Issue link: https://beckershealthcare.uberflip.com/i/1230114
55 GASTROENTEROLOGY The rise of Cologuard — Tracking Exact Sciences' journey By Eric Oliver E xact 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 market- ed 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 Colo- guard. November 2014: e American Cancer So- ciety 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-promo- tion agreement with Ironwood Pharmaceu- ticals 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 stand- ing 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 Informa- tion 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 Sten- house 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 mar- keting agreement for Cologuard. Exact CEO Kevin Conroy has pointed to this partner- ship as a driver of Exact's success to date. e completion figures that follow support that. October 2018: 241,000 tests completed dur- ing the quarter February 2019: 292,000 tests completed dur- ing 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 dur- ing 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 n Janssen affiliate helped grow GI practices in exchange for drug kickbacks, lawsuit says By Eric Oliver J ohnson & Johnson affiliate Janssen is accused of provid- ing free business advisory services to grow gastroenterol- ogy practices' infusion suites, which would then boost prescriptions of two Janssen drugs, according to a lawsuit filed in the U.S. District Court for the District of Massachusetts. What you should know: 1. The whistleblower complaint accused Janssen of giving away services that "carry significant value" and would nor- mally cost more than $1,200 per consultative session in ex- change for growing the drug lines of Remicade, a Crohn's disease drug, and Simponi, an ulcerative colitis drug. 2. The complaint alleged that Janssen "effectively be- comes a business partner … helping these practices es- tablish, operate and grow their infusion business so they continue using and buying Remicade and Simponi." 3. Janssen allegedly also provided similar services to rheumatology practices. These practices would also buy Remicade and Simponi. 4. The whistleblower lawsuit was originally filed in 2016. The U.S. Department of Justice and several state attorney offices declined to intervene. The lawsuit was reintroduced in April 2019 by the whistleblower, a for- mer employee. 5. Johnson & Johnson disclosed the reintroduced lawsuit in its annual 10-K filing Feb. 10. n