NEW YORK (GenomeWeb) – Shares of Exact Sciences rose as much as nearly 13 percent today after the American Cancer Society updated its colorectal cancer screening guidelines to recommend screening for people at average risk of the disease starting at age 45.
The society had previously recommended screening for people at average risk starting at age 50. The updated guidelines said that screening can be done either with a sensitive test that looks for cancer in a patient's stool, such as Exact Sciences' Cologuard test, or with a visual exam.
In a research note, William Blair analyst Brian Weinstein said that the recommendation is a qualified one, "meaning there is 'clear evidence of benefit (or harm) of screening but less certainty about the balance of benefits and harms or about patients' values and preferences, which could lead to different decisions about screening.'"
He also noted that the change follows recent data that suggests incidence rates for colorectal cancer in patients under the age of 50 have increased 51 percent since 1994.
Any positive impact to Exact Sciences stemming from the guideline change could take time to play out, Weinstein said, as the current label includes use of Cologuard for patients between ages 50 and 84 who are at average risk of colon cancer.
If the company were to try to change its label, it would likely need to conduct a separate, prospective clinical trial for the younger population. The trial size would need to be large enough to "demonstrate positivity levels in the 45-49 age group and prove that the molecular makeup of this cohort is identical to the 50-84 age group," an effort that would take time as the number of patients who are positive for colon cancer in the 45-49 age group is "still quite low," Weinstein added.
Leerink analyst Puneet Souda further said that the new ACS recommendation does not mean that the US Preventive Services Task Force and National Comprehensive Cancer Network will change their guidelines to lower the screening age for average-risk patients to 45.
"Still, ACS has a larger loudspeaker and the message is more likely than not to catalyze action at other guiding societies," such as the USPSTF and NCCN.
While he said ACS's action is "only directionally positive and unlikely to become reality in the near-term," Exact Sciences could also gain a larger share of the market than colonoscopy as a result of guideline change. "Cologuard is also likely to fit better in the busy working lifestyles of [the 25 million patients ages 45 to 49] vs a time-consuming colonoscopy," Souda said.
In early Wednesday afternoon trading on the Nasaq, Exact Sciences' were up 10 percent to $58.16.