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Artificial Intelligence Added to Medloom Clinical Decision Support System
Junction City, Kansas

Lead Horse Technologies has announced the addition of artificial intelligence (AI) technology to its Medloom clinical decision support system. Medloom runs on the InterSystems CACHE high-performance object database platform. CACHE provides the high performance, rapid development environment and advanced features needed for the real-time decision support that characterizes the Medloom system, according to John M. Armstrong, Ph.D., Lead Horse Technologies Chairman and CEO.

Dubbed Ardvarc, the new patent-pending AI software is already viewed by some industry experts as a potential leap forward in drug safety. "Lead Horse Technologies is unique. They've developed terrifically novel software that, in my opinion, would give valuable early signals about drug safety issues... signals that just haven't been available until now," said Charles L. Bennett, MD, Ph.D. and the Center of Economic Excellence Endowed Chair in Medication Safety and Efficacy at the South Carolina College of Pharmacy.

"There is no more important issue than pharmaceutical safety, but many people don't really pay attention to it," Bennett continued. "Most clinicians assume that drugs are vetted by the Food and Drug Administration (FDA) or the pharmaceutical manufacturer. Simply stated, the manufacturer has a difficult time and, while the FDA tries its hardest, there just aren't enough people to do the work completely."

Surveillance Results in Seconds, Not Months or Years

Ardvarc is based on an AI technology known as Association Rule Discovery (ARD). Lead Horse partnered with a Northern Ireland-based company, Sophia Search, Ltd., best known for its award winning document search and discovery technology, to enhance Medloom with this proprietary AI component. Basically, Ardvarc vets data stored in safety registries, including the FDA's Adverse Event Reporting System (AERS) to discover significant relationships between drugs, or combinations of drugs, and adverse events in real-time mode, according to Armstrong.

"In mid-2007, the FDA concluded that the structure of their AERS database was basically unusable and its content insufficient for its purpose. As a result, the FDA formed the Sentinel Initiative in 2008, inviting private companies to join in public-private partnerships that will complement existing systems that the FDA has in place to track reports of adverse drug reactions (ADRs) linked to the use of its regulated products," Armstrong said. "Subsequently, the FDA unveiled its 'Safe Use Initiative' in 2009 to target preventable harm from medication use," Armstrong added.

In the first run of Ardvarc against a three-month FDA dataset including roughly 50,000 reports, the AI system successfully discovered the same "substance-adverse event" relationship rule in a single run that required time- and labor-intensive efforts by researchers covering years of patient cases to discover. The quality of the findings discovered by Ardvarc was matched by those published in the peer reviewed literature, according to Armstrong, emphasizing that Ardvarc discovers meaningful red flags and weeds out the false positives that no healthcare professional has the time to read or analyze.

"The implications of this accomplishment regarding the prevention of hospitalization or loss of human life and its associated costs to the payer, the provider, and the patient are very significant," said Armstrong. "The next step," he continued, "is to integrate Ardvarc technology with Medloom's own AERS data repository to move from real-world safety surveillance, available using the FDA's data, to real-time, real-world surveillance."

"While many companies already have pharmacovigilance and drug safety surveillance systems, none have the real-time AI technology offered by Ardvarc," Armstrong said. "We're looking forward to collaborating with health IT companies and to bringing this technology to market as rapidly as possible. The costs of serious ADRs -- those resulting in hospitalization or death -- are huge, both nationally and globally," he noted. "If our initial results with this AI technology are an indication of Medloom's ability to help our company accomplish its mission of saving lives and reducing healthcare costs, we are very excited about the potential to better the human condition through collaboration."

"The Lead Horse Technologies strategy of combining AI technology, Medloom's clinical decision support facilities, and the power of CACHE epitomizes the breakthroughs in healthcare technology that are being delivered by our application partners globally," said Paul Grabscheid, InterSystems Vice President of Strategic Planning.

About Lead Horse Technologies

Lead Horse Technologies is a drug safety information technology company using health IT to develop products for other health IT companies and end-users in support of positive benefit/risk profiles, lower pharmacy costs, and safer drug launches, whether in the clinical trial phase or in the post-marketing environment. We support the practice of personalized medicine and work to reduce the rates, severity, and costs associated with adverse drug reactions (ADRs). The Medloom decision support system is our primary product and is designed to answer ADR queries using content from multiple data sources, including drug labels, as well as from pharmacovigilance registries. Please go to www.leadhorsetech.com for additional information.

About InterSystems

InterSystems Corporation is the worldwide leader in software for connected healthcare. With headquarters in Cambridge, Massachusetts, and offices in 24 countries, InterSystems provides advanced software technologies for breakthrough applications. InterSystems CACHE is a high performance object database that makes applications faster and more scalable. InterSystems Ensemble is a seamless platform for integration and the development of connectable applications. InterSystems HealthShare is a platform that enables the fastest creation of an Electronic Health Record for regional or national health information exchange. InterSystems DeepSee is software that makes it possible to embed real-time business intelligence in transactional applications. For more information, visit InterSystems.com.

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