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Roche Introduces Clinical Trial Matching Feature in Navify Tumor Board Solution

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NEW YORK (GenomeWeb) – Roche this week introduced a new application within its Navify tumor board platform that allows researchers to match patients to clinical trials based on certain attributes, such as the molecular features of their tumors.

In October 2017, Roche launched Navify, a cloud-based workflow tool that oncologists, molecular pathologists, clinical trial coordinators, and anyone involved in a tumor board can use to pull in information to make a collaborative decision about a cancer patient's treatment. Navify, Roche's flagship product out of its newly minted digital diagnostics division, is able to integrate clinical data from electronic health records, imaging reports, and lab results.

Traditionally, sharing patient information within tumor boards has been cumbersome, with oncologists putting together the pertinent information manually and sharing it with colleagues via PowerPoint presentations. With Navify, "all of that data is brought into one repository that allows the oncologist to better discuss the patients within tumor boards," Rob Manor, head of sales for diagnostics information solutions within Roche Diagnostics, said during a presentation at the Precision Medicine for Hospital CEOs meeting in Nashville, Tennessee.

Between 20 and 25 customers, from community-based health networks to large academic centers, are currently using Navify. Roche has publicized pilot projects with University of Missouri and Hospital del Mar in Barcelona.

The clinical trial matching feature went live this week for users along with a publications searching app, and are the latest in a series of functionalities that Roche will introduce for its tumor board solution. Roche collaborated on these two apps with MolecularMatch, a company that uses natural language processing algorithms to create a precision medicine knowledgebase that includes information about targeted drugs, clinical significance of genetic variants, and ongoing studies.

When using the clinical trial matching feature, users can look for studies based on patients' age, gender, biomarkers, and other tumor information from 11 international registries, among them ClinicalTrials.gov, the German Clinical Trials Registry, and the European Clinical Trials Registry. Manor highlighted that the app is test-agnostic and can take the variant call file for a patient from an institution's sequencing lab or from an outside lab, analyze it through a decision support algorithm, and match the patient to a trial based on the molecular features of the cancer and other characteristics.

"[The app] does so not just for that patient's known molecular drivers, but also by looking at variants of undetermined significance," he said. "It would match patients down to that level."

It is estimated that around 5 percent of adult cancer patients participate in clinical trials. Roche is launching the clinical trial app hoping it will make it easier for doctors to find the studies their patients are eligible for and increase the number of research participants. Manor noted, however, that even after being matched to a clinical trial some patients can find they still don't qualify for a study, since certain disqualifying criteria may not be detailed in study registries and therefore not captured in the matching algorithm.

Similar tumor board software solutions with clinical trial matching features are also available through Oncolens and Syapse. These software solutions are increasingly necessary in the era of precision oncology as more patients are genomically profiled, and testing identifies rare tumor markers for which there are often no FDA-approved therapies. In such scenarios, doctors are challenged to use the patient's clinical information, the published literature, or n-of-one experiences at different institutions to determine whether it is appropriate to prescribe a non-standard treatment targeting a specific molecular marker or get the patient on a clinical trial.

At the same meeting last week, Howard McLeod, founding medical director of the DeBartolo Family Personalized Medicine Institute at Moffitt Cancer Center, noted that a major reason a lot of cancer patients aren't benefiting from precision oncology is lack of access. "If you have your whole genome done and if you don't have access to proper interpretation or therapeutic options, often clinical trials, you might as well not have had your genome done,” McLeod said during a separate presentation on how Moffitt is operationalizing its precision medicine program, including using a molecular tumor board-like multidisciplinary expert body, dubbed the clinical genomics action committee.

Through decision support tools, Roche is hoping to bring more efficiency and organization to the work of tumor boards as they try to improve precision oncology access to patients. Navify allows members of a tumor board to discuss a patient's case, experience with treatments, and query PubMed for articles relevant to that patient's care. This discussion can take place with the patient deidentified. The platform can also create a record that experts can go back and reference.

"And what this allows the clinicians to do is make sure that the therapy that's chosen and discussed in the tumor board … whether it's a clinical trial or an off label [treatment] recommendation, is the appropriate therapy, and they can reference articles and patients before that have been given those therapies and have responded well," Manor said. The platform allows doctors to track outcomes longitudinally to gauge how their patients fared on the therapies chosen by the tumor board.

Next year, Roche plans to introduce additional apps within Navify that leverage the data within newly acquired companies Foundation Medicine and Flatiron Health. In June, Roche purchased outstanding shares of NGS cancer profiling firm Foundation for $2.4 billion in a merger agreement, and in April it completed the acquisition of health information technology company Flatiron for $1.9 billion.

A collaboration between Foundation and Flatiron resulted in a clinico-genomics database, in which Flatiron linked deidentified electronic health records from 30,000 patients treated at more than 200 US cancer centers with anonymized results from genomic tests performed by Foundation Medicine. According to Manor, Roche plans to introduce patient pooling features within Navify that will allow oncologists to compare their own patients' data against the deidentified data amassed by the two firms.

"You can envision how within the Navify tumor board, and some of the applications that will be part of that in the future, clinicians will be able to query [the genomic and outcomes] data in a deidentified manner … and use it to make the most appropriate treatment decisions for patients," he said.

The outcomes data that Roche has access to through Flatiron could also help improve coverage for non-standard treatments prescribed based on genomic profiling data. "The challenge has always been getting therapies covered based on the molecular profile," Manor said.  

Advanced cancer patients generally have limited treatment options, and as a result, tumor boards often consider non-standard-of-care, off-label therapies, or molecularly-informed clinical trials based on NGS results. Oncologists have not been shy about the fact that it can be difficult to get insurers to pay in these scenarios. However, Manor expects the reimbursement environment for precision oncology strategies will improve over time, particularly following the Centers for Medicare & Medicaid Services' national coverage determination earlier this year for FoundationOne CDx and other FDA-approved or -cleared NGS cancer panels with companion diagnostic indications.

Manor also assured that Roche does not claim any ownership of the patient data within Navify,  which is a common concern among users because the platform is owned by a biotech. "The question we get most often is what are you going to do with my data," Manor noted. Once the data is in Navify, Roche doesn't have permission to go into the system to access it.  

"We have no desire to repurpose or resell any of the data being housed within the Navify tumor board solution," he said. "That is that institution's data."

Since only a minority of cancer patients end up participating in clinical trials due to stringent enrollment criteria, that data within an institution could also provide key real-world insights into subsets of patients at an institution that may be benefitting or not benefitting from a treatment. The patient pooling capabilities that Roche plans to introduce within Navify could capture such insights and spur institutions to go to biotech and pharma companies and make the case for bringing certain clinical trials to their institutions, Manor said.

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