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the colon cancer screening and diagnostic market carefully to see what was needed. They talked to folks at the Mayo Clinic about another technology component they felt was necessary to combine with what Exact had. And they talked to their friends at the State of Wisconsin about getting some financial assistance to move the company from Boston to near their homes in Madison. Conroy and Arora joined on April 2, 2009, along with some help from a $1 million loan from the Wisconsin Department of Commerce.
Once on board, they went to work on a new plan. They wanted to come up with something far superior to the existing fecal immunochemical tests (FIT) that have been around for decades. Those tests look at stool samples for the presence of blood, which can sometimes indicate there’s a precancerous lesion in the colon, but it isn’t a highly reliable indicator. The existing FIT tests are cheap, in the $20 range, but various studies show they only detect about 65-75 percent of early cases of colon cancer and about 20-25 percent of precancerous polyps.
The vision at Exact was to come up with a test that looked at a combination of several gene mutations, alterations in DNA methylation (which affects how genes are expressed), as well as the presence of hemoglobin—a blood-based protein sometimes found in stool samples. If such a test could look for all those different things, it theoretically could catch many more cancers at an early, treatable stage. Exact’s management team felt they would have a noninvasive screening test that just might convince many more patients to get screened in the first place. Such a screening test would still need to be verified by a colonoscopy, but as long as it were highly accurate (in the 90 percent range), then it would certainly provide a compelling reason for a patient and physician to take that next step.
There’s a reason nobody else has come up with such a test yet—the technical challenges are daunting. Most of the DNA in a stool sample is from bacteria. There’s all sorts of human DNA normally getting shed in a healthy colon, which needs to be separated out from DNA that might be indicative of cancer. “It’s really a huge challenge to get the DNA extraction right, and knowing which DNA fragments and genes to look at,” Conroy said.
Once the new technology platform was put together for Cologuard, Exact went to work on crafting a clinical trial that could offer convincing enough proof to win over skeptical regulators at the FDA, skeptical physicians, and skeptical insurance companies who are all quite good at finding holes in sloppy, shoddy datasets. So Exact ran a few small case-control studies to get a sense, internally, of what it had. Then it spent the big bucks on a study called Deep-C, which enrolled more than 10,000 patients at 90 clinical sites in the U.S. and Canada. As a company trying to create a new kind of market where none had existed before, Exact knew it needed to go in armed for battle with strong clinical trial data that came with an FDA stamp of approval, even though it could have taken a shortcut by setting up what’s known as a CLIA lab that didn’t require prior FDA approval. Conroy didn’t say how much Exact spent on the Deep-C trial, but the company has invested $150 million in its development, he said.
“We felt (FDA approval) would be helpful in commercialization of the test, because more doctors would have confidence in it, and insurers would have confidence, as would the Medicare system,” Conroy said.
The study was designed for all patients to provide stool samples, and have them analyzed with Cologuard, with an existing fecal immunochemical test, and with a colonoscopy. By November 2012, enrollment was complete. Preliminary results came out six months later. The data showed that Exact hit all the study goals. Importantly, the screen was able to detect colon cancer in 92 percent of cases, and spot pre-cancerous polyps 42 percent of the time.
Exact is going over that data carefully now with the FDA, and with Medicare, in a set of parallel negotiations to secure market approval and reimbursement. The company hasn’t disclosed full details of the result just yet, preferring to put them out in a top peer-reviewed medical journal that it hopes will get the attention of a wide audience of physicians. Exact is preparing to make its detailed case for Cologuard in front of a public FDA advisory panel in early 2014, which it hopes will be followed by regulatory approval and Medicare reimbursement. If Medicare goes for it, Exact hopes private insurers will fall in line and pay for it as well, as they often do.
Exact has carefully prepared for this series of big events for years. The big clinical trial helped Exact set up a highly automated sample processing system at its Madison, WI facility, which Conroy says should be able to process up to 1 million samples per year at peak capacity. Exact is striving to deliver results back to patients and physicians with a turnaround time of one week. The company entered this year with 87 full-time employees, and has been making key hires this year as it prepares for the initial sales and marketing push behind Cologuard. This fall, Exact Sciences has made a number of hires on its commercial team from places like Cytyc, ARUP Laboratories, and Johnson & Johnson, said Peter Lawson, an analyst with Mizuho Securities, in a note to clients on Dec. 2. Investors now largely expect Exact to win FDA approval and secure reimbursement—the big question now is whether the company can successfully commercialize the test.
In a recent series of meetings with investors, Lawson wrote, “management walked through the two-pronged go-to market strategy; large healthcare systems but with the initial ramp driven by high prescribing fecal blood physicians, and the importance of patient engagement/compliance service to drive adoption.” While Exact has its fans on Wall Street, you can bet they will want to see sales picking up quickly after the first quarter on the market.
On his travels, Conroy said he sometimes get asked by investors why Exact is based in Madison. Isn’t it harder to recruit top-flight marketing people? Conroy, 48, who got an electrical engineering degree from Michigan State University and a law degree from the University of Michigan, said he brushes off such concerns.
“Madison is a great place to live, it’s a great place to start a company,” he said. “We have phenomenally talented scientists who are graduating every year from UW-Madison. Quality of life is really high. There are a lot of other biotech or life sciences startups in the area. Wisconsin is a great state to raise a family in, send your kids to school in. We’re in the middle of the country, and it’s easy for us to get to the West or East coast. I honestly wouldn’t want to be anywhere else with this business.”