How Exact Sciences plans to capitalize on the FDA's expanded indication — Cologuard President Mark Stenhouse explains 

Exact Sciences' week started with a boom when the FDA expanded its approval for the company's noninvasive colon cancer test Cologuard to include the 45 to 49 age range. 

Here, Cologuard President Mark Stenhouse elaborates on what the indication means to the company and how Exact will capitalize on the newly approved market of 19 million prospective patients. 

Note: Responses were edited for style and content. 

Question: How does Exact view this approval? 

Mark Stenhouse: We are proud to now offer average-risk people 45 years of age or older an additional screening option, Cologuard — a highly sensitive, noninvasive colorectal cancer screening option. CRC rates are rising among this younger age group. With a 51 percent increase in CRC incidence among adults younger than 50 from 1994 to 2014, we hope this accurate, at-home screening test will encourage people 45 to 49 years old to get screened. We are committed to helping win the war on cancer through early detection, and this approval brings us one step closer.

Q: How will the company mobilize Cologuard to reach the new market?

MS: There is a need to educate the public about reliable CRC screening options, and we encourage average-risk Americans 45 years of age and older to discuss these options with their healthcare providers. We are committed to working across the health care delivery system to ensure those seeking an at-home, noninvasive screening test have access to all options.

Q: Does the 45 to 49 age range look at colon cancer differently from the 50+ market? Will Exact change any of its marketing campaigns to reach this new audience?

MS: Those aged 45 to 49 years old are of particular concern because of the dramatic increase in CRC incidence observed in this age group. Currently, this age group is not regularly screened and sometimes symptoms do not [get screened] until the cancer has progressed to a later stage. Early detection is crucial because when CRC is detected in early stages, the five-year survival rate is 90 percent, compared to 14 percent if detected in late stages. The majority of adults younger than 50 diagnosed with CRC are presenting with a more advanced late-stage disease, which is less treatable. We're looking forward to reaching this group of people to help them take action and get screened.

Q: I believe the company pivoted to this age range based on the ACS guideline update, other U.S. societies have yet to lower their recommendation. Was this a proactive move by Exact? 

MS: The American Cancer Society judged the evidence sufficient to lower the screening age based on the disease-burden trends and modeling studies. When we learned of the new ACS guideline update, our team immediately took action, putting together our plans for the FDA label expansion. With incidence and mortality of CRC in people under 50 on the rise, it's critical to adopt screening methods to help reduce the impact of the disease for all ages and adjust common practices in a way that will head off this well-recognized trend in those under 50. We're incredibly proud to have FDA approval to provide Cologuard as an accurate, noninvasive, convenient method to help healthcare providers screen their 45- to 49-year-old average-risk patients. 

Q: Receiving this approval was also a milestone for Exact. What is the next large milestone Exact is working toward? 

MS: We are urgently working toward securing the same level of coverage that current Cologuard users 50 and over have in which more than 94 percent have no out-of-pocket costs.  Additionally, earlier this month, we announced that nearly 3 million people have been screened for CRC with Cologuard since FDA approval, with half of those tested who were surveyed being previously unscreened. Now that Cologuard is approved as a screening option for the vulnerable 45- to 49-year-old age group, we hope to continue to grow our impact on the eligible unscreened population, furthering our mission to detect cancer earlier.  

Do you have thoughts on Cologuard? Send them to Eric Oliver at eoliver@beckershealthcare.com

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