This article was originally published in The Gray Sheet
Executive SummaryMeasles, mumps, and rubella tests run on oral specimens collected with the device "have comparable sensitivity and specificity to blood samples" based on preliminary study results published by Thomas Thieme, PhD, et al. in July 20 Journal of the American Medical Association, the company reports. Based on the results, Thieme et al. conclude that expanded clinical trials with the OraSure saliva collection system are warranted, and that oral fluid testing for antiviral antibodies "could provide an adjunct to the assessment of immunization coverage by questionnaires and medical records." Epitope has a premarket approval application pending at FDA for use of OraSure to collect HIV-1 test samples. If the PMA is approved, the company says it will seek approval of the system in testing for other diseases in light of the "promising results" of the JAMA study. Thieme is an investigator at Epitope and owns stock options in the company
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