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Clinical Biomarker Trends to Watch in 2023

The identification of novel clinical biomarkers is set to continue, with further research and investment in fields such as next-gen sequencing and miRNA targeting.

With the clinical biomarker field constantly advancing, biomarker testing is crucial to therapy selection for patients with advanced cancer.

While the incorporation of biomarker testing into clinical testing lags behind recommendations offered by bodies such as the US’s National Comprehensive Cancer Network, new alterations and improvements are continually helping to augment cancer identification approaches. 

As one example, biomarker use can enable patient stratification in trial enrolment, allowing study approval for a novel therapeutic whose side effects are a concern.

Here are some of the main trends to look out for in the emerging biomarker field in 2023.

Advances in New Biomarkers in Next-Gen Sequencing and Cancer Care

One area in which regulatory approval could provide a breakthrough is in precision medicine. 

As outlined in Targeted Oncology, next-generation sequencing (NGS) approaches could be used to identify drugs that patients should not be treated with in accordance with NCCN clinical practice guidelines for non-small lung cancer.

One area watched with interest by figures in the precision medicine field is the development of new NGS screening approaches, with applications in enabling the detection of germline approaches.

The detection of germline approaches is extremely important in the treatment of diseases such as breast, ovarian, and prostate cancer, since certain mutations have FDA-approved therapies. 

By better clarifying the properties of different cancers, new developmental biomarkers can help in informing clinicians of the appropriate research approach. 

CRSIPR Technology Advances in Cancer Biomarkers and miRNAs

Another area of the clinical biomarker field which could see new policy measures introduced is the remit of cancer biomarkers and microRNAS (miRNAs): small, single-stranded RNA molecules. 

As very small nucleic acids that regulate protein expression in cells, miRNAs can become dysregulated in tumours. 

Further down the line, a blood test could one day detect cancerous cells simply by targeting these exosomal miRNAs, as reported in Gene Engineering News. 

Recently, a team from Zhengzhou University has targeted miRNA-21, which is involved in the development and progression of several diseases including breast cancer.

Results from their study showed that MFS-CRISPR technology could be used to successfully detect miRNA with a mixture of similar sequences and with high sensitivity.

Regulatory approval in this area of research could see the differentiation approach used as a cancer diagnostic, assessing fluorescence intensity detected from clinical samples. 

Greater Uptake of Biomarkers in Oncological Clinical Trials

In 2000, only 20% of clinical trials for cancer used biomarkers to identify cancerous diseases. 

By 2018, more than half of oncological clinical trials used one or more biomarkers, and this figure is set to rise. 

Biomarker discovery is particularly useful in developing new early cancer screening methods to determine cancer prognosis and enable more effective targeted therapies. 

With comprehensive tumour profiling delivered through NGS screening, more precise treatment options can be developed for patients which target their specific cancer type and stage.

As NGS continues to become foundational in researching critical cancer fusions, the identification of novel clinical biomarkers is a promising strategy for the development of new cancer therapeutics. 

The next step for many of these burgeoning treatments is approval from regulators such as the FDA and the EMA. 

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