Wave 80 Scientist Co-Authors Journal Article Highlighting Challenges, Opportunities in Clinical Laboratory Testing for Infectious Disease

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A new scientific publication appearing today highlights the promise of emerging testing technologies to improve individual patient outcomes and decrease the societal burden of disease, while also shedding light on the barriers to realizing the potential of new technologies, ranging from global regulatory process discord to outdated reimbursement practices to infrastructure-related product distribution inefficiencies in developing countries.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 AdministrationPATH, 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 technology is among a small group of highly promising technologies to allow better performance for existing clinical laboratory testing systems and new classes of products with new capabilities, such as suitability for use in low-resource settings.

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