Anew program spearheaded by a charitable foundation aims to use molecular testing to fundamentally alter how care is provided to lung cancer patients. The 360 Community Hospital program could be seen as a potential boon for labs that perform the handful of molecular tests associated with lung cancer treatments. “It will have an ultimate end effect on the volume of tests these labs perform,” said Danielle Hicks, director of patient services and programs for the Bonnie J. Addario Lung Cancer Foundation, the San Carlos, Calif.-based philanthropy behind the initiative. Lab executives are a little less sanguine about the business promise of the 360 program. “On the face of it, this would increase volumes,” said Stephanie Astrow, vice president of research and development for Response Genetics, a Los Angeles laboratory that assists a Bonnie Addario affiliate on lung cancer research. But Astrow could not provide any guidance on what that number might be. Instead, lab executives see the initiative as more of a bootstrap to pull closer to the value-over-volume proposition they believe is required for the sector to thrive in the long term. Meanwhile, some pathologists are concerned it could dilute the quality of cancer care and drive up costs. Whatever the doubts, the 360 program is in the midst of a national rollout after a successful pilot program at El Camino Hospital in Mountain View, Calif. Addario officials envision smaller nonteaching hospitals using molecular testing as a matter of course in a couple of years. Currently, many use it sporadically, if at all. Addario officials noted that the 360 program is intended to address the biggest shortfall in lung cancer care at community hospitals—that many patients often wait weeks before receiving accurate diagnoses about their conditions, leading to delays in care and sometimes inappropriate treatment. Patients with the KRAS biomarker, for example, are poor candidates for chemotherapy—something that would not be known without molecular testing. Such issues are apparently commonplace despite the fact that the large majority of lung cancer patients are diagnosed at stage 3 and higher, making swift and precise treatment crucial. “There is no one person or party driving the care decisions. It becomes a serial process,” said Steve Young, president of the Addario Lung Cancer Medical Institute, the foundation’s research affiliate. “There’s a fractionation of medical care—you might see an oncologist . . . then see a radiologist, and a pathologist has to do an analysis—there really is no pathway.” Young added that some doctors may be reluctant to perform a biopsy because of the risk of a lung collapse, and others may not perform molecular testing at all. “There’s a lot of pessimism regarding lung cancer,” he said, noting that five-year survival rates barely top 15 percent. Amy Cunniffe, a senior vice president with Caris Life Sciences, a Texas-based lab that works closely with Addario on its initiatives, echoed Young’s concern. “You want to start with the most effective therapy possible, as soon as possible, and get the most effective shot on goal to beat the cancer,” she said. Molecular testing itself remains a hit-or-miss proposition for lung cancer patients. According to Young, only about 15 percent to 20 percent of patients test positive for biomarkers that suggest drugs such as Tarciva and Crizotinib would be effective in their treatments. But it’s a start, he added. “At least you are looking where you can see. Molecular testing at least will steer you to a beam of light, at least you have a chance for the subset of patients with biomarkers,” Young said. The El Camino Data Every single non-small-cell lung cancer patient at El Camino received molecular testing in the pilot—about 100 patients in all. They underwent a panel of 10 different assays. And despite operating a brand new, technically advanced facility in one of the wealthiest communities in California, El Camino’s lung cancer patients had received molecular testing only 20 percent of the time prior to the pilot. The preliminary results are telling: Diagnosis-to-treatment time was slashed to 10 days from 45 days—a reduction of 77 percent. And nearly two-thirds of the patients underwent a tumor board review—something that rarely happens at a community hospital. As a result, the 360 Community Hospital program is being rolled out to three other community hospitals in the Southeast and East: Lehigh Clinic in Boston, the Northside Hospital system in Atlanta, and the Lynn Cancer Institute in Boca Raton, Fla. Under the program, the hospitals can pick their own outsourcing labs for testing, but the entire 10-test panel has to be performed. Northside, which is also participating in a lung cancer tissue collection program overseen by the Addario Lung Cancer Medical Institute, has been performing two molecular tests since 2008 for its lung cancer patients: EGFR and ALK. Both are outsourced to local labs. Jewel Chang, M.D., a Northside pathologist, noted that the patients are tested for ROS1 if they are negative for the first two tests. It’s the kind of stepped assays that lead to care delays—something that is resolved by undergoing all the panels at once, according to Addario officials. But despite the push for broader molecular testing, some pathologists are concerned that community hospitals are involved in treatment of lung cancer patients at all. “I have a bias in this area—I think all patients should get treated at cancer [specialty] hospitals,” said Bruce A. Friedman, M.D., an emeritus professor of pathology at the University of Michigan and president of the Pathologist Education Consortium. Hicks noted that 225,000 Americans are diagnosed with lung cancer every year, meaning there simply is not enough capacity at specialty hospitals to treat even a large fraction of them. Robert Boorstein, M.D., a pathologist and director at the ClasGroup Co. near New York City, is concerned that such a large panel of tests could lead to unnecessary utilization. “Remember, this is just for [non-small cell], which is 30 percent of lung cancer. There is potential for creep into squamous,” he said. “From a medical insurer perspective, I would not do testing without the physician saying the patient is a candidate for chemotherapy.” Cost is a concern for the 360 initiative—the panel of tests runs about $2,700 to $3,500. And while Hicks noted that most insurers cover EGFR and KRAS tests, others may balk at paying for them all. Response Genetics has agreed to pick up the cost of testing for any patient involved in the 360 initiative if they don’t have insurance. But the labs also seem to agree that the best thing they can do is come up with a BRCA equivalent for lung cancer. “We need to develop a reliable risk-based test,” Cunniffe said. Takeaway: Speeding lung cancer care may boost molecular testing volumes, but without a more definitive diagnostic test, could also increase unnecessary utilization.