New blood tests for multiple cancers gain political backing
1 of 2 | Flags stand as part of an instillation in support of more research, treatment options and funding for colorectal cancer on the National Mall in Washington, in March 2024. A push in Congress to provide coverage for new multi-cancer early detection tests under Medicare is gaining momentum, backers say. File Photo by Bonnie Cash/UPI | License Photo
As a new blood tests capable of detecting dozens of cancers in their early stages are hitting the market, disease prevention advocates say political and economic momentum is building for what they call a game-changing breakthrough in diagnostics.
Excitement over the potential of multi-cancer early detection tests, or MCEDs, has been growing since 2021, when GRAIL, a California-based medical technology start-up, first introduced Galleri, which it says can detect more than 50 types of cancer before symptoms appear — when they can be easier to treat and are potentially curable.
Another MCED product, this one developed by Exact Sciences of Madison, Wis., and called Cancerguard, was launched in September and is now conducting a national marketing campaign.
It’s also touted as capable of detecting 50 cancer types and subtypes in a single blood draw, including the ones considered most deadly such as pancreatic, ovarian, liver, esophageal, lung and stomach cancers.
While these tools have not yet been approved by the Food and Drug Administration, they are commercially available as “laboratory-developed tests,” a designation under which tests that provide accurate diagnoses on conditions for which no other options are available can be introduced into the market.
They are also costly and not covered by insurance — Cancerguard is priced at $689 per test, making it available only for those who can afford that sum out-of-pocket.
But because of the perceived potential of MCEDs to transform cancer prevention, the push to introduce them into the medical mainstream is gathering momentum. Healthcare companies, patient health advocates and U.S. lawmakers from across the political spectrum are seeking to make it happen.
For instance, a yearslong effort by a broad coalition of congressional lawmakers to pass a bill allowing MCEDs to be covered under Medicare once the tests gain FDA approval is closer than ever to success, according to backers.
The Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act, which has been deemed “the single most popular bill in all of Congress,” with 400 co-sponsors, passed the House Ways and Means committee in a unanimous 43-0 vote on Sept. 17, prompting lead author Rep. Terri Sewell, D-Ala., to declare the push has “strong, bipartisan momentum.”
Sewell named the measure after her late mother, who died of pancreatic cancer in 2021 at age 81. It passed the committee after representatives from hundreds of cancer advocacy groups flocked to Capitol Hill to “raise awareness of the urgent need for policies that improve cancer prevention, early detection, treatment and patient support,” the lawmaker said.
One of the most active groups backing the bill is the Prevent Cancer Foundation, whose chief executive says its considerable support is especially impressive because lawmakers know Medicare coverage of the tests will be costly, especially if they produce too many false positive readings that trigger unneeded “downstream” care.
“It’s a big deal to have that understanding of why expanding our abilities to screen is important, particularly when obviously there’s a price tag attached to it,” foundation CEO Jody Hoyas told UPI. “You have to pay for this kind of upstream care.
“The bill has been passed on both the House and the Senate sides and it is awaiting — despite overwhelmingly strong support — to be attached to a vehicle or some spending package. So we’re hoping that there’s still a chance this month, although I think that no one can predict what will happen with healthcare spending or any healthcare legislation. There’s a lot up in the air right now,” she cautioned.
The foundation, “along with many other advocates, are strongly messaging Congress that the time is now” as it considers a year-end healthcare spending package. Talks over such a package, however, have so far been dominated by partisan feuding over a possible extension of enhanced Affordable Care Act premium subsidies, which are set to expire Dec. 31.
The case for why Medicare coverage is needed is “very relatable,” Hoyas said. “The biggest risk factor for cancer is age. It’s important for the Medicare population to have broad screening coverage. We only have routine cancer screenings for five types of cancers right now and that means there are hundreds of cancer types that have no existing screening mechanism.”
It’s estimated that about 70% of all cancer cases are due to cancers without an existing screening, and despite the costs associated with covering the tests, “the unequivocable fact is that when a cancer is diagnosed earlier, treatment is less invasive and more successful, so that early detection equals better outcomes,” she said.
“It’s clear that it’s less costly to treat someone with an earlier cancer than to find out when it’s in the late stages and they’re presenting with symptoms.”
Meanwhile, the healthcare industry is also showing its enthusiasm for MCEDs by pouring major investments into the space.
For instance, just a month after Exact Sciences announced the launch of its Cancerguard test, the Wisconsin company was acquired by Chicago-based industry giant Abbott Laboratories in a $21 billion deal designed to “gain leadership in the fast-growing $60 billion U.S. cancer screening and precision oncology diagnostics segments.”
Exact Sciences was already well known in the field for its popular Cologuard product to non-invasively detect colorectal cancer, which like Cancerguard is a “liquid biopsy” tool that uses technology originally developed by the Mayo Clinic to detect DNA material in the bloodstream corresponding with the presence of cancerous tumors.
The company claims Cancerguard delivered 68% “sensitivity,” meaning the proportion of true positive tests, across six of the deadliest cancers, and 64% overall sensitivity across a broader range of cancers, excluding breast and prostate, in its development studies.
The test also found more than one-third of stage I or II cancers, demonstrating an ability to detect diseases when they’re most treatable, and posted a very high “specificity” — that is, accurately identifying “true negatives” — of 97.4%, thus helping to minimize false positives and so avoid costly unnecessary procedures.
When used alongside current screening methods, the company’s modeling shows that late-stage cancer diagnoses can be slashed by 42% and that overall cancer-related mortality could be cut by 18% over a 10-year span — potentially creating “a compelling impact,” according to Dr. Tom Beer, chief medical officer for multi-cancer early detection at Exact Sciences.
While improvements in screening for colorectal and some other types of cancers have proven to be quite effective in reducing mortality, “the fundamental challenge is that we only screen for a handful of common cancers, and nearly 70% of cancer diagnoses and cancer deaths are due to cancers that lack recommended screening options,” he told UPI.
“These include some of the deadliest cancers — like pancreatic, esophageal and ovarian. The Cancerguard test is designed to expand the reach of screening well beyond the four cancers we routinely screen for today to more than 50 cancer types and subtypes,” he said, predicting that the adoption of MCEDs generally “will mobilize enthusiasm for the potential of earlier detection.
“Exact Sciences is pioneering the future of cancer care. MCED tests represent an important shift in how we approach cancer early detection by broadening screening to more cancer types and helping move the country toward a future where reliable early diagnosis is accessible to everyone.”
To make MCEDs available at all income levels, Beer said the company supports the congressional push for Medicare coverage even as it continues to gather clinical evidence to make its case for eventual FDA approval.
“We believe it is an important step toward expanding access to early detection for more people,” he said. “We are encouraged that 400 members of Congress have signed on to support the bill, and we hope to see it cross the finish line, allowing more patients to have access to this innovative technology.”
In explaining the momentum that early detection cancer tests are now seeing, Hoyas of the Prevent Cancer Foundation said backers can foresee a time “when we think of cancer as a chronic disease instead of the currently pervasive perception that it is something of a death sentence. That’s huge in terms of addressing people’s fear of having a cancer diagnosis.”
The tests could alter the entire landscape of cancer research and drug discovery to focus more closely on treating and preventing the disease in its early stages and providing motivation across the biopharma industry to create drugs and therapies that are available to treat early cancers.
“The ability to have more people that can benefit from therapies and participate in trials would be a very powerful system change for how we approach cancer,” Hoyas said.