In Oct. 2013, it launched the myPlan Lung Cancer test, which it says will help clinicians determine a newly diagnosed patient’s risk of dying from lung cancer within 5 years, and in turn help decide whether an early-stage patient should receive surgery alone or surgery plus adjuvant chemotherapy or radiation therapy.
Foundation Medicine, based in Cambridge, Mass., is working with drug makers to develop companion diagnostics for targeted chemotherapies but is also offering direct to oncologists genomic panels that provide analysis of up to 200 genes. One of the tests is for solid tumors and the other is for hematologic malignancies, sarcomas, and pediatric cancers. The company said in its most recent quarterly report that testing revenues had grown by a third from the year ago quarter.
The FDA is also approving new targeted therapies that would probably be made more useful through the use of genomic testing to winnow down the number of potential patients who could benefit. For instance, in May, the agency approved certinib (Zykadia), a drug that blocks the anaplastic lymphoma kinase (ALK) protein. There is an FDA-approved diagnostic – the Vysis ALK Break Apart FISH Probe Kit – designed to detect ALK gene mutations, but it’s indicated for use only to identify patients eligible for treatment with another therapy, crizotinib (Xalkori).
There’s nothing to stop off-label use, or use of so-called "home brew" tests that are developed in-house at hospitals or clinical labs but not FDA-approved.
The FDA may soon step up its regulation of those diagnostics, said ACS CAN’s Dr. Fleury. "They’ve been very public that they fully intend to bring high-risk lab tests into their purview," he said, adding that many in the field believe that the regulations have already been written. It appears that the only thing delaying those regulations from being issued is White House clearance, Dr. Fleury said.
Meanwhile, many institutions are moving on to next generation sequencing, which involves taking a look at hundreds of genes, not just a single variant. Even with a limited amount of tumor tissue, it maximizes the information that can be gleaned from a biopsy sample, said Dr. Schilsky. It may be less expensive and more efficient than conducting multiple different single mutation diagnostics, he said.
However, right now, "it gives you way more information than you could possibly use at any point in time," said Dr. Schilsky. And, many clinicians have difficulty interpreting such a huge amount of complex information.
Most payers are not approving reimbursement for these multiple gene panels, he said. Even so, "many cancer centers are doing this because they think it provides an important platform for their research, and it attracts patients to their institutions," said Dr. Schilsky.
Dr. Seiwert helped develop a multigene assay, which the University of Chicago recently began offering to its oncology patients. In general, it is not being covered by insurers, he said. But, while the cost of molecular diagnostics – which can run from $1,500-$8,000 per patient – is high, it is not that large when compared with the cost of many chemotherapies, he said. If the testing "leads to treatment that has a higher chance of working, then it’s a very small cost, compared with blindly using a drug," Dr. Seiwert said.
His cancer center is covering the cost of testing when it is not reimbursed. Dr. Schilsky said that, from what he has heard, that is not uncommon. "My understanding from many lab directors is that they are basically eating the costs," he said.
Partly because of economics, genomic testing has not disseminated out of the academic centers. Dr. Seiwert said that he thought that testing for specific mutations like EGFR in lung cancer or HER2 in breast cancer was becoming a standard of practice, but that it was a "moving target" in the community. And, when it comes to larger, multi-gene assays, "my sense is that this is largely confined to academic centers," he said.
Single mutation genomic testing, especially for lung cancer "should be the standard of care, but the evidence is that it has not permeated out to the smaller practices," said Dr. Fleury, of ACS CAN.
"When you come in, you should get the diagnosis and be tested for a mutation right away," said Dr. Fleury, who added that this is not happening on a widespread basis.
Oncologists can often be in an awkward position when a test they want to offer is not covered by the patient’s insurance. If the patient can’t afford the cost, they might feel like they’re not getting something that others can, said Dr. Seiwert. "It’s a messy situation," he said.