NEW YORK (GenomeWeb) – Intermountain Healthcare is offering a targeted next-generation sequencing-based panel internally to all patients with refractory cancer and will soon begin offering the service externally.
The Utah-based healthcare system has been offering the 100-gene panel internally for about one year, initially to refractory patients with gastrointestinal or lung cancer. It has now broadened its eligible patient base to all cancer patients with metastatic cancer, including those with solid tumors and blood-based cancer.
Lincoln Nadauld, director of cancer genomics at Intermountain, told Clinical Sequencing News that the center has analyzed around 200 patients and found actionable results in about 70 percent of them. In addition, the majority of referring oncologists end up making treatment decisions based on the genomic findings, he said.
"Genomics can identify alterations that are actionable and sometimes provide treatment options that we wouldn't have known about otherwise," he said. "It's playing an incredibly important role in the management of cancer patients."
He said the cancer genomics group at Intermountain decided to develop its own customized panel because it wanted a limited gene set, but also wanted something more comprehensive than a hotspot panel.
Intermountain currently offers a panel of approximately 100 genes that is sequenced on the Illumina MiSeq, but as the center scales up, it will begin running the panels on the HiSeq system, Nadauld said.
"We're specifically avoiding exome and whole-genome sequencing," he said. "While powerful, they provide too much information — information that we don't always know how to interpret."
The goal for turnaround time is two weeks, although currently it is closer to three to four weeks, Nadauld said. The longest lag time is in obtaining samples, but that is getting faster as the center becomes more familiar with the laboratories that take the patient sample, he said.
Nadauld did not disclose the cost of the panel, but said it is in line with other commercially available cancer panels. Additionally, he said that the center has had good success in obtaining reimbursement. While not quite as successful as Washington University's Genomics and Pathology Services laboratory, whose reimbursement rate is around 90 percent for its 40-gene cancer panel, Nadauld said that Intermountain's rate is only slightly lower.
Intermountain Healthcare includes in its report to oncologists actionable variants, which it defines as alterations that have been functionally validated in the literature for which there is therapeutic intervention, Nadauld said.
One main challenge in offering the test has been analysis, interpretation, and figuring out what to do with variants of unknown significance, Nadauld said.
"There is a whole classification of variants we find that haven't been functionally validated. We can make predictions based on tools, but if it is not validated, we don't guess," he said.
Intermountain does include the list of variants of unknown significance in a separate part of the report so that the clinicians know that they are there, he said.
Another challenge has been in obtaining the appropriate drugs, Nadauld said, particularly if a drug is approved but not for the patient's specific cancer. He said that Intermountain now has infrastructure in place to help oncologists and patients navigate the process of obtaining drugs and getting insurance to pay for them.
One facet that makes Intermountain unique is that it is an integrated healthcare system comprised of 22 hospitals and 182 clinics that includes all of Utah, parts of Idaho, Wyoming, Colorado, Nevada, and Arizona. There is also both a payor and provider arm. The payor side is an independent entity, and patients that come to Intermountain do not have to also have Intermountain insurance, but the set-up makes the dialogue between provider and payor smoother, Nadauld said.
"If you find something in the panel and want a certain medication, it's easier to have a conversation with the payor side for why you want to do that," he said.
Thus far, he said that the patients who have received treatment based on the targeted panel have done surprisingly well. Speaking at the Clinical Genome Conference in San Francisco last month, Nadauld discussed several cases.
One was a 40-year-old male with metastatic colon cancer who was wheelchair bound. The targeted panel identified a HER2 amplification, for which there are targeted therapies approved in breast cancer.
The patient was given ado-trastuzumab emtansine (T-DM1), marketed by Genentech as Kadcyla, which is approved for treating HER2 positive metastatic breast cancer. After three months, his tumor began shrinking. Eventually, he gained enough strength that the wheelchair was no longer necessary, and one year later he is off pain medication and doing well, Nadauld said.
Nadauld said that Intermountain does not have plans to expand its panel beyond the 100 genes it is currently analyzing.
"The desire to use large panels stems from wanting to know more and more information," he said. "The problem is that much of that information is not clinically relevant yet because there are not therapeutic interventions for those genes and payors don't want to pay for information that is not clinically relevant."
While sequencing additional genes makes sense for research purposes, "for clinical purposes, this type of testing needs to be done in a careful way," he said.