Exact Sciences says its next cancer test could begin studies in 2018
Exact Sciences Corp. gave a rosy report Tuesday on its finances for the second quarter of 2017, and said a major study on its second product in the pipeline — a test for lung cancer — will likely begin in early 2018.
The Madison company, whose Cologuard stool-based DNA test screens for colorectal cancer, said Tuesday revenue more than doubled and the number of completed tests increased 150 percent in the April-June quarter over the same period last year. As a result, Exact is raising its projections for the full 2017 fiscal year.
“As patient and physician demand for Cologuard continues to grow, momentum is increasing toward Cologuard becoming part of the standard of care in colon cancer screening,” said CEO and chairman Kevin Conroy.
Exact said it had a net loss of $30.8 million, or 27 cents a share, on $57.6 million in the second quarter compared with a net loss of $44.8 million, or 46 cents a share, on $21.2 million in revenue for the 2016 second quarter, in a report released after the stock markets closed.
The company said it processed about 135,000 Cologuard tests during the quarter, up from about 54,000 during the same quarter last year. Since the product received Food and Drug Administration clearance in August 2014, 81,000 health care providers have prescribed the test, including 11,000 new physicians during the second quarter of 2017.
Exact Sciences Corp. said it is raising projections for the year to revenue of $230 million to $240 million, from $195 million to $205 million. It now expects to process at least 550,000 tests during 2017, up from 470,000.
Exact is looking to start a third shift in its town of Madison processing lab and also expects to hire about 100 sales staffers during the third quarter, according to comments made during a conference call with financial analysts.
Company officials said they expect to be able to handle 1.5 million completed Cologuard tests a year within six months, up from 1 million a year now.
Conroy also said a test to determine if lung nodules are cancerous is the next product that will come from Exact’s “deep partnership” with the Mayo Clinic. He said the company will talk to the FDA late this year or early next year and expects to start a “pivotal study” to validate the screening test in the first half of 2018.
The goal is to show two things, he said: “that the new lung nodule test will help save lives and that it will save the health care system money.”
Conroy said the DNA biomarker technology used in Cologuard applies to many other types of cancer, providing “more opportunities ... than one company can pursue” in a short time span.
“We are changing the paradigm. We are excited about it. We are not going to stop,” he said.