News Column

Madison company put many pieces together to develop a new cancer test

August 31, 2014

By Judy Newman, The Wisconsin State Journal

Aug. 31--The road to developing Cologuard, a less onerous test for colorectal cancer than colonoscopy, has not been quick nor has it been easy.

The first steps came 19 years ago when Stan Lapidus started Exact Sciences in 1995 in the Boston area. Lapidus is a serial biotech entrepreneur and lecturer at MIT's Sloan School and Harvard Medical School whose accomplishments include pioneering new technology for Pap tests for cervical cancer.

Exact struggled after Lapidus left, and two early efforts to develop a colorectal cancer test faltered.

By 2009, the company was down to four employees. Lapidus recruited Kevin Conroy and Maneesh Arora, both of whom had been executives of Third Wave Technologies in Madison. They brought in Graham Lidgard, then head of research and development at Gen-Probe. Lidgard had developed tests to screen for HIV and hepatitis B and C in blood samples.

"These are tests that cannot be wrong," Conroy said.

Lidgard worked with Dr. David Ahlquist at Mayo Clinic to rethink the cancer screening tool. "We redeveloped the test from the ground up," Conroy said.

They came up with a way to extract 20 times as much DNA as before. They studied every known biomarker for colorectal cancer and tested them across variables such as age, obesity and smoking, then picked the four that performed best and obtained licenses to use them.

Then they screened 10,000 people to come up with at least 50 people with colorectal cancer.

"A trial of that size would normally take four to five years," Conroy said. It took Exact 18 months.

Arora ran the clinical trials and handled finances, operations and patents. "Maneesh kept all of the trains running on time," Conroy said.

Conroy brought in the money. In five and a half years, he met with 1,839 investors in the U.S. and Europe, and raised $411 million. So far, $200 million has been pumped into developing Cologuard.

But that's less than it costs to bring a new drug to market. The average drug program in the U.S. now tops $1 billion, Conroy said.

Federal approval of Cologuard could have taken up to three years longer. Ordinarily, CMS, the Centers for Medicare & Medicaid Services, won't look at a product until it's cleared by the Food & Drug Administration.

But Conroy met with officials of the two agencies back in 2009 to let them in on Exact's project. "They came up with the idea of a parallel review program," he said. "They invited us -- and we accepted."

In August, both agencies gave Cologuard the nod at the same time -- a historic first.


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Source: Wisconsin State Journal (Madison, WI)

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