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Belgium's OncoDNA to Sequence 1,300 Patients Under Breast International Group's Aurora Program


NEW YORK (GenomeWeb) — OncoDNA, a clinical NGS provider affiliated with the Institute of Pathology and Genetics in Gosselies, Belgium, announced last week that it is providing targeted sequencing of metastatic breast cancer patients for a large international effort called AURORA, led by the Breast International Group, a non-profit that facilitates breast cancer research.

As the testing provider for Aurora, which is funded by grants from the Breast Cancer Research Foundation, the Luxembourg Cancer Foundation, Belgium's national lottery, and individual donors, OncoDNA will analyze samples from around 1,300 patients with metastatic breast cancer using the its OncoDEEP Clinical Plus test, which is an adapted version of the 400-gene Ion comprehensive cancer panel on the Ion Proton.

In addition to the comprehensive OncoDEEP Clinical panel, OncoDNA offers clinical customers a more focused targeted sequencing test, OncoDEEP Dx, using the 48-gene Ion AmpliSeq cancer panel. The company also offers Ion Torrent exome sequencing for research purposes.

OncoDNA expanded to its larger Clinical panel, which currently includes 411 cancer-related genes, after launching initially with only the smaller 48-gene panel in 2012.

Under Aurora, which was officially launched this month, OncoDNA will sequence the metastatic breast cancer patients using this expanded panel, Jean-Pol Detiffe, OncoDNA's founder and CEO told Clinical Sequencing News this week.

"I don't know the total budget because it’s a big study," Detiffe said, "but the budget from our side is [around] 7 million US dollars in terms of our agreement … to deliver OncoDEEP Clinical for these first patients."

The overall goal of the Aurora project is to sequence tumor and normal DNA from 1,300 women and men recruited from at least 60 hospitals in 15 European countries. The hope is that the results will help inform the development of new individualized treatment strategies by finding novel genomic associations with treatment response, resistance, and the natural course of metastatic breast cancer.

At the same time, patients sequenced as part of the project whose sequencing results reveal actionable information will also be offered participation in the appropriate clinical trial or treatment with the appropriate molecularly targeted drug "whenever possible," according to the project's description.

According to OncoDNA, the hope is that Aurora can eventually be expanded beyond Europe and to an even larger cohort of patients. Data collected under the effort is also being stored with the intention of integrating the dataset with those of similar projects in the US.

The first patients recruited have been from Belgium, but patients will come from all over Europe, Detiffe explained. "There will be a kit to collect tumor samples, primary and metastatic, and also blood samples, and it will come back to our lab," he said.

In addition, OncoDNA will also use a selection of breast cancer-specific immunohistochemistry assays, including ER, PR, and Ki-67, to add another layer of molecular data. This adjunct IHC testing is something the company is also providing commercially as a "Package Plus" add-on to both its Dx and Clinical panels, Detiffe added.

OncoDNA's testing is performed by its partner, Belgium's Institute of Pathology and Genetics. Currently, Detiffe said, the company is using two Ion Protons and two Ion PGMs.

Turnaround time for the larger Clinical panel is 10 days or less, he said, while for the smaller Dx panel, it can be less than 7 days.

"That's a key factor for us compared to competitors like Foundation Medicine," Detiffe said, as is the company's ability to add IHC, FISH, and other adjuncts like methylation analysis.

Currently, Detiffe said, OncoDNA's Dx panel starts at €990 ($1,371), while the larger Clinical panel costs €1,990. Adding on IHC or other adjunct testing to either service is an extra cost.

Since launching its NGS service commercially last year, Detiffe said the company has sequenced patients from 15 countries. These customers have been referred both through larger cancer centers and private oncologists. Some have also been patients knowledgeable about genomic testing who requested the service of their oncologists.

"We don't count all people coming from studies we have participated in … but coming from patients that have paid for the test since June or July of last year it has been about 400," Detiffe added.

OncoDNA previously said it was developing an integrated web-based report to combine data from histological pathology reports, sequencing data, information about clinical trials for which the patient is eligible, and a list of available drugs that the sequence data has indicated would be effective or ineffective.

This work is still ongoing, Detiffe said this week.

The company also indicated previously that it planned to eventually offer clinical exome sequencing, but Detiffe said that OncoDNA currently feels like whole-exome sequencing is not needed in oncology clinical care.

Although OncoDNA would plan to offer clinical exome sequencing when it becomes merited, "we don’t think there is a need in the market for the moment to have too [much] information with too many genes. We want to concentrate where there is interesting information, so not on increasing the panels necessarily, but definitely in adding complementary information like the IHC [and other testing]," he said.