Close Menu

urinary tract infection

The firm is starting a trial that it anticipates will lead to an application for marketing clearance with the US Food and Drug Administration by next year.

The company aims to launch a CE-IVD-marked MALDI system in 2021 that will identify bacteria in urinary tract infections without requiring sample culturing.

Respiratory tract infections, particularly pneumonia, were the most common HAIs, accounting for a quarter of all HAIs in hospitals and a third in long-term care facilities.

The firm hopes to seek 510(k) clearance from the US Food and Drug Administration for its combined identification and antimicrobial sensitivity test by the end of 2019.

The quantitative immunoassay measures the concentration of a novel antibiotic, plazomicin (Zemdri), using the automated clinical chemistry analyzer Beckman Coulter AU 680.

As part of the deal, which is worth at least $3 million for the first five years, Primerdesign will develop and supply 384-well plate molecular assay panels for Genesis.

The company said it expects to submit its Acuitas assay for common causes of urinary tract infections to the US Food and Drug Administration early next year.

In recent months, three firms have received US Food and Drug Administration clearance for smartphone devices that allow patient-operated urinalysis testing.

The contract supports the development of a benchtop, fully automated platform and rapid tests to detect urinary tract infections and anthrax poisoning.

The firm is taking its in-home monitoring systems for COPD and cystic fibrosis, and its professional-use sepsis confirmation system through clinical trials.

Pages