Advancement of Personalized Treatment Strategies in Oncology Companion Diagnostics and Biomarkers 

Thanks to advances in genetic research and next-generation sequencing, doctors are transitioning from a generalized “one-size-fits-all” approach of the past towards treatments customized to each person’s unique genetic makeup called precision medicine. 

Cancer isn’t a single disease; it’s a complex, personal condition, shaped by each person’s unique biology and as a result, traditional cancer treatments often fall short. For decades, cancer has been treated using a combination of four main conventional methods: surgery to remove tumors, radiation and chemotherapy to kill cancer cells throughout the body, and immunotherapy to boost the body’s immune system to fight cancer. By studying the genetic changes fueling a person’s cancer, doctors can tailor treatments that work better and are safer. 

Companion diagnostics are specialized tests that help doctors determine which therapies are most likely to work for a specific patient based on their genetics. By identifying key biomarkers (molecules in blood, tissue, or other bodily samples) these tests guide personalized treatment decisions that help predict how a patient will respond to a specific treatment, thus making cancer treatment more targeted, effective, and efficient. 

The future of cancer treatment is “personal”. With precision medicine, we’re entering an era where treatments are smarter, more effective, and designed just for you. In this blog, we’ll explore how companion diagnostics are transforming the future of oncology.  

Emergence and Need for Personalized Treatment Methods 

Personalized treatment transcends traditional methods by tailoring treatments to each patient’s unique traits, genetics, and disease profile. With tools like molecular tests and biomarkers, doctors can match patients with treatments that are more likely to work, improving results and lowering costs. 

Personalized cancer treatments include: 

• Targeted Therapy – therapies designed to target and attack specific genetic mutations or proteins that drive cancer growth. For example, ALK inhibitors for lung cancer or HER2targeted drugs for breast cancer. 
• Immunotherapy – therapies that harness the immune system by boosting the body’s immune response to recognize and target cancer cells. For example, monoclonal antibodies and chimeric antigen receptor T-cell (CAR-T) therapy (genetically modifying a patient’s own T-cells). 
• Hormone Therapy – therapies that lower or block hormone levels to slow cancer growth. For example, hormone-sensitive cancers such as breast or prostate cancer. 
• Gene Therapy – therapies that aim to correct or replace faulty genes responsible for cancer development. For example, a treatment using viruses to infect and kill cancer cells called Oncolytic Virus Therapy (T-VEC to treat advanced melanoma) and the experimental gene editing technology that allows precise changes to DNA called clustered regularly interspaced short palindromic repeats (CRISPR) gene editing. 
• Personalized Cancer Vaccines – therapies that aim to match a patient’s tumor profile to customized vaccines that prepare the immune system to recognize and attack cancer cells. For example, mRNA-4157/V940 a vaccine for melanoma, and cevumeran a vaccine for pancreatic cancer.

Key Considerations 

Personalized treatment strategies are revolutionizing healthcare by replacing the one sizef itsall model with a patient-centered approach. Advanced techniques like genetic tumor profiling, pharmacogenetics, and companion diagnostics identify mutations and match patients with targeted treatments, improving outcomes and reducing side effects. Biomarkers help predict disease progression, guide treatment choices, and track immune responses for greater precision. Innovations in genomics, biotechnology, and artificial intelligence (AI), such as mRNA cancer vaccines and molecular pattern recognition tools, are driving this transformation, making healthcare more intelligent, fast, and efficient. 

Companion Diagnostics 

Companion diagnostics are specialized laboratory tests, often in vitro diagnostic devices, that help doctors choose safe and effective treatments for each patient. They are usually developed alongside targeted therapies to identify who may benefit most or who may face higher risks. These tests detect specific biomarkers (such as gene mutations or protein expressions) that predict treatment response. Developing these tests involves discovery, assay design, clinical validation, and regulatory approval, usually through collaboration between diagnostic and pharmaceutical companies. They guide treatment choices, improve outcomes, and avoid ineffective treatments. Some notable examples include the immunohistochemistry test for ceritinib and fluorescence in situ hybridization technique for crizotinib. 

Pharmacogenetics 

Our genes hold the blueprint for creating various proteins and enzymes that control how the body responds to treatment. Pharmacogenetics explores how a person’s genetics influences their treatment response. Genetic variations called single nucleotide polymorphisms can alter how the body responds to medication; and affects its safety and effectiveness. Pharmacogenetic testing helps doctors select the best treatment and dose for each patient, ensuring early diagnosis, improving treatment effectiveness, reducing side effects, and lowering the risk of hospitalization. Well-known examples include enhancing treatments like tamoxifen for breast cancer and irinotecan for colorectal cancer. 

Biomarkers 

A biological marker or simply “biomarker” is a measurable indicator or signal that shows what’s going on in the body like whether you’re healthy, sick, or responding to treatment. They can be found in blood, urine, tissues, and include biomolecules like genes, proteins, or hormones. Doctors use biomarkers to help diagnose diseases, predict how they progress, see if treatments are working, or monitor immunologic response. Scientists develop biomarkers by identifying patterns linked to specific diseases or drug responses. Well-known examples include breast cancer (BRCA) gene mutations for assessing breast, ovarian, prostate, and pancreatic cancer risk; and programmed death-ligand 1 (PD-L1) testing for lung and bladder cancers. As medicine becomes more personalized, biomarkers play a very significant role in customizing treatments for individual patients. 

Key Takeaway 

Traditional treatment methods often overlook an individual’s differences in genetics, environment, and lifestyle, which can affect treatment response. Personalized treatment methods are transforming modern healthcare by tailoring medical care to an individual’s unique biology, enabling early and accurate diagnosis, improving treatment effectiveness and prognoses, and reducing delays. For example, prostate cancer biomarkers found in urine could lead to faster and less invasive diagnosis. Personalized treatment also helps prevent disease through early detection and proactive risk assessment, leading to better outcomes and lower costs by avoiding inconclusive tests, unnecessary treatments, and delays in treatment approvals. 

Despite its benefits, several challenges like high costs, complex genetic data, and privacy concerns limit accessibility, implementation, and confidentiality. Emerging technologies like wearable devices, electronic health records, genomic sequencing, and AI-driven data analysis are expanding the possibilities of modern medicine. 

We’ve had the privilege of working with teams in the rapidly evolving world of personalized oncology across the data life cycle, from trial design through to regulatory submission. Each collaboration is a chance to spark new ideas, shape strategies, and unlock limitless possibilities in this transformative space. 

To explore innovative oncology development strategies, click here to watch our on-demand webinar, Design, Data, and Decisions in Oncology Trials.  

https://mmsholdings.com/webinars/oncology-trial-design-data-decision-making-webinar/