Exact Sciences’ ambitious plan to commercialize molecular diagnostic tests for several of the deadliest cancers is starting to come into focus.
Fresh off announcing a partnership with the University of Texas MD Anderson Cancer Center in Houston to co-develop multiple blood-based diagnostic tests for lung cancer, Madison, WI-based Exact (NASDAQ: [[ticker:EXAS]]) shared new details last week about planned molecular diagnostic tests for cancers of the pancreas and esophagus. Products targeting the latter two diseases will be developed with researchers at the Mayo Clinic, following the five-year extension in February of Exact’s research and development agreement with Rochester, MN-based Mayo—a pact that already yielded Cologuard, an FDA-approved, stool-based DNA test for colorectal cancer.
“We plan for Exact Sciences to be synonymous with the early detection of cancer, and we’re on our way to achieving this goal,” CEO Kevin Conroy said during a presentation Thursday in Madison, where the company gathered investors and financial analysts for an annual company update. (Disclosure: Exact Sciences is an Xconomy underwriter, but our coverage is determined independently by our editors.)
Still, bringing the pancreatic, esophageal, and lung cancer products to market could take more than five years and $400 million in research and development spending by Exact, according to early projections by financial analysts with Robert W. Baird & Co.
Let’s unpack the company’s roadmap for each cancer:
—Pancreatic: When someone gets diagnosed with cancer in the pancreas—a gland in the abdomen that plays a role in digestion and regulating blood sugar levels—it’s generally considered a death sentence. There are 49,000 new cases diagnosed and more than 40,000 deaths from pancreatic cancer each year in the U.S., according to American Cancer Society data. It’s the fourth-leading cancer killer in the U.S., but is projected to jump to second by 2030, Exact said.
The five-year survival rate is less than 5 percent for patients diagnosed after symptoms appear, Exact said. But some researchers believe that patients’ chances will improve if they are diagnosed before symptoms appear, when doctors can surgically remove some or all of the pancreas before the tumors grow too large and the cancer spreads.
“There’s a huge opportunity there, and there’s a big gap in the way we’re approaching this,” said David Ahlquist, a Mayo Clinic gastroenterologist who leads the research team developing the diagnostic products with Exact.
One problem is there are no reliable methods for catching pancreatic cancer early. Each year in the U.S., more than 600,000 pancreatic lesions are discovered incidentally through abdominal computed tomography (CT) or magnetic resonance imaging (MRI) scans. Most of those nodules or cysts turn out to be harmless, but subsequent biopsies do a poor job of sniffing out which “pre-cancerous lesions” are likely to morph into malignant tumors. Biopsies accurately identify nodules as cancerous somewhere between 50 and 75 percent of the time, while they only correctly identify pancreatic cysts as cancerous 30 percent of the time, according to data provided by Exact.
“Pancreatic cancer can be prevented, if you can select out which of these lesions warrant treatment,” Ahlquist said in a phone interview.
Exact plans to develop a test that would analyze juices secreted by the pancreas and search for DNA biomarkers associated with pancreatic cancer. The juices would be collected via an endoscopy exam—which involves sticking a tube down the throat—after an MRI or CT scan has discovered a potentially cancerous lesion in the pancreas. Such a test would also avoid some of the risks associated with a needle biopsy, which requires anesthesia and can cause fatal complications in rare cases, Exact said.
The key will be ensuring the test is accurate. In an early study by Mayo and Exact, a test scanning for four DNA biomarkers correctly identified pancreatic cancer 96 percent of the time, and had a false positive rate of just 3 percent. The final panel of biomarkers could change as Exact and Mayo researchers fine-tune the test and select the most predictive ones.
A 300-person clinical trial conducted by Mayo and sponsored by Exact is already underway. It will assess the accuracy of a panel of DNA biomarkers in detecting early-stage pancreatic cancer and high-grade dysplasia, the stage just before the tissue evolves into cancer. The study will look at pancreatic juice samples, as well as stool, blood, and cyst fluid samples.
The plan is to commercialize a pancreatic juice-based test first, then follow that up with a stool or blood-based test for detecting pancreatic cancer. The stool and blood tests have more market potential because they would be intended as a regular screening tool for a broader population, unlike the pancreatic juice test, which would only be employed after a lesion has been discovered through an abdominal scan. That also means the pancreatic juice test faces an easier pathway to FDA approval, Ahlquist said.
Still, the market opportunity for the pancreatic juice test is large—more than $500 million annually, Exact estimates.
—Esophageal: This disease is less prevalent than pancreatic cancer—roughly 17,000 new cases and more than 15,000 deaths per year in the U.S.—but Exact’s leaders think there’s an opportunity to improve detection methods, which they believe could help reduce the mortality rate. (Once symptoms appear, the five-year survival rate is less than 15 percent, Exact said.)
The company is devising a molecular diagnostic targeting patients who have been diagnosed with Barrett’s esophagus, a change in the lining of the lower esophagus that is associated with gastroesophageal reflux disease, a condition in which acid gets regurgitated from the stomach into the lower esophagus. People with Barrett’s esophagus are at increased risk of developing esophageal cancer, Exact said.
The problem is that
