Strengthening OpGen’s entry into the United States market, the companies have entered into an agreement to commercialize a new solution for the detection of multidrug resistant bacterial pathogens based on QIAGEN’s EZ1 Advanced XL automated nucleic acid purification instrumentation (EZ1) and kits for the United States. The EZ1 will be utilized in the test workflow for the Acuitas AMR Gene Panel u5.47 products.

The AMR Gene Panel family of rapid diagnostics tests has been designed to detect and identify multidrug-resistant bacterial pathogens in urine and bacterial isolates in approximately two hours. The test was developed for use with the Acuitas Lighthouse Software for predicting antibiotic resistance and high-resolution pathogen tracking. The AMR Gene Panel u5.47 and the Acuitas Lighthouse Software are currently available for Research Use Only (RUO).

Under the terms of the agreement, OpGen will purchase EZ1 instruments and reagent kits from QIAGEN and sell or place them with customers in the United States for use with the Acuitas AMR Gene Panel. The EZ1 is a Class I Medical Device listed with the Food and Drug Administration (FDA) that provides full automation with sample preparation throughput of up to 14 samples per one-hour run.

QIAGEN is the global leader for nucleic acid sample preparation with a full line of instruments and reagents including the EZ1, the QIAcube, and the QIAsymphony fully integrated automation. There are thousands of EZ1 instruments currently used in laboratories worldwide.

OpGen chairman and CEO Evan Jones said: “We are pleased to collaborate with QIAGEN to further strengthen our AMR Gene Panel offering.

“The EZ1 provides best in class nucleic acid purification technology, and QIAGEN’s extensive global commercial capabilities and diagnostic expertise should provide multiple opportunities for collaboration in the future.”

QIAGEN molecular diagnostics business area senior vice president Thierry Bernard said: “We are pleased that OpGen is incorporating the EZ1 as part of their AMR Gene Panel test offering,”

“The partnership further expands the menu for EZ1 and adds a new and rapid diagnostic solution in the crucial fight against AMR.”

Source: Company Press Release