Less than a year after Exact Sciences secured FDA approval and Medicare coverage for a colon cancer diagnostic, Cologuard, the company has set its sights on its next challenge: early detection of lung cancer.
Madison, WI-based Exact (NASDAQ: EXAS) this morning announced a partnership with the University of Texas MD Anderson Cancer Center in Houston to co-develop multiple blood-based diagnostic tests for lung cancer. The agreement brings together MD Anderson’s “extensive research into predictive biomarkers for lung cancer” with Exact’s “successful development and commercialization of Cologuard,” the press release noted.
One of the planned tests would determine the need for low-dose computed tomography (CT) scans, which combine a series of X-ray screens from different angles and can be used to detect lung cancer. That product would be designed for screening the nearly 11 million Americans who are current or former smokers at high risk of developing lung cancer. Another proposed diagnostic would assess tumors found via CT scans or other imaging tests. Lung nodules—growths on the lungs that may or may not be cancerous—are discovered in 4 million Americans annually, according to the press release.
“Taking on lung cancer offers an opportunity to build on the success of Cologuard,” Kevin Conroy, Exact’s CEO and chairman, said in the release. “A simple blood test to complement CT could significantly improve early-stage lung cancer detection. Our experience working with regulators and insurers, coupled with MD Anderson’s world-class research and development capabilities, are an ideal match to make a meaningful difference in the war on cancer.”
Cologuard won FDA approval and preliminary Medicare coverage on the same day last August—the first time that’s happened. The test—which was developed with help from Mayo Clinic researchers—requires patients to ship a stool sample to Exact’s lab, where a DNA analysis determines the likelihood that the person has colorectal cancer. Regulators green-lit Cologuard based on the strength of a massive 10,000-patient clinical trial, which showed the test was superior in nearly every measure to the fecal immunochemical test (FIT), a common non-invasive colorectal cancer screener.
Cologuard sales have started to ramp up this year, as Exact has expanded its sales team from 80 to 140 people and convinced more private insurers to cover the test. Exact reported $4.3 million in revenue in the first quarter this year, up from $1.5 million in the fourth quarter last year.
But the lung cancer endeavor could prove more challenging because the market is much more competitive than colon cancer diagnostics.
A number of companies are developing (or have already commercialized) blood-based and other non-invasive tests that can detect lung cancer. The popular approaches include tests focusing on cell-free DNA, or cfDNA, which looks at DNA from dying cancer cells that spills into the bloodstream; and circulating tumor cells, or CTCs, which are tumor cells that break off from a tumor into the bloodstream. Guardant Health is among the companies taking the cfDNA approach, while those working on CTC tests include Houston-based ApoCell and San Diego-based Epic Sciences.
Meanwhile, Cambridge, MA-based Exosome Diagnostics is developing a blood-based lung cancer test that examines the RNA in exosomes, tiny bubbles that are released by all living cells and can be found in blood. Veracyte recently launched a lung cancer diagnostic that analyzes genomic changes in epithelial cells that line the lung’s respiratory tract. Seattle’s Integrated Diagnostics also has a blood-based test on the market that determines whether lung nodules are benign.
The bottom line is, Exact and MD Anderson are diving into an increasingly crowded field. And it’s not clear yet exactly what approach their lung cancer diagnostics will take—or how they plan to beat their rivals.
Sam Hanash, a doctor who directs MD Anderson’s cancer detection and treatment institute, said in the press release that the “goal is to choose the best-performing biomarkers for our panel across multiple technologies.” The proposed diagnostics will use a combination of protein and DNA biomarkers, “similar to the approach with Cologuard,” an Exact spokesman said.
“MD Anderson is already researching biomarkers capable of detecting lung cancer in the blood, both before and after symptoms appear,” Conroy said in an e-mail message. “Although not yet fully validated by a screening trial, the results to date are promising.”
Conroy declined to go into more detail about the science behind the proposed tests.
The goal would be to detect lung cancer earlier, when there’s a greater probability of defeating it. Most lung cancer cases are diagnosed after symptoms appear—when the five-year survival rate is in the low single digits, the press release said. But when diagnosed earlier, the five-year survival rate can climb to 80 percent.
Lung cancer is the second-most common cancer (behind skin cancer) and is the leading cause of cancer-related deaths, according to the American Cancer Society. This year, about 221,200 people will be diagnosed with lung cancer and 158,040 people will die from the disease, the group estimates.
“Lung cancer is, and will continue to be, America’s leading cancer killer unless we identify new approaches to diagnose it early, at its most treatable stages,” Hanash said in the press release.
Currently, a CT scan is the primary method of screening for lung cancer, but it “carries significant limitations,” Conroy said. CT scans are good at detecting tumors, but they also turn up a lot of false positives. Exact says 96 percent of all nodules found by CT scans are benign, which leads to “unnecessary and often harmful invasive procedures, radiation exposure, and high costs.”
“In contrast, a simple blood draw that could be done at a physician’s office, perhaps as part of a patient’s annual blood test, could improve early lung cancer detection and screening accessibility,” Conroy said, referring to the diagnostics that would analyze the blood sample.
The idea would be to offer a blood-based test that complements CT scanning by being more accurate—meaning fewer false positives—and helping to limit CT procedures to those with the highest risk of lung cancer, according to a report by Exact and MD Anderson. The proposed blood-based tests could also lower healthcare costs, with a price in the hundreds of dollars, compared with CT scans that cost $3,100 on average, an Exact spokesman said.
The first product developed through the partnership could enter clinical trials some time next year, the spokesman said.