BD, Check-Points to Develop Assay for Carbapenem-Resistant Organisms

BD (Becton, Dickinson and Company) has announced a development and global distribution agreement with Check-Points for BD MAX assays that detect carbapenem-resistant organisms (CRO). As part of the agreement, BD will distribute the Check-Direct CPE Screen for the BD MAX assay (CE IVD) outside of the United States,* with Check-Points maintaining exclusivity in the Netherlands. Check-Points and BD plan to develop and commercialize a next-generation CRO assay for launch outside the United States in 2017 and in the America at a later time.
 
The Check-Direct CPE Screen for the BD MAX assay is a real time PCR kit for the detection of CRO from rectal swabs. The Check-Direct CPE Screen for the BD MAX identifies and differentiates the presence of the four most common carbapenemase genes: KPC, NDM, VIM and OXA-48-like (including OXA-181 and OXA-232). In three prospective European studies, the assay demonstrated overall clinical sensitivity and specificity of 98.5 percent and 96.8 percent, respectively.
 
“We have used the Check-Direct CPE Screen for BD MAX in routine screening for nearly two years,” said John Rossen, assistant professor of medical microbiology at the University Medical Center, Groningen (UMCG) in the Netherlands and scientific secretary of the ESCMID Study Group for Genomic and Molecular Diagnostics. “The assay on the BD MAX has improved our turn-around-time for CRO screening and has shown a very positive impact in our hospital.”
 
Carbapenem-resistant organisms represent a global healthcare-associated infection (HAI) concern. In 2014, the average carbapenem resistance for K. pneumoniae in Europe was approximately 7.3 percent, with some countries reporting as high as 62.3 percent. Rates of K. pneumoniae resistance to carbapenems range as high as 4 percent to 54 percent in other World Health Organization regions. In addition, the spread of CRO represents a unique antimicrobial stewardship challenge, with limited effective treatments and mortality rates as high as 54.3 percent. In response, the European Centers for Disease Control (ECDC) have launched active surveillance programs to assess CRO prevalence and monitor for outbreaks.
 
The Check-Direct CPE Screen for BD MAX assay is the latest offering in the BD MAX HAI portfolio, which includes IVD assays for the qualitative detection of Methicillin-resistant Staphylococcus aureus (MRSA), Staphylococcus aureus and Clostridium difficile (C. difficile). Together with other upcoming products on the BD Phoenix platform, BD will offer a comprehensive genotypic and phenotypic CRO solution to support clinical microbiology customers in their antimicrobial resistance programs.

BD is a global medical technology company that provides solutions to help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes. The firm is based in Franklin Lakes, N.J.
 
Check-Points is a privately owned diagnostics company in Wageningen, The Netherlands and a developer and marketer of molecular assays for gram-negative drug-resistant bacteria. Check-Points offers a range of in-vitro diagnostic and RUO products for the detection of carbapenemases, ESBLs and AmpCs.

*Product not available for sale in the United States.