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At JPM, Foundation Medicine Discusses Plans for QSR Lab, Next Iteration of Physician Portal

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SAN FRANCISCO (GenomeWeb) – Foundation Medicine said today that it will have a laboratory compliant with the US Food and Drug Administration's quality system regulation up and running this year as it prepares for increased FDA oversight of laboratory-developed tests.

During a presentation at the JP Morgan conference held here, Foundation Medicine CEO Michael Pellini discussed the company's work with regulators and a recently launched second iteration of its physician portal, Interactive Cancer Explorer 2.

In addition, he said that in the first part of 2015, the company will publish a clinical validation study for FoundationOne Heme, its next-generation sequencing-based test for blood cancers. FoundationOne Heme has a sensitivity of 99 percent and a specificity of 95 percent with a turnaround time of 15 to 18 days.

To date, Foundation Medicine has reported approximately 35,000 tests, including both FoundationOne and FoundationOne Heme, of which 82 percent have a clinically relevant finding, Pellini said.  

Foundation's market includes six broad categories: stage four non-small cell lung cancer; rare or uncommon tumors; patients that have exhausted guideline-driven testing and therapies; highly aggressive tumors; cancers of unknown primary origin; and cancers for which there is limited tissue available. Pellini estimated that in the US, the potential market is 1 million patients per year for FoundationOne and 1.1 million including FoundationOne Heme. In the near term, with more positive coverage decisions, he said that would be expanded to 2 million patients per year and eventually to 13 million patients annually in the US as genomic profiling moves to become the standard for all cancer patients.

Last year, Foundation Medicine said that it was building a laboratory to meet FDA quality system regulations as part of its agreement with Clovis Oncology to develop a multi-gene NGS-based companion diagnostic test.

Pellini said today that the laboratory would be up and running this year, and that it would further help differentiate the company, especially as the FDA moves toward increased oversight and regulation. He added that the company is working with FDA "to help them understand and think about how they can develop new guidelines."

As he has previously said, Pellini said that the company welcomes FDA regulation. He added that Foundation plans to bring FoundationOne and FoundationOne Heme through FDA clearance.

"We have a voice at the table [that is] crafting reasonable, appropriate policies to ensure high-quality testing," Chief Medical Officer Vincent Miller said during a Q&A discussion following the presentation.

An increasingly important part of Foundation's business is the data it is collecting in its Foundation Core. "Every test is fed into this and it will be a critical long-term differentiator," Pellini said.

The company is leveraging this core to develop products, such as the Interactive Cancer Explorer, that oncologists can use to analyze data and make more informed treatment decisions.

Late in the fourth quarter, Foundation Medicine launched a second iteration of that physician portal, known as ICE2, Pellini said.

The goal of ICE2 is to make it easier for oncologists to track their patients that have received testing from Foundation and to facilitate communication and HIPAA-compliant sharing of data between oncologists.

For instance, one feature of ICE2 is that when an oncologist opens a specific patient's report, on the bottom right hand corner is a notice indicating how many other practitioners in the Foundation network have patients with a similar genomic profile. The oncologist is then able to automatically generate emails to those other physicians and within 72 hours, if those other physicians have previously agreed to it, the oncologist will receive a response back that includes data on the genomic profile, as well as contact information for that practitioner.

"One of physicians' greatest challenges is knowing how to treat a patient with something they haven't seen before," Pellini said. ICE2 will facilitate sharing between oncologists, which will be especially important for those rare tumor types or difficult-to-treat patients. ICE2 will enable physicians to discuss treatment options for specific alterations.  

Foundation is also looking to expand on its ability to track patient outcomes. Currently, several hundred patients are part of Foundation's registry to track outcomes. In the future, Foundation will expand on this registry and also utilize its existing partnerships with Cancer Outcomes Tracking and Analysis and Flatiron Health to analyze outcome and cost data and to tap into data from electronic medical records.

Pellini said that a third version of ICE will enable oncologists to search Foundation Core to see in real time how patients are being treated and how they are responding.

Right now, ICE is available only to Foundation Medicine clients and access is included in the cost of testing, but Pellini said that the company has been discussing the potential of making ICE more broadly available outside of the firm's client base. However, he added that the company has not decided on if or how it would commercialize such an offering.

Earlier this week, Foundation Medicine announced a collaboration with Roche, which will invest up to $1.2 billion and acquire a majority stake in Foundation. During his presentation today, Pellini reiterated previous comments that the collaboration would not shift Foundation's focus, but simply serve to accelerate it, as the firm looks to move into the realm of liquid biopsies and cancer immunotherapy diagnostics.

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