FDA has granted CLIA-waived status to the Alere Determine HIV-1/2 Ag/Ab Combo test, making it eligible for use in physician offices and clinics. The fourth-generation test enables faster detection, within days of infection.
Read MoreBio-Rad Laboratories has received FDA premarket approval for its Geenius HIV-1/HIV-2 supplemental assay, which can differentiate circulating antibodies to human immunodeficiency virus types 1 and 2 in whole blood, serum, and plasma. Requiring little training, the test produces results within 30 minutes.
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An international collaboration expects the handheld, battery-powered Freedom4 platform will enable rapid field deployment of a gold-standard molecular test.
Read MoreRunning on the popular GeneXpert system, Cepheid’s molecular diagnostic test for noroviruses promises accuracy and rapid detection.
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NIH funding leads to a new, low-cost molecular diagnostic instrument, with no electricity needed.
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