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Massive Bio Seeks Pilot Participants to Test-Drive Oncology Clinical Decision Support System

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NEW YORK (GenomeWeb) – New York-based healthcare informatics startup Massive Bio is seeking early-access customers willing to participate in two pilot projects to test an onsite version of its oncology clinical decision support system (CDSS), scheduled for launch this summer, as well as an on-demand service option of the same platform.

The New York-based firm is targeting community-based oncology practices, academic hospitals, the pharmaceutical industry, and payers in an effort to help oncologists in these contexts bring advances in molecular diagnostics and large quantities of cancer biomarker data to bear on their clinical practices.

Although there are multiple tumor profiling services and laboratory-developed tests that aim to personalize cancer treatment and care, there are currently no good tools for integrating the results of these tests with other pieces of information that have been collected on the patient, according to Selin Kurnaz, the company's co-founder and CEO.

Oncologists working in major academic centers may have access to resources that enable them to combine and use this information in tandem but not all patients are treated at such centers, she said. Instead, many patients visit community oncologists who work in smaller practices and may not necessarily have the time to keep pace with the proliferation of molecular diagnostic tests and treatments. And even if they do order the tests, bringing the information to bear on their patients' care remains a challenge.

Massive Bio's clinical decision support system integrates information from patients' electronic medical records — including clinical history and workup, results from laboratory tests including sequencing, treatment strategies, and patients' responses to those treatments — with evidence-based guidelines, information from clinical trial and drug databases, similar case studies, and molecular information.

The company has set up a network of over 20  oncologists and molecular diagnostics experts who affiliated with cancer centers, research labs and molecular diagnostics companies, who work with treating oncologists to review the information and recommend care and treatment strategies categorized by reimbursability and ease of action. That list of suggestions could include therapy suggestions, eligible clinical trials, and more. The company also provides a rationale for the recommendations it makes. Essentially, "we are trying to bring the expertise from the academic center ... to the community oncologist so that everyone gets the benefit as a patient regardless of where they are located," Kurnaz told GenomeWeb.

Massive Bio is also developing a tumor profiling service through which it will offer targeted gene panel sequencing — provided via partner sequencing centers — and analysis services using an internally developed informatics pipeline. That particular offering is scheduled to launch in 2016. The company also aims to create a communal knowledgebase that patients can opt to donate their information to and contribute to the creation of best practices treatment guidelines.

As part of the CDSS pilots, Massive Bio hopes to recruit at least one institution that will be willing to have the company's infrastructure installed locally and integrated with its internal electronic health record system, Kurnaz. The company also hopes to recruit several oncologists — on a first-come, first-served basis — who would be willing to demo the online version of the Massive Bio's platform for free.

Massive Bio plans to launch the onsite version of its solution after the pilot wraps, which will likely be sometime in June, Kurnaz said. Its on-demand option is already available. With regards to pricing, the company offers paid subscriptions to customers who chose to install and run the CDSS locally. It charges a one-time fee for installation and then a recurring subscription covers maintenance and basic reporting, and optional technical support.

Among other benefits, onsite installation makes it possible to link Massive Bio's system to the institution's electronic health record system, giving an oncologist the ability to compare a given patient's data to a wider pool of patients and identify similar cases that could bear on the current case, Kurnaz said. Also, clients have quick access to cancer care guidelines for all cases, while installed systems are customized to the oncology practice's needs and offer tools to track the outcomes of treatment decisions and reimbursements.

For local installs, the company will charge for one subscription per hospital but the pricing structure varies depending on how many oncologists will use the system, according to Kurnaz. A lower-end subscription would cover organizations with fewer than five oncologists, a medium subscription would cover five to 10 oncologists, and a higher-end subscription would be required if more than 10 oncologists would be using the system, she explained. The company is not disclosing the exact costs.

Massive Bio's on-demand option, on the other hand, is a lot less involved with no installation or implementation requirements or associated costs. Users access the solution via the company's web-based advisor interface. This option is tailored to oncologists looking for a second opinion on a particular case or seeking the services of a virtual tumor board, according to the company. All oncologists have to do is create accounts and upload their patients' information — with the appropriate approvals in place — to the company web-based interface and Massive Bio performs the analysis and generates a report including care recommendations and possible treatment strategies.

The company does have some guidelines in place with regards to the minimum amount of information that's required as input to the system for it to work — such as the patient's case history — but it is not limited to those inputs. If for example, the patient has a tumor profiling report either generated in house or by a third-party vendor like Foundation Medicine, Massive Bio's system can integrate those reports as well, Kurnaz said. Customers of the on-demand service are charged per report and there are no initial fees attached. It's also not intended as a practice-wide option, meaning that oncologists sign up for individual accounts. The company does not disclose the exact costs per report.

When it launches its NGS-based tumor profiling service next year, Massive Bio will charge customers on a per-report basis with no initial fee. That service will offer customers a targeted gene panel of 500 to 1,500 cancer genes — this includes 300 to 400 genes specifically selected by the company for its own targeted gene panel as well as genes from panels created by third party vendors. The company has currently selected and vetted about 10 sequencing providers that it will recommend to clients as part of the service, Kurnaz said.

Massive Bio has also put together best practices algorithms and workflows for analyzing sequencing results and detecting somatic alterations in tumor samples, and a database of curated annotation information from multiple commercial data and annotation providers. When its tumor profiling service launches, customers will be able to combine information from the company's service with their patients' data; however customers do not have to use Massive Bio's service to analyze their tumor samples as the company will accept reports generated by other service vendors, Kurnaz stressed.

Massive Bio's CDSS offering competes with solutions offered by health information platform vendors and existing clinical decision support system providers. However it believes it has more to offer. Health information platforms, for instance, are typically used to analyze outcome information, Kurnaz said, and don't necessarily provide insights in terms of treatment recommendations. Meanwhile, current clinical decision support systems providers don't have the benefit of a network of doctors that work with clients to examine patient cases individually and make personalized recommendations, she said. Also, these systems focus largely on chemotherapy as treatment strategy and don't offer next-generation sequencing or tumor profiling capabilities, she added.

The company will also have to contend with tumor profiling companies that, according to Kurnaz, are starting to see the value of integrating analysis results with patient case history and medical records. However, Massive Bio already has a system in place that can help with that task so that puts it a step ahead of its competitors, she said.

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