The lab will test samples reimbursed only by the federal government. Attis expects it will test a baseline of 3,000 toxicology samples per month by the end of 2018.
ProAxsis and a US-based biotechnology company codeveloped the assay as part of an ongoing collaboration. ProAxsis has made its first commercial sale of the test.
The Atellica assay's capability to assist with antibiotic therapy decisions can help address the rising problem of antibiotic resistance, Siemens said.
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.
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 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 firm will manufacture its Logix Smart mycobacteria tuberculosis assay at its ISO-certified facility in Utah but will not seek FDA approval at this time, it said.
The system combines proprietary dry slide technology with digital imaging capabilities and the ability to run two separate lab tests simultaneously.
This drug is the first FDA-approved IDH1 inhibitor and will be used to treat adult patients with relapsed or refractory acute myeloid leukemia.
Saladax is asking the FDA review the kit for the total measurement of risperidone in patients to monitor drug levels order to aid in managing patient adherence.
In June, the FDA cleared tests for a broad range of conditions, including Group B strep, systemic rheumatic disease, and chlamydial or gonococcal urogenital disease.
The FDA cleared Roche's Elecsys BRAHMS PCT electrochemiluminescence immunoassay for an expanded use to aid in antibiotic therapy decision-making.
The approval of the Philips Intellisite Pathology System by the Ministry of Food and Drug Safety follows US FDA clearance last year.
The FDA said that pooled testing of donations using a screening test that it has licensed is a sufficient method for complying with its testing regulations.
MGI received medical device certification clearance for its MGISEQ-200 and MGISEQ-2000 instruments.
In the last year, both Sciex and Thermo Fisher have launched clinical platforms, but whether they will prove commercial successes remains to be seen.
It is the first of three ePlex molecular multiplex panels for the diagnosis and management of bloodstream infections that can lead to sepsis.