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GHS Expands Clinical Sequencing with Rare Tumor Center, Partnership with Foundation Medicine

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South Carolina's Greenville Health System has expanded its clinical sequencing efforts with a new Rare Tumor Center that, as part of a strategic alliance with Foundation Medicine, will test the center's first patients with rare cancers using the company's FoundationOne targeted cancer sequencing test as part of an 18-month study.

Beyond that study, which will recruit up to 60 patients, the new center may also take advantage of other commercial sequencing services or technologies, Jeffery Edenfield, medical director for GHS'' Institute for Translational Oncology Research and the architect of the new center, told Clinical Sequencing News this week.

This could include sequencing performed by Selah Genomics — which already partners with GHS for clinical cancer sequencing as part of the Selah Clinical Genomics Center at GHS's ITOR — or other emerging technologies and sequencing strategies, Edenfield said.

The Selah center, announced last year, has been offering a test called PrecisionPath using Ion Torrent's AmpliSeq panel on the PGM.

According to Edenfield, the Selah partnership is still going strong. Though the team has been thinking about trying to expand the targeted sequencing panel offered through that program, they have not yet done that, he said.

Currently, the Clinical Genomics Center has been analyzing between 20 and 40 patients a month, he added, with the hope that they can push that up to 80 patients a month in the future.

Bringing in Foundation Medicine as a player in the new Rare Tumor Center shouldn't eclipse the Selah project, Edenfield said.

"We didn't trade one for the other," he said. "We are still screening everyone who comes through with cancer with that basic panel, and that all goes into our biorepository [so] as we populate more rare tumors in [that database] it will develop more expertise for [Selah] in that regard."

However, said Edenfield, Selah doesn't currently offer a panel competitive with Foundation's assay.

"[Foundation Medicine is] the big gorilla here at this point," he added. "They have a very refined product and a very large database, and in our discussions with them, we talked about how if we find a patient with a very rare cancer we can then turnaround and query their database [to see] if there are others in there that might look mostly the same."

The group hopes that its access to this relative wealth of data will allow it to link up rare cancer cases with each other, identifying subsets that might share molecular features indicating an effective treatment strategy.

"If there are three patients — as small as that number is — and they are all molecularly similar, you can make an argument that that's what's driving the cancer and we should treat people in such a way," Edenfield explained.

"If you look in the last 30 or 40 years, all the advances have been through clinical trials, and there are no patients more disserviced by this mechanism than those with rare cancers because there is just no way to do the trial," he added.

With sequencing costs dropping and clinical sequencing becoming an increasingly explored tool, Edenfield said the GHS ITOR group thought it could be a way to, if not create the same resource for rare cancers that clinical trials have provided for more common diseases, then at least standardize the way these patients are evaluated.

"The idea is that everyone with [a rare tumor] gets the best sequencing du jour," he said.

Currently, the GHS team has decided that Foundation Medicine's offering is the most appropriate for this program.

As part of the protocol GHS has arranged with the company, Edenfield said up to 60 patients in the first year of the new center's activites will be evaluated using Foundation's test. "If there are others beyond the 60 – we might want to open it to everything that is out there [but] when you are sitting there with a patient and their family, you want to be able to say, 'Here is what I think is the optimal assessment right now,'" he added.

"Hopefully we then send them back home with an agreement to let us track them and interact with their doctors to see what their response is and how long they were stable – to help build on this [knowledge] for the next group of patients," Edenfield said. "And looking out, we are hoping eventually that this can be employed everywhere — [that] if you meet the criteria for a rare cancer, we can say, 'this is what you should be having and what your insurance company should be expecting.'"

"We believe we need to demonstrate that molecular evaluations should be in the guidelines for rare cancer the [same] way there are guidelines for [other types of cancer care]," he said.

Edenfield said he began sequencing rare tumors informally over the last few months, seeing about nine patients before GHS announced the new center last week. Since then, he said the center has had two referrals.

Overall, he said the team is prepared to sequence up to five or six patients a month.

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