The first steps came 19 years ago when
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
"These are tests that cannot be wrong," Conroy said.
Lidgard worked with Dr.
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
But that's less than it costs to bring a new drug to market. The average drug program in the U.S. now tops
Federal approval of Cologuard could have taken up to three years longer. Ordinarily, CMS, the
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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