The Lantern Project will screen for patients who may be suffering from Gaucher disease, Fabry disease, Pompe disease, MPS I, or ASMD, and offer confirmatory DNA testing.
The IVD kit is for use with a mass spectrometer and quantitatively measures and evaluates traditionally screened amino acids and measures up to 51 analytes.
Siemens Healthineers received FDA clearances for several assays, including separate allowances for tests using hemoglobin A1c, troponin I, and procalcitonin biomarkers.
Revenues from the company's diagnostics business and discovery and analytical solutions business each grew 10 percent on an organic basis.
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.
Angle this week announced its preliminary financial results for the fiscal year ended April 30.
The assays can be used to screen for and diagnose anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis.
PerkinElmer will offer providers and patients screening for ASAH1 mutations through its PerkinElmer Genomics laboratory unit.
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 partners will test PerkinElmer's Vanadis NIPT platform on samples from 2,650 women to determine detection and false positive rates.