OpGen Inc. (OPGN) stock prices were down by 4.17% as of the market closing on October 1st, 2021. This brought the price per share down to USD$2.76 at the end of the trading day. Subsequent premarket fluctuations have seen the stock surge by 17.39%, bringing it up to USD$3.24.
OPGN Stock Starts Clinical Trials
September 30th, 2021 saw OPGN stock announce the initiation of its clinical trial for the Unyvero Urinary Tract Infection (UTI) Panel. The panel will allow for the testing of a broad range of pathogens, as well as antimicrobial resistance markers directly from native urine specimens. The Unyvero System and Unyvero Lower Respiratory Tract panels have both been cleared by the United States Food and Drug Administration. The sample-to-answer Unyvero System makes use of the highly multiplexed PCR technology.
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Unyvero UTI Panel
The Unyvero UTI panel is a novel application, with the overall trial design being very similar to previous studies. It aims to demonstrate the product’s clinical performance. As per the FDA’s guidance, the trial is aiming to enroll more than 1,500 prospective patient samples. These samples will be consolidated and complemented with archived, microbiology positive specimens. The primary endpoint of the study will be assay performance as defined by clinical sensitivity and specificity, as compared to culture-based standard of care microbiology.
About OPGN Stock’s Clinical Trials
The clinical trial will be conducted across multiple sites in the United States. Unyvero instrument setup and site initiation visits are ongoing following the Institutional Review Board’s approval of the study protocol at the trial sites. This is hoped to set the company up to meet requirements laid out by the U.S FDA. Study execution will be scaffolded by all of the OPGN stock’s group companies, as well as by external third party CRO and lab service providers. Data from the study will be used to support the subsequent submission to the FDA for clearance in the United States.
Scope of UTIs
UTIs are a leading infectious disease in the United States, with potentially devastating effects on healthcare. Roughly 3 million cases are observed in the United States each year, with complicated UTIs resulting in infection-related hospitalizations and associations with higher morbidity and mortality.
Future Outlook for OPGN Stock
The company reported a promising quarter, consolidated by the expanded scope of opportunities afforded by the start of clinical trials. OPGN stock is keen to accelerate the development, commercialization, and proliferation of its proprietary treatments in a bid to usher in unprecedented growth. Current and potential investors are hopeful that management will be able to leverage the resources at their disposal. This is hoped to facilitate significant and sustained increases in shareholder value.