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IO Informatics Partners with PROOF to Develop Risk Assessment Software for Clinical Use

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The Center of Excellence for the Prevention of Organ Failure, or PROOF Center, has tapped semantics-based software developer IO Informatics to build a web-based application that will be able to assess patients’ disease risk and make treatment recommendations.

This tool will be marketed along with blood tests that the Vancouver, BC-based PROOF Center is developing for heart, lung, and kidney disease and transplantation.

Specifically, IO will create a semantics-based application that will score individuals’ risk levels based on gene and protein expression data from biomarker-based tests being developed by PROOF and its collaborators along with clinical information from these patients. The system will also make therapy recommendations to help clinicians make appropriate treatment decisions.

Robert Stanley, IO’s president and CEO, told BioInform that the company will customize its Web Query software — one of the applications in its Sentient Suite of products — to fit the needs of the PROOF tests.

"We are extending some of the core technology, particularly technology underlying the automated query and reporting functions. For example, queries must be able to apply different weighting, inclusion, exclusion, and optional criteria for biomarkers applied in different contexts,” he explained.

IO is also modifying the system so that it can combine scores generated from multiple patterns observed in blood test results into single scores that will be presented to clinicians with additional visual and informational support, he said. For example, the application will provide visualization capabilities that will allow users to explore patients’ progress over time so that they can determine if they are getting better or worse.

This current collaboration extends a relationship between the two groups that began in 2007. Previously IO Informatics handled the data management and integration aspects of PROOF’s test development efforts, Stanley told BioInform.

Stanley’s firm has also worked with PROOF in the past to identify patterns that indicate which patients are at risk of organ transplant rejection, as well as to pull in related information from public resources such as DrugBank, Diseasome, and the Side Effect Resource, he said.

He also said that while IO Informatics’ regular clients are pharmaceutical and biotechnology companies, the company has worked with clinical research customers before.

However, this is the first time it is developing an application intended for use at the point of care, he said, adding that the company intends to offer the fruits of its collaboration with PROOF more broadly as one of the applications in its Sentient Suite.

“We see decision support for the point of care based on much more sensitive and specific screening tools … as a big area for growth over the next ten or fifteen years in the healthcare space,” he explained. “We see this as moving forward into that precision medicine direction that I think the whole healthcare market will be moving into.”

The PROOF Center is a not-for-profit organization that was set up with funding from the Canadian government. Its focus is on developing blood-based biomarker tests, primarily for heart, lung, and kidney diseases and transplants, using data from gene expression and plasma proteins, Janet Wilson-McManus, PROOF’s chief operating officer, explained to BioInform.

So far, the center has developed about 14 different tests in its primary areas — all of which are in various stages of verification, validation, and clinical implementation — and it plans to begin clinical testing for one of those tests later this year, she said.

The partners plan to have the software and the blood tests integrated and ready for clinical testing in the first quarter of 2013 although they haven’t determined which of PROOF’s blood tests will be used in these initial tryouts.

The partners have not yet finalized a commercialization strategy and price point for the tests and accompanying software. Both Wilson-McManus and Stanley said those decisions will be made with an eye toward lowering healthcare costs — specifically those associated with chronic heart, lung, and kidney diseases.

Besides IO Informatics, the PROOF Center collaborates with several other institutions and companies who contribute to various aspects of the blood test development process and who will also help with commercialization plans and ensuring that appropriate regulatory requirements are met when the tests are ready for use, Wilson-McManus said.