Close Menu

FDA clearance

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 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.

With the new clearance, DiaSorin's test can be run on genital swabs, and all cutaneous and mucocutaneous swab samples, as well as CSF samples.

The test is intended for use as the initial screen in the two-step testing process recommended by the CDC for detecting antibodies against B. burgdorferi.

Physicians can now use the Dako PD-L1 IHC 22C3 pharmDx assay to identify cervical cancer patients who may benefit from the anti-PD1 immunotherapy.

The test is Micronics’ first to receive FDA clearance, and the company is pursuing CE marking for it and the PanNAT system.

The firm's bacterial panel detects species of bacteria in a patient's blood in roughly five hours after sample collection.

Echo Lumena is Immucor's fifth-generation immunohematology instrument, and with the fully automated NEO platform, they offer a standardized workflow solution for laboratories.

Hologic's device will potentially increase sensitivity for cervical disease detection in US laboratories that employ the firm's automated imaging system.

Pages