Breakthrough Cancer Technology Testing

You may have heard about new cancer detection tests working their way through the U.S. Food and Drug Administration’s (FDA) approval process that are expected to change the way we screen for cancer. There is a bill in front of Congress to shorten the length of time it takes for tests like these to be covered by Medicare – once approved by the FDA, so only the bureaucracy of Medicare approval would be improved. However, once Medicare approves this testing, it is more likely that private insurers will follow its lead.

Before you learn more about multi-cancer early detection (MCED) tests and the bill below, we want to share why VBCF is supportive of this bill. With our mission focused on breast cancer, which already has mammography, a good screening mechanism especially for the Medicare population, what effect would this have on our audience?

First, only 44% of female Medicare enrollees in Virginia get their annual mammogram, so getting screened through a regular blood test could help capture some of those who struggle to get a regular mammogram for whatever reason. However, where we really see the benefit in breast cancer is when these tests are eventually approved through private insurance and women under 40 (and men) can have access to them. Breast cancer can grow quickly in younger women, so being able to detect something perhaps before a lump can be felt or other symptoms arise could be a game-changer. 

And finally, mammograms are an effective screening tool, but they aren’t perfect. Pictures aren’t as clear for women with dense breasts and younger women (who generally have dense breasts overall) so cancer can get caught later or even missed until it has progressed to a later stage. Mammography machines are also expensive, and many of our rural communities don’t have regular access to them at their local hospital (if they even have a local hospital). VBCF is supportive of this bill because we see the path it creates for easier cancer detection down the line.

Cancer is the second leading cause of death globally, (number one in Virginia) and the American Cancer Society estimates that cancer will take the lives of more than 600,000 Americans this year alone (over 43,000 from breast cancer). Nobody has ever said, “thank goodness we caught my cancer late.” It’s not the way cancer treatment works. Identifying cancer earlier leads to better health outcomes for patients, but we often don’t catch enough cancers early enough. Today, only five (breast, prostate, lung, colon, and cervical) out of hundreds of cancers have recommended early detection screenings. That means nearly 75% cancer deaths are caused by cancers without available early screenings.

Multi-cancer early detection – or MCED – technology takes advantage of recent advances in the study of the human genome and uses computing power to identify multiple cancers through a single blood draw – which could be incorporated seamlessly into the blood work patients receive at regular checkups. By identifying cancers earlier, before the cancer can spread to other parts of the body, MCED can help improve treatment outcomes.

Through robust clinical trial programs, these technologies have shown their ability to identify many of the deadliest cancers before they metastasize.

The only problem is that it could take up to a decade or longer for Medicare to cover this new screening category unless Congress acts like it has consistently in the past for other cancer screenings. Luckily, a bipartisan group of forward-thinking legislators has introduced the Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021, which would modernize Medicare to help ensure coverage of this innovative technology for our most vulnerable.

VBCF is proud to join more than 300 leading cancer advocacy organizations across the country, urging Congress to pass this critical legislation. H.R. 1946 would allow Medicare beneficiaries to access MCED soon after the FDA has approved the tests currently in development. Since the signing of the National Cancer Act 50 years ago, MCED could be the breakthrough technology we have long sought. This innovative cancer detection technology gives us hope that we will find a way to beat this deadly disease so more patients can say “thank goodness we caught my cancer early.”

Learn more about the Medicare Multi-Cancer Early Detection Screening Act here. Join the conversation on social media using #earlydetection.

Update – January 2022: Since the writing of this blog, more opinions from leading voices in cancer research have come out with criticisms of multi-cancer early detection (MCED) tests or liquid biopsies as “not ready for prime time” (read FORCE’s opinion and an opinion published in STAT).

VBCF’s opinion is that while current tests might not be ready for widespread use, the time is coming, and our current Medicare system is not ready. When Medicare was created in 1968, the only real cancer screening test in existence was the pap smear for cervical cancer. Because of the lack of screening technology, the drafters of the program sought no need to require coverage of cancer screening and prevention through Medicare.

We now have five cancers that we can screen for, and it has literally required an act of Congress to get each of those screenings covered by Medicare. This process can take a decade, and that’s simply too long to wait to adopt new cancer tests.

This bill (S.1873/H.R.1946) does not make any judgments on the effectiveness of any MCED, that’s the Food & Drug Administration (FDA)’s job. What the bill does is enable a test to be covered by Medicare in the event it gets approved by the FDA. There are a few MCEDs in various stages of development and lots of clinical trials happening right now.

Once the science is ready for primetime, we want our healthcare payment system to be ready to roll these tests out to eligible patients.

Photo by National Cancer Institute on Unsplash.