Hundreds of thousands of Americans get screened for colon cancer each year. There are several screening options available including the traditional colonoscopy, a fecal immunochemical test and Exact Science’s Cologuard. The latter is classified as a “multitarget stool DNA test.” A recent study commissioned by Medicare revealed that Cologuard had limited effectiveness. That’s bad news for both taxpayers and patients.
Colon cancer, also known as colorectal cancer, is the second most common cause of cancer deaths in the United States. (Lung is the number one cancer killer.) Getting tested periodically, particularly if you are over 50, is critical in catching cancer early enough so that it can be successfully treated.
Each year approximately 130,000 new cases are detected. Despite this high number, colon cancer is usually preventable. Colorectal cancer can take up to 15 years to progress from a pre-cancerous lesion to full-blown cancer and death. Patients who are diagnosed early in the progression of the disease with pre-cancerous polyps or early-stage cancer are more likely to have a complete recovery and to be treated less expensively
If colon cancer can be detected, what is the best test?
As noted above, there are several methods approved by both the FDA and Medicare. Approval by the Centers for Medicare and Medicaid Services (CMS) is necessary if Medicare patients want coverage for the costs.
CMS approved Cologuard’s test in October 2014. For the average patient, Medicare will pay for the screening once every three years.
Recently the government asked MITRE corporation to do some studies on the various testing protocols. MITRE is a non profit research facility.
Exact Sciences’ Cologuard Fairs Poorly in Testing
Our read of the study is that Cologuard’s multitarget stool DNA test performed poorly. According to the report, Cologuard is “less effective and considerably more costly” than alternatives.
Exact Science, the maker of Cologuard, disputes those findings. They say the testing methodology was flawed.
According to the report,
“In the absence of screening, 64 per 1,000 65-year-olds will be diagnosed with colorectal cancer in their lifetimes… All screening strategies yielded large reductions in colorectal cancer incidence and mortality. Assuming 100% adherence, the reduction in lifetime risk of colorectal cancer with one of the established screening strategies ranged from 50% with annual FIT [fecal immunochemical test] screening to 73% with 10-yearly colonoscopy screening. With 46% colorectal cancer risk reduction, [Cologuard] testing was less effective.”
For all the science minded folks, the citation for the study is: Naber SK, Knudsen AB, Zauber AG, Rutter CM, Fischer SE, Pabiniak CJ, et al. (2019) Cost-effectiveness of a multitarget stool DNA test for colorectal cancer screening of Medicare beneficiaries. PLoS ONE 14(9): e0220234. There is a link above.
What does all of this mean?
Cologuard triennial testing is the most expensive. Medicare reimburses about $500 per test. While cost is a concern for patients, it is a larger concern for taxpayers. Why are we paying more for a test that is less accurate?
Expenses are a major concern for Medicare and hence taxpayers. Recently Cologuard completed their 2 millionth test. That over $ 1 billion of our tax dollars.
While cost is a concern, our major concern is patient safety. With 50,000 folks dying each year of colon cancer, we can all agree that the most effective testing method is in the public’s interest.
Assuming the MITRE study is accurate, why would anyone want the Cologuard test? The answer is simple, you can collect a stool sample at home, seal the sample and mail to the company for testing. The Cologuard test is a lot less intrusive than a colonoscopy. (“Pooping in a box” as one millennial calls it.)
Looking for an Exact Science Cologuard Whistleblower
Cologuard was required to be approved by the FDA before offering their test. Exact Science received its approval in August 2014. The Cologuard test required what the FDA calls Pre Market Approval. To receive such approval the company had to provide scientific evidence to demonstrate the test’s effectiveness.
According to our investigation, Exact Science told the FDA that its test had stellar performance:
• Cancer Sensitivity: 92%
• Stage I and II Cancer Sensitivity: 94%
• High-Grade Dysplasia Sensitivity: 69%
After reading the MITRE report, we are now questioning the testing process and whether Exact Science was completely transparent in its initial and on-going testing.
After the report was released, Exact Science’s stock dropped by 10% and the company immediately went on the defensive. Was the report wrong? Or did the company know its product was not very effective and is now engaged in damage control?
With the health of tens of thousands of patients on the line, this is a life and death issue for many people. The company only sees numbers but the actual people who have cancer that wasn’t detected by Cologuard are not numbers on a spreadsheet. They are someone’s mother or father or brother or sister.
We want to speak to Exact Science insiders who have information about any test results, studies or other relevant data hidden from the FDA. Because Cologuard is approved by Medicare, whistleblower rewards may be available.
Under the federal False Claims Act, whistleblowers can receive between 15% and 30% of whatever the government collects from wrongdoers. To qualify you must have inside information of the wrongdoing and generally be the first to report.
Reporting to a hotline does not qualify you for a reward. You must file a claim in federal court. (We can help!)
Signed a non-disclosure agreement? Those agreements generally don’t apply to reporting misconduct to the government. (We are happy to review a non-disclosure or severance agreement.)
To learn more about the whistleblower process, visit our Medicare fraud whistleblower information page. Ready to see if you a case? Contact us online, by email or call 202-800-9791. Services are available nationwide. All inquiries are protected by the attorney – client privilege and kept strictly confidential.
Cologuard Patient Where Test Failed to Detect Cancer?
No testing is 100% effective. Although a colonoscopy is the gold standard, many patients choose a less intrusive alternative. We have not concluded that Exact Science has liability for missed diagnoses. If it lied to the FDA, doctors and patients, however, our opinion may change.
Although the MITRE study greatly concerns us, we don’t know if there were flaws in Cologuard’s initial and any subsequent efficacy studies. We also have no evidence of a cover up either. At this time, we are not taking any patient cases nor do we know of other lawyers. Doing so.
We do maintain a list of names of potential claimants. We are happy to take your information however if you think you have a case, you should always seek active representation as many states have very short time periods to file lawsuits. Contact by email at .