Exact Sciences’ biggest priority after Cologuard is lung cancer test

Exact Sciences CFO Jeff Elliott says the foundation laid with Cologuard will help bring to market other screening tools, such as a lung cancer test.

Elliott gave a promising update on Cologuard and laid out the Madison-based company’s plans at a recent Wisconsin Technology Council luncheon in Madison.

Exact Sciences’ noninvasive Cologuard test screens for colon cancer, one of the most deadly forms of cancer.

“Cologuard is really the first product in what we see as a series of diagnostics,” Elliott said.

He says the company has been working with the Mayo Clinic for the past five years, exploring other cancers which could be screened for using blood tests. Though he says there are over 40 potential products in the pipeline aimed at 15 different cancers, a lung nodule test is the company’s biggest priority after Cologuard.

“About 1.5 million times a year, doctors and patients have to answer the question: ‘What is that white dot?’ … There’s a 95 percent chance that it’s nothing, but a 5 percent chance that it’s lung cancer,” Elliott said.

He says for the majority of those cases where a scan turns up something questionable, doctors tell potentially worry-stricken patients to go home and come back in a year. For about 20 percent of cases, the patient undergoes a procedure where a long needle is inserted in between the ribs in an attempt to sample the nodule. Elliott says about 20 percent of those who get the needle procedure experience a collapsed lung.

“We think a better opportunity, a better test would be at the time you diagnose that nodule to do a blood draw… to see if that nodule is cancer or benign,” he said. “What we see is a market opportunity between $750 [million] and $1.5 billion — this is a highly motivated doctor/patient population.”

In tests with the Mayo Clinic, early versions of this lung cancer diagnostic have been encouraging, Elliott says. About 400 samples were tested. The samples included nearly 90 cancers across all stages and subtypes of cancer, and were compared to about 300 controls, which came from “otherwise healthy” smokers.

“In this sample, we showed over 90 percent accuracy at discriminating a benign nodule from cancer. This data is very promising,” he said. “Our plan is now to meet with the FDA in the coming quarters — if that meeting goes well, then we will initiate the pivotal study which will take about two years, and then another year or two after that we will hopefully bring that product to market.”

And, he added, this would be “the first of many” new diagnostic products.

Though Exact Sciences is looking ahead to future opportunities, Elliott says the main focus is on Cologuard, which is steadily gaining ground in the market.

“In the last quarter which we just reported a few weeks ago, we completed 161,000 tests in one quarter,” he said. “You think back to 2014, we completed 4,000 tests — so we’ve come a long ways.”

Elliott chalks up much of that success to a national cable TV advertising campaign featuring “Little CG,” an animated version of the company’s Cologuard test box. The campaign has been running for the past 18 months.

“In the quarter before Little CG took to the airways, we grew by 2,000 tests. In the six quarters since then, we’ve grown by 20,000 tests on average each quarter, so he has made a huge difference,” he said, adding that the expanded sales force has also made an impact.

In the past three years, over 91,000 doctors and nurses have ordered Cologuard. That means it’s reached about 25 percent of all primary care physicians in the country, Elliott says.

And since the TV campaign began, about 800 new doctors place an order every week for their first Cologuard test. Elliott notes that 90 percent of those orders come from those who had not previously been contacted by the company’s sales force.

“That shows the power of TV advertising,” he added.

And though the company is still operating at a loss, Elliott says “we are very confident that we will get to profitability.”

“We think that if we try to rush towards profitability, we’ll shortchange patients, we’ll shortchange the community, we’ll shortchange investors,” he said. “So we’re investing for the longer term.”

–By Alex Moe