A new screening test for colorectal cancer has far-reaching implications for Mayo Clinic, where the test was invented.
Cologuard, a product developed collaboratively with Exact Sciences Corp., alerts health providers to colorectal cancer's DNA and biomarkers.
Colorectal cancer is the second-leading cause of cancer deaths in the U.S.
Part of the reason for that is the squeamishness people have about getting colonoscopies — rectal exams that use cameras attached to probes.
Just descriptions of the exam are unsettling. You're under some sort of anesthesia, with your backside exposed while a bunch of techs and nurses and docs (okay, maybe it's only a few people but it seems like a bunch) try to lighten the mood by chatting about the Honkers, bass fishing or music.
If you remain conscious (which I did), the whole time, you're secretly hoping you don't toot.
The new screening test, likely available by prescription at Mayo in Rochester within a month, gets mailed to your house. You mail back a stool sample. The doctor gets results in about two weeks.
Yep, stool samples zipping back and forth across the country via the U.S. Postal Service.
Neither rain, nor sleet, nor hail, nor….
The hope of Mayo researchers is to make the process easy enough that most at-risk people will get screened — and treated early if cancer or its precursors exist.
A side benefit is that the millions of people who do get tested will each be paying a share toward Mayo's continuing research. The CEO of Exact Sciences said last week that the company's proposed Medicare charge is $502 per test kit.
Contrast that with what HealthBlueBook.com says is a "fair" price for a colonoscopy, including all costs; $1,632. You can basically cut that cost by two-thirds, skip the embarrassment of a health-provider-football-huddle around your backside and catch cancer and pre-cancer before it has a chance to spread.
Mayo will get an infusion of cash from intellectual property rights for inventing the test. That money will be in low-single-digits, percentage-wise, of the Exact Sciences fee.
If that turns out to be only $15 or so (3 percent), it adds up to a lot of money when you consider that more than 14 million colonoscopies were done in 2002, according to the National Institutes of Health. It's unlikely all of those will translate to at-home screening kits.
Yet, even if the Mayo- and Exact Sciences-developed test eventually grabs only half the market share, it could represent more than $100 million for Mayo's research programs annually.
The test was the first ever approved through a joint pilot program between the Food and Drug Administration and the Center for Medicare and Medicaid Services.
Both federal agencies approved Cologuard at the same time (although the CMMS approval is preliminary and requires a public comment period of 30 days prior to what will likely be formal approval).
That means money will soon begin to flow toward Mayo because patients will be eager to switch from colonscopies, Mayo in Rochester will be the first to offer prescriptions for the stool-test kits, Medicare will cover the test and insurance companies generally follow the lead of Medicare and cover the tests it covers.
The test only detects colorectal cancers. However, Mayo researchers said last week that several other cancers have already been shown to be detectable with similar methods. They are hopeful of developing home screening tests for early detection of esophageal, liver, pancreatic, bile duct, stomach and other cancers that currently have no screening tests.
If you or a loved one has been touched by one of these, you understand too well why this type of research is critical — and the importance of the flow of money to Mayo's research teams that will come from the colorectal-cancer screening tests.