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.
The FDA cleared Roche's Elecsys BRAHMS PCT electrochemiluminescence immunoassay for an expanded use to aid in antibiotic therapy decision-making.
According to the company, the designation will help speed potential FDA approval of the test, which uses Ceres' Nanotrap technology to diagnose Lyme disease.
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.
It is the first of three ePlex molecular multiplex panels for the diagnosis and management of bloodstream infections that can lead to sepsis.
Both recent FDA draft guidance and a new research framework encourage the use of biomarker diagnostics to assess Alzheimer's before symptoms emerge.
The new assay simultaneously detects four viral targets in donated blood plasma in a single sample and can add value to the biologics development space.
The Access hsTnI assay was cleared for use on Beckman Coulter's Access 2, Dxl, and the entire Access family of immunoassay systems. It was CE marked in late 2017.
The Early Sepsis Indicator is intended to provide clinicians information about sepsis and the risk of developing sepsis in patients in acute care settings.
The expanded clearance includes use of the test to assess a patient's risk of developing diabetes. The assay was cleared to run on the Afinion AS100 Analyzer.