Assay Development Services in Personalized Medicine: Customized Solutions for Individualized Therapies

Assay Development Services

Today, high throughput analytical assay development such as DNA sequencing has revealed numerous factors and mechanisms in inter-individual variation. Such insights have developed questions about optimal treatment or monitoring of disease and medical conditions. Hence, the emerging consensus suggests a personalized approach to treat, prevent, and monitor disease conditions.

However, personalized medicines have numerous challenges, especially related to regulatory concerns. The primary debate revolves around personalized medicines, such as transplant therapy, which are very expensive. Hence, the current article discusses the role of individualized therapy in the drug discovery and development process. However, assay development and validation will remain crucial for advancing personalized medicine. 

Assay development services for individualized therapies

Personalized medicine stems from the notion that certain drug products will be more beneficial for patients with specific genetic profiles. For example, drugs like warfarin work for patients with specific genetic profiles. Hence, modern research is focused increasingly on the influence of genetic profiles on the response against drugs and interventions. This advantage has helped tests move towards personalized disease surveillance and personalized disease prevention protocols. 

Personalized medicine identifies the genetic profiles of specific patients and then crafts therapy unique to those targets. Immunotherapy is another example of personalized medicine emerging in cancer treatment. Immunotherapy aims at priming the immune system to attack the cancer cells. Today, personalized medicine is focusing on exploiting immunotherapy that targets genetic alterations. These genetic alterations can induce an immune response. Generally, this type of immunotherapy involves harvesting T cells from the patients and then modifying those cells to recognize and target antigens present in the tumor cells. 

Individuals with disease recurrence or susceptibility to a disease require regular monitoring. Personalized medicine focuses on identifying individual thresholds as opposed to population thresholds to generate evidence or signs of that particular medical condition. Population thresholds come from epidemiological data and surveys. However, personal thresholds are specific to that individual observed and collected over time. 

Using genetic information to deliver personalized disease prevention strategies is widely adopted in research settings. Personalized prevention strategies based on genetic information can decrease the likelihood of disease development and complications compared to standard screening and treatment strategies. 

Despite the benefits and applications of personalized medicine, there are very few examples of personalized medicine utilization in the clinical community. Intervention matching trials, adaptive clinical trials, and N-of-1 clinical trials are emerging personalized medicine strategies. The development of newer and more robust personalized medicine strategies can help expand the reach of personalized medicine. 

Additionally, recent research has focused on new territories in personalized medicines. These recent developments include patient-derived cells for identifying the best therapy for an individual, the development of personalized digital biotherapeutics, individual diagnostic and monitoring methods to identify signs of medical conditions, and personalized medicine to treat patients with fertility problems. 


Treating individuals with personalized medicines may become a necessity in the future. The advent and availability of modern technology, such as proteomics and DNA sequences, has helped scientists identify inter-individual variation and treat these unique differences at a personal level. 



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