OpGen has entered into a global supply agreement to use Thermo Fisher Scientific’s real-time PCR technology in the company’s Acuitas® AMR Gene Panel Tests. The first test, the Research Use Only (RUO) AMR Gene Panel u5.47, is available for infection control purposes and pharmaceutical surveillance research. OpGen is planning clinical trials to support regulatory submissions for broader clinical use in patients with complicated urinary tract infections (cUTI).
Recent studies have indicated that antimicrobial resistant infections currently claim 50,000 lives each year across the United States and Europe alone, with many hundreds of thousands more dying in other areas of the world. OpGen is addressing this global threat with innovative technologies that enable rapid and precise identification of antimicrobial resistance.
Effective, targeted antimicrobial treatment is of critical importance in patients with cUTI and other serious infections as the emergence and spread of antimicrobial-resistant organisms increase. There are an estimated 400,000 to 800,000 patients each year in the U.S. with cUTI, and approximately half are at risk for multidrug-resistant infections. Complicated UTI continues to be a major cause of hospital admission, morbidity, mortality and excess health care costs as a growing number of infections are healthcare associated in origin.
The new Acuitas AMR Gene Panel u5.47 RUO test detects 47 gene targets which span 600 subtypes and convey resistance to 9 classes of antibiotics directly from urine and isolated colonies. From urine specimens, the Acuitas AMR Gene Panel u5.47 RUO will semi-quantitatively detect the most common bacterial causes of cUTI (E. coli, K. pneumoniae, P. aeruginosa, P. mirabilis, E. faecalis). Test results are provided in under three hours compared with traditional microbiology methods, which can take two to three days.
In an easy-to-use laboratory protocol, the Acuitas AMR Gene Panel u5.47 RUO test will incorporate Thermo Fisher’s TaqMan® Fast Advanced Master Mix and TaqMan® Probes for quick, multiplexed gene detection. The genetic results may be analyzed in OpGen’s Acuitas Lighthouse® Knowledgebase bioinformatics system to help healthcare providers rapidly and accurately identify antimicrobial resistance.
“We are pleased to expand our relationship to include these market-leading real-time PCR technologies. In 2017 we entered into an agreement to use the QuantStudio™ 5 Real-Time PCR System. The combination of these technologies, along with OpGen’s innovative solutions, will aid laboratories and healthcare providers in the fight against antimicrobial resistance,” said Evan Jones, Chairman and CEO of OpGen. “Thermo Fisher’s market-leading position in PCR and its global installed base makes it an ideal partner for our Acuitas Rapid Test.”
TaqMan® Fast Advanced Master Mix, TaqMan® Probes and QuantStudio™ 5 Real-Time PCR System are for research use only and are not intended for diagnostic procedures. – Medical Buyer Bureau