Mayo Clinic announced today that it will become the first health-care organization to offer newly FDA-approved screening tests for colorectal cancer, the second-leading cancer killer in the U.S.
Cologuard involves testing stool samples with a kit at home, a procedure that's less invasive than a colonoscopy, the method generally used to look for the cancer.
Mayo researchers invented the process of screening stool samples for DNA and biomarkers. The test developed by Exact Sciences Corp. using Mayo research, becomes the first approved in a pilot program by both the Food and Drug Administration and the Centers for Medicare and Medicaid Services.
That means the test already is covered by Medicare.
Colonoscopies that screen for the catchable disease in the form of polyps require consuming liquid to trigger intestinal cleansing.The colonoscopy itself involves having aflexible, lighted tube inserted into the colon through the rectum to allow visual inspection.
Potentially cancerous polyps are removed when they're found, preventing them from becoming metastatic cancer.
Cologuard, the new prescription-requiring stool DNA test, was developed in a collaboration between Mayo researchers and Exact Sciences.
Exact Sciences stock has increased 15.6 percent in the past week, climbing from $15.61 last week, hitting $20.94 at mid-morning.
It's unclear what percentage of sales that Mayo will receive, but the test, according to Exact Sciences, is priced at $599. In a similar arrangement with another company several years ago, Mayo received 16 percent of sales.
"Cologuard represents a significant advancement in identifying colorectal cancer at its most treatable stage," Dr. Vijay Shah, chair of gastroenterology and hepatology at Mayo, said in Mayo's public announcement. "We believe offering this new tool will promote patient and community public health and may move more patients to get screened earlier — a critical step in beating this prevalent and preventable cancer."
An estimated 23 million Americans ages 50 to 75 do not get screened as recommended, according to Mayo.
Exact Sciences is expected to need a production facility to produce the kits, and Rochester may be in the running for it.
The Food and Drug Administration approved Cologuard this month.
Under the licensing agreement, Mayo co-inventor of the technology, Dr. David Ahlquist and Mayo Clinic, will "share in equity and royalties" from the tests.
Once Medicare covers a technology, drug or procedure, health insurers typically follow suit.
The test, according to Exact Sciences, "has been proven to find 92 percent of cancers and 69 percent of the most advanced precancerous polyps in average risk patients." It will be available for patients 50 and older.