FDA Expands Cologuard Cancer Test Approval to Younger People

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Most cases of colorectal cancer evade early detection

Exact Sciences announced  that the U.S. Food and Drug Administration (FDA) approved its noninvasive colorectal cancer screening test, Cologuard, for eligible average-risk individuals ages 45 years and older, expanding on its previous approval for ages 50 and older.

The label expansion will provide approximately 19 million potential customers for the Cologuard test and comes roughly 15 months after the American Cancer Society (ACS) updated it screening treatment guidelines in response to evidence of growing incidence rates of colorectal cancer in the 45-49 age group

“About three million people have been screened for colorectal cancer with Cologuard, with nearly half of those surveyed saying they were previously unscreened,” said Kevin Conroy, chairman and CEO of Exact Sciences, in a press release. “With the FDA now approving the use of Cologuard for this vulnerable 45-49 age group, we are giving health care providers a sensitive, noninvasive option that has the potential to help combat the rise of colorectal cancer rates among this younger group of people.”

According to ACS estimates, 145,000 people will be diagnosed with a form of colorectal cancer this year and will be responsible for more than 51,000 deaths. While the death rates per 100,000 people from the disease have been decreasing for both men and women over the past couple of decades due to improved treatments and earlier detection, there has been an increase of about 1% per year in deaths of people younger than 55.

Between 2004 and 2015, more than 130,000 cases of colorectal cancer were diagnosed in Americans under age 50. Among these cases, more than half were diagnosed at an advanced stage, stage III or stage IV, when survival rates are low. About one out of 10 people with stage IV colorectal cancer survive beyond five years.

“The alarming rise in incidences of colorectal cancer for those under 50 is creating a sense of urgency,” said Anjee Davis, president of Fight Colorectal Cancer, in a prepared statement. “To tackle the need for increased awareness and screening across the country, we must work together with advocacy groups, industry innovators, insurance companies and health care providers. There is a need to educate the public about colorectal cancer screening and the array of reliable screening options.”

Cologuard was approved by the FDA in 2014 as a screening tool for colorectal cancer and is also included in the ACS’s cancer screening guidelines. In addition, the test is a recommended option for adults over the age of 50 by the U.S. Preventive Services Task Force and National Comprehensive Cancer Network (NCCN).

In May of this year, Exact Sciences presented new findings that reinforce the utility of Cologuard as a colorectal cancer screening tool, showing high rates of compliance in the Medicare population while demonstrating that more than 90% of people who received the at-home test kit submitted samples within 60 days.

In addition, analysis of data from Mayo Clinic, showed that the majority of patients that received a positive Cologuard result completed the recommended diagnostic colonoscopy suggested by their test results. Of the patients who were found to have colorectal neoplasia at diagnostic colonoscopy, the proportion of right-sided lesions was higher in those with a history of prior colonoscopy compared to those who were new to screening, indicating that prior screening may have missed these right-sided lesions.

The company says that since its approval five years ago, the test has been ordered by 160,000 healthcare providers and has been used by more than 2.2 million people, with half of those tested self-reporting they had not been screened for colorectal cancer previously.

Based on Cologuard’s detection rates, Exact Sciences estimates the test may have helped detect as many as 10,000 early-stage cancers and approximately 70,000 pre-cancerous polyps.

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