Clinical research has shown that the assay exhibited 100 percent sensitivity compared to culture-based testing methods, Hologic said.
With the NeoLSD MSMS kit, labs can leverage tandem mass spec technology, which reduces sample prep and analysis times, to run hundreds of tests per day.
Seksui's test is used in clinical labs to measure the percent concentration of HbA1c or the HbA1c fraction mmol/mol in human venous whole-blood and hemolysate.
The Cobas HPV Test is now approved for use as a primary screening test with BD's SurePath and Hologic's ThinPrep PreservCyt Solution.
The test, which uses automated reverse-transcription real-time PCR, expands the firm's menu of CLIA-waived tests for use in near-patient and point-of-care settings.
The assays can be used to screen for and diagnose anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis.
The agency cleared two of the firm's high-sensitivity troponin I assays for use on the Atellica IM and Advia Centaur XP/XPT immunoassay analyzers.
The Dip.io technology uses a smartphone's camera to capture high-quality images of a patient's urinalysis results and immediately send it off for clinical diagnosis.
The system is for high-throughput testing in central labs and the firm plans additional assays for infectious and sexually transmitted diseases.
The FDA cleared Roche's Elecsys BRAHMS PCT electrochemiluminescence immunoassay for an expanded use to aid in antibiotic therapy decision-making.