seeking to find biomarkers in blood that can provide good predictive diagnostic information to doctors. Salt Lake City-based Myriad Genetics (NASDAQ: [[ticker:MYGN]]) recently began selling an RNA-based test of 31 genes that attempts to determine a patient’s risk of dying from early-stage lung adenocarcinoma within five years. The test’s initial list price is $3,400, Myriad has said. [Updated to include Myriad test.]
Many academic groups have worked on this problem, but have found it hard to zero in on just one protein that provides a confident signal of safety, or high risk. The problem is a whole lot more complicated, biologists have learned. The team from the Institute for Systems Biology and Indi sorted through 371 proteins, in millions of different combinations, before settling on a signature set of 13 proteins that are associated lung cancer, lung inflammation, and networks that show when cells are under stress from low-oxygen environments. The test uses a sensitive protein scale called a mass spectrometer from Agilent Technologies, coupled with a proprietary assay and bioinformatics program, to read what’s up with the 13 proteins and spit out an answer on whether the patient has a benign mass, or “nodule” on his or her lung.
All that science goes on behind the scenes, and isn’t really that important to a doctor or patient. But it does represent a potentially important new source of information, Rizzo says.
When a lung screening test shows a suspicious nodule, there are several things a doctor can currently do, Rizzo says. A series of CT scans, over months or years, could be ordered up to keep an eye on whether it grows. A PET scan could be done to get a different type of image. Or an invasive procedure could be done to extract a lung biopsy, which provides critical tissue that can be analyzed in a laboratory to determine whether it’s malignant cancer.
Each approach has its drawbacks. A series of CT scans, even with low-dose radiation, exposes a patient to an accumulating amount of radiation, which isn’t good. The patient, for months, has to go about their daily life wondering whether he or she has cancer. A PET scan isn’t cheap, and it can also give “false negative” results which provide a false peace of mind. Biopsies of the lungs aren’t easy to extract, they involve some sedation, and come with some risk, Rizzo says. Surgery is surgery, and has its own complications, and costs.
The real test for Indi will be to show that even if it charges several thousand dollars for its blood test, it can save the healthcare system money by cutting down on unnecessary CT scans, PET scans, biopsies, and preventive surgeries. If it’s going to do that, it needs to present data that shows its test is not only scientifically accurate and reproducible, but that it delivers some of those benefits for the healthcare system. If, for example, doctors still go on to order excessive CT or PET scans after getting the Indi blood test result, then it wouldn’t really be delivering on its claims of saving the healthcare system money.
Indi, like most diagnostic companies, is going to take on considerable reimbursement risk in the early going. If a doctor wants a test, Indi will provide it, and then try to negotiate for reimbursement from the patient’s insurance company—rather that offload the reimbursement risk onto the physician. This way, Indi can encourage physicians to order its test without shouldering a financial risk on their practice. But it can take months for the company to collect from insurers, and even then it won’t expect to get 100 percent of what it’s asking for. Luderer says most high tech labs like Indi eventually get about 75-80 cents on each dollar they bill.
Ultimately, it will all come down to whether people believe in the test, and it cuts down on other excessive tests in a patient’s diagnostic odyssey. If Indi can prove that, it just might reward its investors and employees and make enough money to see if it can do it again.
