NEW YORK (GenomeWeb) – Seeking to provide physicians with streamlined access to oncology clinical trials that are tailored to their patients' molecular profiles, GenoSpace has begun beta testing a new mobile application called Trial Match.
The company is currently testing the app with at least one unnamed customer and hopes that it will be approved for inclusion in the Apple iOS store in the next few weeks, Mick Correll, company CEO and co-founder, told GenomeWeb. Depending on demand, the app could also potentially be made available to Android users.
Trial Match leverages the existing capabilities and infrastructure of the broader GenoSpace suite to match cancer patients primarily to relevant trials. It connects to existing hospital systems including electronic medical records and laboratory software systems and extracts clinical information collected at the point of care and molecular information from tests and uses it to match patients to trials information gleaned from sources such as Clinical Trials.gov.
Physicians can review trials that the system matches their patients to, contact principal investigators, and inform their patients about available trials. The system automatically updates patient matches as new information is added to the underlying data sources and sends notifications to physicians about these changes. Separately, GenoSpace also offers a desktop portal that allows system managers to view all patients and trials as well as track the matches and referrals that are being made via the app.
"One thing that has become clear in our time working in this space is that clinical trial optimization is one of the key strategic priorities for a number of different groups in the ecosystem." Correll said. Life sciences researchers need tools that let them efficiently recruit patients for their studies while healthcare providers are looking to provide better care and keep patients within their networks.
Efforts such as the Oncology Research Information Exchange Network's Avatar Research Program — an industry-academia partnership led by health informatics firm M2Gen — aim to fill that need by creating a repository of de-identified genomic and clinical information from patients treated at participating cancer centers. Last year, the Guardian Research Network said that it was forming a consortium of large community-based health systems that would use a panel and clinical decision support system offered by Molecular Health to identify subpopulations of patients for clinical trials from larger cohorts of hundreds of thousands of patients. In 2014, Foundation Medicine partnered with EmergingMed to help physicians identify appropriate trials clinical trials for patients based on the results of Foundation One tests.
Meanwhile, Cure Forward is offering a clinical trial matching platform that lets patients post anonymized profiles that include information about their tumors, treatments, and location preferences for 30 days. Clinical trial recruiters can search the platform for patients who meet the criteria for their trials and then invite them to participate. The company gets paid when patients access clinical trial invitations from recruiters.
GenoSpace for its part has worked with clients in commercial labs seeking to match patients to trials based on test results as well as with patients participating in the community portals that the company has created to allow patients to share information about their medical histories and conditions. An example of one such community, launched in 2013 in collaboration with the Multiple Myeloma Research Foundation, provides a portal through which patients living with the disease can share information, connect with each other, and be informed about clinical trials that they may be eligible for based on characteristics such as specific mutations.
The new app is intended to make all of GenoSpace's existing functionality in the clinical trial matching space accessible at the point of care and via a mechanism that physicians are more likely to use, Correll told GenomeWeb. Existing EMR systems, which doctors are mandated to use, generally aren't set up to handle molecular data and physicians are less likely to want to log into a second separate portal to access information they need for their patients. "What we've found is that ... a mobile phone is surprisingly an effective way to actually reach doctors at the point of care," he said. "We can take advantage of things like touch-ID so they [only] need to enter a password the first time they come in." Moreover, according to a 2015 report, 84 percent of physicians use smartphones for work and over 51 percent use both a smartphone and tablet for work.
Powering the app are GenoSpace's Population Analytics and Clarify solutions. Population Analytics offers tools for combining and visualizing clinical and molecular information from patient cohorts and for stratifying and visualizing data from patients based on specific criteria; as well as methods of comparing patients based on different variables. Population Analytics is used for things like a new precision medicine initiative that Canadian startup Sequence Bioinformatics is working on with the Newfoundland and Labrador government that aims to gather genomic and phenotypic information from 100,000 consenting participants in the province. For its part, GenoSpace Clarify provides a workflow that helps users curate their molecular, clinical, and other information.
Essentially, the app is fed by streams of genomic and clinical data gleaned from customers' EMRs and other systems as well as from Clinical.Trials.gov database, Correll explained. "There's a lot that can be done with summary-level trial information ... but we've found that the full trial protocols are much more detailed in terms of the specific inclusion/exclusion criteria" and enable more accurate matching, he said "So we extended [the] data curation platform that we had developed for our molecular clinical decision support and adapted this to be able to do a really deep curation across about 12 different domains" including tumor staging and performance, among other characteristics.
Within the system, the curated and harmonized clinical and genomic datasets gleaned from the customer site are mapped to the same terminologies used for clinical trials. This way, GenoSpace's algorithms can map information contained in the customer dataset to the clinical trial protocols and score matches. The system then sends alerts to physicians' phones through the app letting them know about the potential match. Furthermore, patient matches are updated as necessary as new information is added to the EMR or as new trials come online.
"Today we think this is probably most relevant for oncology, but we certainly see potential for it to grow beyond that" as the biomedical community's understanding of molecular factors associated with other diseases matures and the use of molecular profiling grows, Correll said. "We are looking at a lot of diseases that we think are going to be coming online" including cardiology, neuropsychiatry, or rare and inherited diseases, he said. "Oncology is the initial focus largely driven by the molecular complexity that exists there today but we fully expect that the app can be rolled out across other disease indications."
GenoSpace isn't discussing specific details about pricing for access to its clinical trial option. However, Correll noted the app is not a standalone solution as it does depend on existing GenoSpace products to run. "This isn't a general iTunes store download," he said. "GenoSpace population analytics is what's driving the creation of that harmonized clinical and genomic data model [and then] there's the curation end of things, which is our Clarify offering, and the matching engine and app that go along with that."
The company is open to launching the app on the Android operating system but it will wait to assess whether this is something that doctors want since, according to its research, more than 70 percent of doctors use iPhones. "It is something that we have planned [but] will be driven in part by commercial demand," he said.
Cambridge, Massachusetts-based GenoSpace opened its doors in 2011 to offer solutions for linking clinical and genomic data. When it launched initially, GenoSpace focused largely on addressing the needs of clinical laboratories looking to offer molecular testing, Corell said. And while that continues to form an important part of the company's business, it has more recently gained traction in the hospital and health network market and anticipates that this will be a significant growth area, he told GenomeWeb. Companies like Syapse are also targeting the health systems space and offering platforms that integrate multiple streams of patient data, enable clinical trial eligibility assessment and enrollment, provide tumor board guidance, facilitate patient engagement, and address other needs particularly in the context of oncology.
"We think of providers and clinical labs as segments of the clinical market because we are deploying similar underlying capabilities, but with different front-end applications. As an example, we have released the clinical trial matching app for providers this year, but clinical laboratories have been matching patients to clinical trials for years through our FullView molecular profiling application," he said. "Similarly, we have both provider and lab customers relying on our population analytics offering to analyze cohorts across population-scale datasets. [So] while they may have different use cases, the underlying need to integrate genomic and other clinical data for population-scale analysis is quite similar."
Correll believes that there are a number of potential players that compete with different aspects of the company's portfolio, however, "we have yet to run into a competitor that offers our full suite of offerings," he told GenomeWeb.
The company will be relying at least in part on its relationships with clinical labs and early clients in the health systems space to help push its products into the provider space, according to Correll. One such client is the Inova Health System, a not-for-profit healthcare system in Washington, DC, which is using the Population Analytics solution to analyze and explore clinical and genomic data from an ongoing sequencing effort initiative. These referrals coupled with "our experience [in] handling protected health information ... is crucial for growing market share in the provider market," he said.