Diagnostics company Cepheid disclosed on Tuesday the receipt of clearance from the US Food and Drug Administration (FDA) for expanded claims for the 'super bug' Xpert Carba-R molecular test to aid clinicians in determining appropriate therapeutic strategy for pure colony specimens.
The company said the Xpert Carba-R is an on-demand molecular test for rapid and accurate detection of carbapenemase-producing gram-negative bacteria primarily responsible for the increasing spread of Carbapenem-resistant Enterobacteriaceae (CRE) infection in the US.
In addition, the additional claims extend use to analysis of perirectal swab specimens and allow use of Xpert Carba-R test results to guide therapeutic strategies for pure colonies, according to the company.
Detection and differentiation of high-risk patients with Xpert Carba-R can alert clinicians and infection preventionists quickly to the presence of gene sequences associated with carbapenem non-susceptibility in gram-negative bacteria, including Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter baumannii, concluded the company.
Sanofi receives FDA complete response letter for tolebrutinib in progressive MS
Aqualung Therapeutics' Phase 2a lung fibrosis study approved by US FDA
AstraZeneca secures US Breakthrough status for Enhertu in early breast cancer
Shield Therapeutics wins FDA approval to expand ACCRUFeR use to adolescents
ECO Animal Health Group secures EU approval for ECOVAXXIN MS
Hansa Biopharma submits imlifidase Biologics License Application to FDA
T-MAXIMUM Pharmaceutical receives IND approval to start Phase II trial of MT027 for rGBM
Alvotech and Teva secure US launch date for Eylea biosimilar AVT06
Egetis initiates rolling US NDA for Emcitate in MCT8 deficiency
Abbott's Amplatzer Piccolo Delivery System receives US FDA clearance and CE Mark
Amphix Bio announces initial closing of USD12.5m seed financing round
BiBBInstruments reports additional US orders during targeted EndoDrill GI launch
Sanofi's efdoralprin alfa receives EU orphan designation for AATD-related emphysema
Black Buffalo partners with Sanova to support regulatory strategy and scientific innovation
Nicox completes key data package for NCX 470 NDA submissions