Exact Sciences Corp. hasn’t finished building its second big laboratory building to process Cologuard tests for colorectal cancer but the Madison cancer diagnostics company already is planning for lab No. 3.
And, in an unrelated move, Exact’s stock price topped $100 per share this week for the first time.
Exact has “begun evaluating potential sites to open a new lab,” CEO and chairman Kevin Conroy told a conference call with financial analysts this week.
Conroy said the third site would be used for the company’s future products, all of which are still in research and development.
Company spokesman Scott Larrivee later declined to say what potential sites are under consideration or how quickly Exact wants to act on a third lab. Neither the city of Madison nor the Madison Region Economic Partnership is working with Exact on the project at this time.
Exact Sciences currently has one product, Cologuard, a kit for patients to use at home that screens for DNA biomarkers in stool. Approved for use by the U.S. Food and Drug Administration in 2014, it crossed the 2 million-patient mark during the first three months of 2019.
Use of the diagnostic test has grown more rapidly in the past year, and in 2019 alone, more than 1.5 million people are expected to use Cologuard, chief financial officer Jeffrey Elliott said.
Exact built an addition onto its first Cologuard processing lab on Badger Road and is expected to open its second lab, under construction off Schroeder Road, during the third quarter of 2019. When it’s operating, the company will have the capacity to handle 7 million Cologuard samples a year.
While that level may not be reached for a while, the company hopes to increase the pool of potential patients next year.
Exact Sciences has submitted an application with the FDA to extend approval for the use of Cologuard to people in the 45-to-49 age range, Conroy told analysts. The American Cancer Society last May recommended lowering the age from the current 50 and above to 45 and above. Conroy said he expects to hear back on that in the first half of 2020.
If approved, it would add 19 million people to the pool of average-risk adults who might choose to use Cologuard. Combined with the 87 million Americans age 50 and over who are of average risk, that raises the number of potential patients to 106 million.
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Conroy has said his eventual goal for Cologuard is to reach a 40 percent market share.
Partners with Mayo
Meanwhile, research with the Mayo Clinic — Exact’s partner on Cologuard — continues to move forward. The collaborators have identified biomarkers for 15 of the deadliest cancers, Conroy said, and some of the early results will be disclosed at an upcoming conference, including data on “a sizable study with the Mayo Clinic” on pancreatic cancer signals in blood.
The study is not a clinical trial related to pancreatic cancer, Larrivee said. Biomarkers are being identified “through archived samples” from Mayo Clinic, he said.
A blood test for liver cancer is expected to be the next product for Exact Sciences and Mayo. A clinical trial underway now aims to enroll 2,100 patients — up from the previous goal of 1,500. Seven-hundred people with diagnosed liver cancer will be tested as will 1,400 who are being closely watched for the possibility of developing the disease, in a trial expected to end in January 2020.
Stock has soared
Exact Sciences now has 2,300 employees, including 1,800 in the Madison area. At this time three years ago, in May 2016, Exact had a total of 750 employees, with 500 of them here, and had just cut 29 positions, including 12 in Madison.
Also this week, Exact Sciences’ stock, publicly traded on the Nasdaq market, inched over $100 for the first time, closing Thursday at $101.65 and Friday at $104.72. The Nasdaq market also hit a record high on Friday.
Analyst Brian Weinstein, with the William Blair & Co. investment firm, said he believes Exact’s message “is resonating with investors looking at what is a unique growth story.”
Last August, Exact Sciences stock hit its 12-month low point, at $47.78 a share.