Antibiotic-Resistance-Screening Diagnostic Wins CE Mark

Novodiag CarbaR+, a test for detecting carbapenemase-producing enterobacteriaceae (CPE) in just 80 minutes, has been issued CE Marking for an IVD. CPE are bacteria that are resistant to the carbapenem class of antibiotics, and early detection could help clinicians quickly identify affected patients.
 
“The rapid diagnosis of CPE enables early-decision making for the selection of appropriate treatment (with or without antibiotics) at an early stage for the infected patient, increasing the likelihood of positive outcomes,” Tuomas Tenkanen, CEO of Mobidiag, the developer and marketer of Novodiag CarbaR+, told MD+DI. “Additionally, once introduced into a health system, superbacteria can rapidly disseminate within and across medical institutions, so early detection allows infected patients to be isolated and treated accordingly to avoid the spread of infection.”
 
Novodiag CarbaR+ also identifies a plasmid-mediated resistance to colistin, which the company said is considered the drug of last resort for many infections. The test combines multiplex qPCR and microarray in one single test for the most common carbapenemase-producing enterobacteriaceae and colistin resistance markers. The complete panel includes the detection of the following genes: KPC, NDM, VIM, IMP, OXA-23, OXA-24, OXA-48/181, OXA-51, OXA-58, and MCR-1.
 
Tenkanen said that “the excessive use of antibiotics has given rise to multidrug-resistant organisms, making antibiotics less and less effective. A simple routine case of bacterial infection can then result in a medical emergency, with no efficient drugs available for treatment. Antibiotic microbial resistance (AMR) already presents a serious social and economic burden. It is estimated to be responsible for 25,000 deaths per year in the EU alone and 700,000 deaths per year globally. Inaction is projected to cause millions of deaths globally: it has been estimated that AMR might cause more deaths than cancer by 2050, according to A European One Health Action Plan against Antimicrobial Resistance (AMR) by the European Commission). In 2015, 13/38 of studied European countries reported inter-regional spread of an endemic situation for CPE, compared with 6/38 countries in 2013.”
 
Novodiag CarbaR+ complements Mobidiag’s existing portfolio for screening antibiotic resistance, which includes (Amplidiag CarbaR+VRE and Amplidiag CarbaR+MCR. “Our two platforms meet the differing needs of a broad range of customers based on volumes and hospital settings: Amplidiag by batch (large volumes, contact patients), Novodiag for on demand (small volumes),” he said. “Novodiag CarbaR+ compliments the existing multiplex portfolio, allowing on-demand testing for any patient at any time to detect rapidly the most relevant carbepenemases and colistin resistance.”
 
Mobidiag’s technology is "mature and based on global expertise in house and extensive investment," Tenkanen said. “It brings together all factors needed for success – assay development, chemistry, engineering, optics, software, and manufacturing capability. Novodiag allows for the rapid, direct analysis by combining multiplex qPCR and microarray technologies, which allows a large number of targets to be detected simultaneously from one single patient sample.”
 
The company is currently focusing on direct sales and distribution agreements in Europe as well as its new joint venture with Autobio for the Greater China Region. “With this recent CarbaR+ news and also the recent announcement of our joint venture with Autobio in China, we are very excited for the future. We plan to accelerate the development of further assays for the Novodiag system and enhance its manufacturing capabilities, as well as continuing to facilitate Mobidiag’s commercial expansion in Europe through direct sales and distribution agreements, and in China through our JV with Autobio,” said Tenkanen. “At present there is no plan that has been publicly announced for the United States.”