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Medical Diagnostic Test Performance Statistics Made Simple

(PRWEB) August 29, 2012

A recent iData Research report predicts the U.S. IVD market will exceed $9.5 billion by 2017 (“U.S. Market for In Vitro Diagnostics 2011”). This forecasts a significant growth rate in the clinical diagnostics sector that includes immunochemistry, molecular diagnostics, blood screening, hematology, and point-of-care testing. With the expansion of new products and technologies in an already thriving market, a fundamental understanding of the way that clinical laboratory diagnostic test performance is evaluated is essential for anyone tasked with making well-informed business decisions.

To help make those key test performance values easier to grasp, BioMarket Consulting, LLC will post a series of white papers authored by Dr. John Alsobrook, Chief Science and Technical Officer with the life sciences marketing group and a former CEO of Exagen Diagnostics, Inc. Dr. Alsobrook sees a widespread conceptual disconnect between test statistics and related business decision-making. Professionals working outside the research and development environment comprise the majority of those associated or employed with life science and biomedical companies, including venture capitalists and other investors, personnel in sales and marketing, finance, business development, customer service, and even customer clinicians and patients. For them, the statistical terms and values in common use tend to remain abstract. Furthermore, some common measurement terms are used so routinely that an initial misinterpretation has resulted in their meaning having been continuously misrepresented or lost altogether.

The most commonly seen performance measurements associated with in vitro diagnostic tests are sensitivity, specificity and accuracy. These numbers are often misunderstood and are not always fully representative of test performance. In Dr. Alsobrook’s first paper, these terms are introduced and explained in basic language. In his words, “The only math skills you’ll need are counting, adding, and dividing.” In subsequent papers, he will address other common terms of diagnostic performance measurement in the hope of alleviating confusion and providing tools for knowledgeable decision-making. You can follow Dr. Alsobrook’s series at

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