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BD, Check-Points Ink Agreement to Develop PCR Kit for Carbapenem-Resistant Organisms

NEW YORK (GenomeWeb) – BD today announced a development and global distribution agreement with Netherlands-based Check-Points that will integrate a Check-Points screen with a BD assay within a real time PCR kit that detects carbapenem-resistant organisms (CRO), a healthcare-associated infection, from rectal swabs.

Check-Points and BD plan to develop and commercialize a next-generation CRO assay for launch outside the US in 2017 and within the US later, BD said in a statement. Under the agreement, BD will distribute the kit outside of the United States, and Check-Points will maintain exclusivity in the Netherlands.

According to BD, the assay demonstrated overall clinical sensitivity of 98.5 percent and specificity of 96.8 percent in three prospective European studies.

The diagnostic kit 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).

"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. "The assay on the BD MAX has improved our turnaround time for CRO screening and has shown a very positive impact in our hospital." 

According to the European Center for Disease Prevention and Control, in 2014, the average carbapenem resistance for Klebsiella pneumoniae in Europe was approximately 7.3 percent, and some countries reported levels as high as 62.3 percent. The World Health Organization said rates of K. pneumoniae resistance to carbapenems range as high as 4 percent to 54 percent globally. Limited effective treatments are generally available for CRO and mortality rates have been reported as high as 54.3 percent.