Exact Sciences' multitarget stool DNA test, Cologuard, is divisive. Touting 92 percent sensitivity and 87 percent specificity rates for detecting all stages of colorectal cancer, the test is heavily marketed and has seen significant growth recently.
Here are the company-reported quarterly testing numbers for Cologuard, rounded, along with notable events in Exact's history:
Oct. 9, 2014: Exact Sciences launches Cologuard.
November 2014: The American Cancer Society lists Cologuard in its Colorectal Cancer Prevention and Early Detection Guidelines.
February 2015: Exact announces more than 4,000 tests were completed in fiscal year 2014.
March 2015: Exact enters into a co-promotion agreement with Ironwood Pharmaceuticals to promote Cologuard.
May 2015: Nearly 11,000 tests completed in the first quarter of 2015
July 2015: More than 21,000 tests completed in the second quarter of 2015
October 2015: 34,000 tests completed in the third quarter of 2015
February 2016: 38,000 tests completed for the quarter; more than 104,000 completed in 2015
May 2016: 40,000 tests completed in the quarter
June 2016: Cologuard is included in U.S. Preventive Services Task Force 2016 CRC screening recommendations on equal standing with other screening tests
July 2016: 54,000 tests completed during the quarter
October 2016: 68,000 tests completed for the quarter; Cologuard is included in 2017 Healthcare Effectiveness Data and Information Set quality measures for CRC screening
February 2017: 82,000 tests completed for the quarter; 244,000 completed in 2016
April 2017: 100,000 tests completed for the quarter; Cologuard is included in Medicare Advantage Star Ratings.
July 2017: 135,000 tests completed in the quarter
October 2017: 161,000 tests completed in the quarter
November 2017: Exact announces plans to expand testing laboratory, headquarters in Madison, Wis.
January 2018: 176,000 tests completed in the quarter; 571,000 completed in 2017
February 2018: Exact surpasses 1 million completed tests
March 2018: Exact hires Paul Limburg, MD, as co-chief medical officer, and Mark Stenhouse as president of Cologuard
April 2018: 186,000 tests completed during the quarter
August 2018: 215,000 tests completed during the quarter; Exact and Pfizer enter into a marketing agreement for Cologuard. Exact CEO Kevin Conroy has pointed to this partnership as a driver of Exact's success to date. The completion figures that follow support that.
October 2018: 241,000 tests completed during the quarter
February 2019: 292,000 tests completed during the quarter; 934,000 completed in 2018. Exact surpasses 2 million completed tests.
April 2019: 334,000 tests completed during the quarter
June 2019: Exact opens a new laboratory in Madison to expand testing capabilities.
July 2019: 415,000 tests completed; Exact announces $2.8 billion Genomic Health acquisition
September 2019: Exact receives expanded FDA approval to screen patients between ages 45 and 49.
October 2019: 456,000 tests completed during the quarter; Exact launches a seven-year, 150,000-patient study to evaluate Cologuard
November 2019: Exact completes Genomic Health acquisition
February 2020: 477,000 tests completed in the quarter; 1.68 million in 2019