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New Journal Article Highlights Challenges, Opportunities for Next-Generation Point-of-Care Testing Technologies

Dr. Laura Mazzola, Wave 80’s Senior Vice President of Global Initiatives, co-authors analysis of impact and opportunities for POC diagnostics.

San Francisco, California, March 7, 2012 — A new scientific publication appearing today highlights the promise of emerging point-of-care testing technologies to improve individual patient outcomes and public health, while also shedding light on the barriers posed by a host of barriers ranging from global regulatory process discord to outdated reimbursement practices to infrastructure-related product distribution inefficiencies in developing countries.

The article, written by Wave 80’s Dr. Laura Mazzola along with co-authors from the U.S. National Institutes of Health, the World Health Organization, the U.S. Food and Drug Administration, PATH, Northwestern University’s Kellogg Graduate School of Management, and others, appears in the prestigious Journal of Infectious Diseases.

“From treatment of acute coronary syndrome to long-term management of diabetes, point-of-care diagnostic testing has already had an enormous impact on the practice of medicine. Now, thanks to emerging technologies for analyzing readily obtainable samples like blood and sputum, the benefits of high-performance, while-you-wait testing can be extended to two diseases of tremendous global importance: HIV and tuberculosis.”

The JID article focuses on tuberculosis and HIV not only because of the enormous morbidity and mortality associated with these two diseases—particularly in the developing world—but also because successful treatment of both HIV and TB hinges on a type of testing known as molecular diagnostics. Molecular diagnostic testing directly analyzes pathogen genomic material—HIV RNA in the bloodstream, and TB bacterial DNA and RNA in sputum.

Molecular diagnostic testing requires specialized assay methods which, until recently, have required expensive, lab-scale equipment and highly trained operators. Wave 80’s EOSCAPE is at the forefront of a new class of molecular diagnostics that is compact, fast, and easy to use. EOSCAPE pioneers powerful new technologies for sample preparation and assay processing—with tremendous benefits for patients through enhanced disease management at the point of care.

About Wave 80

Wave 80 Biosciences develops next-generation molecular diagnostics instruments and consumables for hepatitis C, hepatitis B, HIV/AIDS, and other human health conditions. Distinguished by a novel one patient-one test usage model, best-in-class performance, and a superior value proposition, Wave 80’s pipeline products address unmet needs of diverse patient populations worldwide in the high-clinical-value molecular diagnostics segment of the clinical laboratory testing systems market.