Home 5 Clinical Diagnostics Insider 5 Faster Tests Needed to Diagnose Infectious Diseases

While advances in nucleic acid–based amplification technologies have contributed to improved pathogen detection, infectious disease diagnostics are still failing to return results fast enough to meet clinical need. Quicker, more meaningful results have the potential to significantly enhance outcomes in terms of improved antibiotic stewardship, more personalized patient care, and lower health care costs. “With the current state of diagnostic testing, we are handicapped, making decisions based on limited or nonspecific information—in situations ranging from helping individual patients to identifying broader public health threats,” said Angela M. Caliendo, M.D., Ph.D., from Brown University in Providence, R.I., and lead author of the Infectious Diseases Society of America’s (IDSA) November 2013 report Better Tests, Better Care: Improved Diagnostics for Infectious Diseases. “It is critical,” she says in a statement “that we not only invest in the development of new diagnostic tests, but that we also work to ensure these new tests are fully integrated into patient care.” The report calls for enhanced fiscal incentives and streamlined regulatory pathways to make diagnostics research and development more viable for companies, particularly for priority tests aimed at meeting the greatest unmet clinical needs. Specifically, IDSA calls for loosened regulation to access critically needed specimens for […]

While advances in nucleic acid–based amplification technologies have contributed to improved pathogen detection, infectious disease diagnostics are still failing to return results fast enough to meet clinical need. Quicker, more meaningful results have the potential to significantly enhance outcomes in terms of improved antibiotic stewardship, more personalized patient care, and lower health care costs. “With the current state of diagnostic testing, we are handicapped, making decisions based on limited or nonspecific information—in situations ranging from helping individual patients to identifying broader public health threats,” said Angela M. Caliendo, M.D., Ph.D., from Brown University in Providence, R.I., and lead author of the Infectious Diseases Society of America’s (IDSA) November 2013 report Better Tests, Better Care: Improved Diagnostics for Infectious Diseases. “It is critical,” she says in a statement “that we not only invest in the development of new diagnostic tests, but that we also work to ensure these new tests are fully integrated into patient care.” The report calls for enhanced fiscal incentives and streamlined regulatory pathways to make diagnostics research and development more viable for companies, particularly for priority tests aimed at meeting the greatest unmet clinical needs. Specifically, IDSA calls for loosened regulation to access critically needed specimens for test validation, funding for outcomes research to demonstrate the clinical value of diagnostic tests, appropriate reimbursement, and education for providers. For more information on emerging technologies for the diagnosis of infections, please see Inside the Diagnostics Industryon page 5.

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