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likely comes next. But in between? Nearly two thirds of people with nodules fall into that indeterminate category, according to this Cancer Prevention Research paper; the authors call such growths an “epidemic” whose incorrect diagnosis is costing the U.S. $28 billion a year.
Two companies are competing to solve the problem: Integrated Diagnostics, or Indi, a venture-backed firm in Seattle, and South San Francisco, CA-based Veracyte (NASDAQ: VCYT). The companies’ tests differ in at least one major way. Indi’s test, Xpresys Lung, only requires a blood sample. Veracyte’s Percepta, on the other hand, requires a procedure called a bronchoscopy, in which a tube is threaded down into the lung.
If Indi’s test rules out cancer, there’s likely no need for the tube or any other procedure for that matter (Indi stresses that the course of treatment is ultimately up to the patient’s pulmonologist). If Veracyte’s test rules out cancer, the patient is spared further procedures, but there’s still the initial bronchoscopy. The procedure is already routinely done when an indeterminate nodule is found on a scan as a way to allow a sample of the growth to be snipped off for a biopsy analysis. Percepta testing can be done as an add-on to that procedure by “brushing” a few cells from the patient’s airway for collection. In heavy smokers—the only people Percepta is used for—a 23-gene profile of those cells has a strong correlation to the status of the nodule in question, according to Veracyte. If the regular biopsy can’t determine whether the nodule is malignant, or if the bronchoscope can’t reach the nodule, the collected airway cells are analyzed with Percepta.
Gil Welch of Dartmouth warns that there is danger of lung puncture with a bronchoscopy, and that the complexity of the lung makes reaching many nodules difficult. The possibility of avoiding a bronchoscopy altogether with a blood test would be “a trump card,” he says.
Indi says it has isolated 11 proteins in the blood that serve as the telltale markers of the absence of cancer. Can the company prove to payers that looking at those markers is enough to put some patients on the “benign” track, sparing them discomfort, health risks, and saving everyone money?
Xpresys Lung was launched in late 2013. About a year later, Indi said United HealthCare and six other insurance groups would reimburse for it. They’ve added a couple more insurers since then, representing a total of 225 million covered patients. The list price is $4,275 per test. How much those payers are actually paying is undisclosed; Indi, having raised $77 million in venture capital, remains privately held. CEO Al Luderer says he’s aiming for Xpresys Lung to be a $100 million business in “two or three years.”
The Seattle startup now wants to convince Medicare to offer coverage, too. Its main argument will be a study of 475 people with nodules in the 8 to 30 millimeter range. Indi spent $10 million to run it, says Luderer, and the company will also start gathering data on people who go into watchful waiting based on their Xpresys Lung results, but can’t say at this point when data will be published.
As for the others for whom cancer isn’t ruled out by Xpresys Lung—some 40 to 50 percent of people who take the test—Indi is developing a companion test to determine which ones are “most likely to have cancer,” says Luderer. It should be ready later this year, he says.
Veracyte is farther behind. Its test, Percepta, launched this year. Insurers need to sign on for revenues to start flowing; CEO Bonnie Anderson expects that to take a couple years.
A New England Journal of Medicine paper authored by the test’s inventor and published in May should help get insurers on board, says Anderson. The paper suggested that Percepta would keep 42 percent of patients whose bronchoscopy was indeterminate from undergoing further tests. “It’s a journey, for sure,” she says.
The National Cancer Institute’s director of cancer prevention Barry Kramer said in an NCI blog post, however, that one limitation was that the study only included patients strongly suspected of cancer, not a more general population of smokers.
Veracyte would do well to repeat the path taken with its rule-out thyroid test, Afirma. Four years after launch, the company says it has tested 35,000 people who have undergone a minor biopsy, called a fine needle aspiration, and steered 15,000 of them … Next Page »