Biomarker Analysis For Covid-19 Clinical Trials: Discovery, Development And Assay Validation

Biomarker applicability would be the most appropriate and effective response for the ongoing coronavirus pandemic. This facilitates a better understanding of both the identification and infection process of the validated biomarker profiles for increasing the availability, accuracy, precision, and speed of the testing protocols of the Covid-19 pandemic.

Biomarker use has gained an importance particularly throughout the current phase of the Covid-19 pandemic as they are meant for enhancing the development as well as the approval of new and innovative pharmacokinetic drug candidates. Precisely, the clinical biomarkers also known as the measurable biological indicators have been widely employed for detecting the severity as well disease type. Such biomarkers can be widely employed for describing the observable characteristics of a particular medical condition. This facilitates the easy determination of optimal treatments according to the phenotype and genotype characteristics.

SARS-CoV-2 RNA genome currently is being widely employed as a key biomarker for facilitating the viral detection as well as aiding the preliminary process of the Covid-19 diagnosis. The viral proteins encoded by this genome could theoretically serve in the shoes of alternative biomarkers for viral detection. However, due to the degree of their protein complexity, significantly larger quantities as well as sample volumes are required. Thus, most of the viral proteins could serve as potential targets for the generation of the anti-viral drugs or biomarkers and aid the progress of the Covid-19 treatment regimen.

Prognostic biomarkers possesses either biological or clinical characteristics for providing information regarding the health outcome of the patients irrespective of the treatment regimen they are subjected to undergo. Such biomarkers have been frequently employed in the determination of severe medical conditions.

The clinical bioavailability are routinely employed across several hospitals for proposing, testing, and analysing for identifying severe Covid-19 cases. These serum biomarkers (creatinine, serum urea, cystatin C, etc) are usually found to be elevated in Covid-19 patients. This in turn triggers the monitoring of Covid-19 severity through the employability of serum indicators for reducing the overall mortality rate.

Inflammatory biomarkers have also been widely co-related for testing and evaluating the disease severity. For systemically reviewing the inflammatory biomarkers, levels of all subsequent biomarkers are tested. According to one of research findings, the levels of these biomarkers were found to be relatively higher in patients with severe illnesses. A novel cytokine biomarker known as LIGHT (encoded via TNFS14 gene) functions as an important cytokine biomarker possessing inflammatory actions. Furthermore, it participates in regulating immune responses across gut, lungs, and skin as a response to the viral pneumonia.

Out of all the predictors of the Covid-19 severity, one important one is the age. However, the pre-existing condition such as chronic kidney disorder, hypertension, lifestyle, etc also associate with the increased mortality. A fair and good biological age biomarker takes into consideration the lifestyle factors, genetics, toxic exposures, health conditions, etc. Epigenetic clock and glycan clock are attributed as the most prominent biomarkers for determining the biological age.

Furthermore, biobanking and biomarker analysis has been and will continue to be a key tool for several researches and developments taking place throughout the pandemic tenure.

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