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Foundation Medicine's GeneKit Offers Interpretation, Reporting Tools for Pathologists

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NEW YORK (GenomeWeb) – Seeking to engage with pathologists offering targeted oncology tests, Foundation Medicine has launched GeneKit, a new portal that is designed to help this group of potential clients interpret and report the results of next generation sequencing-based hot spot assays.

Foundation Medicine President and COO Steven Kafka explained that the new product targets pathology laboratories running hot spot assays that do not have access to ready-made interpretation tools to make sense of the data they generate. Once they have run patients' tumor biopsies through their tests, pathologists face the often time-consuming and sometimes expensive task of analyzing their findings and communicating them to treating oncologists. They either outsource their interpretation needs or try to perform the interpretation manually, a task that can take about four hours per report on average, Kafka told GenomeWeb.

GeneKit is intended to serve as a simpler, more cost-effective alternative, according to Kafka. It lets pathologists take advantage of information contained in FoundationCore, Foundation Medicine's knowledgebase that contains more than 50,000 genomic profiles from patients with lung, breast, colon, and other kinds of cancer who were analyzed using the FoundationOne test.

Underlying algorithms compare mutations from patient samples to curated genomic variants, published research results, and targeted therapy and clinical trial information contained in FoundationCore, and generate genetic reports that can be combined with other kinds of clinical data information — radiology results for example — in a final report presented to treating oncologists. When their own hot spot tests return no results or insufficient results, pathologists can use GeneKit to order Foundation Medicine's tests. Essentially, it is designed to "meet [pathologists] where they are in terms of enabling their in-house NGS-based testing and providing them with this rich content, and then where appropriate, reflexing for further testing using our products," he said.

Initially, Foundation Medicine is making GeneKit available to a group of select unnamed pathology labs, with plans to make the portal more broadly available over the next several weeks to months. The company will use the initial period to further hone and improve the system based on customer feedback, as well as to determine the best revenue model — a license-based model or a pay-per-report model — for access, Kafka said. The firm is not disclosing specifics about potential price points, but during a presentation at the Morgan Stanley Global Healthcare conference held this week, Foundation Medicine CEO Michael Pellini said that the company would offer access to content through GeneKit for "a very small fee."

GeneKit's launch is part of a broader informatics strategy that includes building tools that leverage the content available in FoundationCore to help physicians make better point-of-care decisions and to support the efforts of the biopharmaceutical industry to develop new treatments, repurpose existing drugs, and identify candidates for clinical trials. In addition to its large size, FoundationCore is unique, according to Kafka, in that it offers access to data from "real world cancer cases" rather than from primary tumors used by projects like the Cancer Genome Atlas. Foundation Medicine's samples were collected from patients with metastatic and late stage cancers, which are of particular value to pharma companies, for example for clinical trial purposes, as well as to oncologists searching for more effective treatment options for their patients, he said.

Other informatics tools in the company's portfolio that use FoundationCore's content include PatientMatch, which is designed to help physicians locate patients with matching tumor genomic profiles to their own patients within the Foundation Medicine network, and then connect with treating physicians and exchange information about therapy decisions and outcomes. PatientMatch, which Foundation Medicine launched at the American Society of Clinical Oncology meeting this year, is part of the company's Interactive Cancer Explorer (ICE) software system, which doctors use for tracking samples and reports, as well as for ordering tests.

During a presentation at Foundation Medicine's analyst and investor day held this week, Kafka said that there are currently more than 8,000 cases available for matching within PatientMatch.

Foundation Medicine is also developing a tool that will enable doctors and patients greater access to clinical trials run by pharmaceutical companies. Kafka said during his presentation that Foundation Medicine is also working with pharma and biotech companies to incorporate detailed clinical trial information into FoundationCore, including data on molecular targets of trials, clinical trial status and location, as well as which trials are open.

The company is developing a tool called SmartTrial that will let physicians query patient cases against the data in FoundationCore and get information about open clinical trials, prioritized based on what is most pertinent to the patient in question, Kafka said.