said Dr. Lecia Sequist, director of the Center for Innovation in Early Cancer Detection at Massachusetts General Hospital. "It's also critical to find cancer at the earliest possible stage to have the best chance of curing it."
Regular screening is recommended for just five types of cancer — breast, cervical, colorectal, lung and prostate. For other types, screening isn't routine, meaning they're often detected in later stages after symptoms have emerged and the disease has metastasized.
At St. Elizabeth's Medical Center, Hamrock has used the Galleri test with Boston firefighters, a population at an elevated risk for cancer due to occupational exposure.
Targeted groups, accuracy: Many questions remain around MCED testing
At Massachusetts General Hospital, Sequist said they’re planning to launch a clinic focused on advising patients about early cancer detection tests; a trusted central repository where people can access the latest data.
"New experimental tests for cancer screening are being developed constantly," she said. "It’s an area of active investigation and some tests will be successful, while others may ultimately fail. It's in the early days."
Questions remain around who should be targeted for testing and how results should be interpreted. The Galleri test is advertised for people age 50 and older. Some experts say it should be reserved for high-risk individuals.
At the European Society for Medical Oncology Congress 2022, GRAIL announced the results of a study evaluating the Galleri test among more than 6,000 individuals age 50 or older. Corroborating a previously identified 1.1% cancer detection rate, 35 participants were diagnosed with 36 cancers. Among the confirmed cancers, 71% of participants had cancer types that have no routine cancer screening available and nearly half of the non-recurrent cancers were found in beginning stages.
Biden's Cancer Moonshot initiative, run by the National Cancer Institute, plans to enroll 24,000 patients ages 45 to 70 in a government-funded four-year pilot study starting in 2024 to look at how effective blood tests are in identifying cancer.
Boston’s Dana-Farber Cancer Institute is part of a consortium of public and private cancer-focused organizations evaluating the emerging multi-cancer detection technologies. In its initial report, the Multi-Cancer Early Detection Consortium wrote, "MCED tests will require careful evaluation of benefits, harms, and impact to ensure consistency with the principles of equitable and informed participation."
This article originally appeared on USA TODAY NETWORK.
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Yours sincerely
Frank Short
