On Monday, Exact Sciences announced its noninvasive stool DNA colorectal cancer screening test Cologuard was included in the U.S. Preventative Services Task Force's recommendation statement for colorectal cancer screening.
Here are five things to know.
1. The USPSTF did not give Cologuard a specific rating. Exact Sciences' stock closed that Monday evening at $18.53 per share, but the Tuesday morning following the rating announcement the company's stock dropped to a 52-week low of $9.80, according to a Forbes report.
2. The Affordable Care Act mandates payers to cover treatments and services given an "A" or "B" rating by the USPSTF, according to Forbes. The agency also did not provide any guidance for when Cologuard should be used. "This decision was different than what I and most people had expected," said Kevin Conroy, Exact Sciences' CEO, according to Forbes.
3. CMS already covers Cologuard, but the USPSTF's preliminary decision muddies the waters for the company's future plans. Adoption of the test and private payer reimbursement are less certain. The agency's draft guidance has a 30-day public comment period; the final recommendations are expected in 2016.
4. Exact Sciences is already working with the USPSTF to change the test's rating, according to a genomeweb report. The company plans to provide the agency with more data on Cologuard during the comment period, open until Nov. 2.
5. Prior to the USPSTF decision, Exact Sciences predicted it would be able to achieve a 30 percent share of the CRC screening market, according to the genomeweb report.