OpGen Inc. (NASDAQ: OPGN) stock declined by 4.17% at the last close whereas the OPGN stock price gains by 11.23% in the pre-market trading session. OpGen, Inc. is a precision medicine business that uses molecular diagnostics and bioinformatics to aid in the fight against infectious illness.
OPGN stock’ Significant Update
OpGen confirmed that its Unyvero Urinary Tract Infection (UTI) Panel, which allows testing for a wide spectrum of pathogens as well as antibiotic resistance indicators directly from native urine specimens, has begun a clinical study.
The US Food and Drug Administration has previously approved the Unyvero System and Unyvero Lower Respiratory Tract panels. The Unyvero System employs highly multiplexed PCR technology to go from sample to answer. The Unyvero UTI panel is a brand-new application, and the overall trial design is quite similar to prior trials, with the goal of demonstrating the product’s treatment efficacy. According to FDA guidelines, the experiment will recruit over 1,500 prospective patient samples, which will be supplemented with archival, microbiological positive specimens.
The study’s primary goal is to evaluate test performance to the culture-based standard of care microbiology in terms of clinical sensitivity and specificity. All OpGen group firms, as well as external third-party CRO and laboratory service providers, will assist with study implementation. The results of this research are expected to be utilized to support a later FDA clearance application in the United States.
Faranak Atrzadeh, OpGen’s Chief Marketing, and Scientific Affairs Officer stated,
Urinary tract infections (UTIs) are one of the most prevalent infectious illnesses, and they may be quite dangerous. Complicated urinary tract infections (UTIs) are a significant cause of infection-related hospitalization in the United States, with approximately 3 million cases per year. They are also linked to increased morbidity and death. The right antibiotic choice and early and accurate identification of the pathogen(s) are essential for effective treatment of a cUTI (s). Subjectivity, specificity, prolonged time to results, and missing positive samples are among the drawbacks of culture-based laboratory testing in clinical practice.
