NEW YORK—CLINiLABS has signed a master services agreement(MSA) to license NewCardio's QTinno cardiac safety analysis software, addingECG services to it drug industry portfolio.
The technology, which enables fully automated cardiac safetyanalyses in cardiac intensive and QT studies, will be used at CLINiLABS' unitin New York.
In addition, CLINiLABS, a contract research organization(CRO) that provides clinical drug development services to industry, has signeda services work order, including standard operating procedures (SOP) andvalidation kits, as well as professional services, so NewCardio, a cardiacdiagnostic and services company, can assist CLINiLABS in developing an ECG corelaboratory.
"This announcement is further evidence of the growingadoption of QTinno by innovative clinical trial service providers looking todeliver quality cardiac safety analysis with higher accuracy and lowerintrinsic variability in a timely and cost-effective manner," says VincentRenz, NewCardio's president and chief operating officer. "Our target customersare clinical trial service providers looking to deploy our proven technology toexpand services and grow market opportunities. For CLINiLABS, adding to itsavailable scope of services by utilizing QTinno accomplished these twoimportant goals."
While the financial terms of the agreement have not beenmade public, Renz says the MSA, which sets the foundation for a very integratedstrategic partnership between NewCardio and CLINiLABS, can effectively bedefined in two components.
"The first and current component is working together toaccelerate the internal organizational readiness for CLINiLABS to deliver highquality automated cardiac safety analysis, through QTinno, in a timely and costeffective manner as part of their core clinical service offerings," he says."This will be facilitated through the delivery of implementation kits andservices, from senior resources experienced in building and supporting worldclass ECG core labs."
Renz notes that the second component is the actual deliveryof quality cardiac safety analysis as an integrated component of early phaseQT/TQT studies for CLINiLABS customers.
"QTinno's license model is based on an ECG processingtransaction fee, which enables CLINiLABS to avoid any upfront license fee,which could be a detriment to market/customer adoption, as well as price theservices on an per-ECG basis, which is the current standard pricing model forthe delivery of cardiac safety services by ECG core labs, another means offacilitating market adoption," he says. "This license model incents bothparties to work closely together in securing and delivering quality cardiacsafety services, as the success of NewCardio/QTinno is tied directly to thesuccess of CLINiLABS in this initiative. CLINiLABS' long term plans include thedevelopment of ECG core lab services based on QTinno's automation, enablingthem to provide a low-cost solution for ECG analysis for all phases of clinicaldrug development."
The relationship will enable CLINiLABS to compete in themarket for ECG core laboratory services by providing the professional servicesneeded to integrate ECG core lab functions into CLINiLABS' existing core datacenter, which currently serves clinical trials in 33 countries.
Dr. Gary K. Zammit, president and CEO of CLINiLABS, pointsout that NewCardio's QTinno, coupled with its team's history and expertise indelivering cardiac safety services to leading pharmaceutical companies, "hasgiven us an incredible opportunity to expand our service portfolio and delivervalue to our clients. We can now provide a differentiated and low cost solutionfor ECG data analysis to an industry that has been seeking a meaningfulalternative to existing methods for some time."
As Renz points out, advantages of QTinno are in therobustness of the technology, presented through the proprietary approach andalgorithms, as well as the integrated workflow application and experiencedservices organization built by NewCardio to support its customers.
"The underlying technology, driven by our virtual vectormagnitude lead, iterative curve fitting algorithm and confidence factor hascontinuously delivered results which match or exceed the so-called manual 'goldstandard,' with significantly lower intrinsic variability, shortertimelines/turnaround and lower cost," he says. "The virtual vector magnitudelead presents a lead which contains information from all lead, all beatsthereby providing QTinno access to data from the ECG which has always beenknown to be available, but inaccessible to the human eye.
"QTinno is different from the other solutions in that itdoes not simply automate the manual and/or semi-automatic approaches (i.e.single lead tangent, global median beat, etc.), which would result in applyingtechnology to a inaccurate process, thereby receiving inaccurate result, onlyfaster," he adds.
Ultimately, Renz says his company will measure its successwith the success of CLINiLABS in their ability to "secure and deliver qualitycardiac safety analysis services in a more timely and cost effective manner, asan integrated services offering, to their drug development clients."