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Oncology Diagnostics
Research shows that a global cancer surge is underway, with cases doubling since 1990 and reaching 18.5 million new diagnoses in 2023.1 Cancer-related deaths have also climbed to over 10 million a year, with the steepest increases hitting low- and middle-income countries.1
Without urgent action to implement better cancer control policies, researchers project more than 30 million new cancer cases annually by 2050.1 It’s also worth noting that around four in 10 cancer deaths are tied to preventable risks, such as smoking, poor diet and high blood sugar.1
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"Cancer remains an important contributor to disease burden globally … with disproportionate growth in countries with limited resources. Despite the clear need for action, cancer control policies and implementation remain underprioritized in global health, and there is insufficient funding to address this challenge in many settings. - Dr. Lisa Force, Institute for Health Metrics and Evaluation (IHME), University of Washington, USA1 |
- Defining Cancer
- The role of oncology diagnostics in cancer care
- The future of oncology diagnostics
- Frequently asked questions
- How Medix Biochemica makes a difference
Defining cancer
Cancer is a disease that begins with a disruption in the cell replication cycle.2 Changes within a single cell (e.g. damage to the cell’s DNA) can affect its ability to repair itself or self-destruct appropriately. Uncontrolled replication can lead to a build-up of cells, i.e. a tumor. If the tumor is malignant, it may continue to grow, invading other parts of the body or spreading to other organs.2
The role of oncology diagnostics in cancer care
Access to timely, accurate testing, quality treatment and follow-up care is essential for improving cancer patient outcomes.2
Diagnostics, including clinical laboratory testing play a vital role in cancer care:
- Risk evaluation: As some cancers are more likely to develop under certain criteria, evaluation programs can help determine if someone has an elevated risk
- Cancer screening: Testing can identify specific types of cancer early, before signs or symptoms appear
- Disease determination: Biopsy testing can determine the presence of cancer and whether it has spread
- Therapy selection: If cancer is confirmed, additional testing can help doctors decide on the best treatment plan. This may include tests for biomarkers to help personalize treatment
| A biomarker is defined as a biological signal that indicates disease |
- Treatment monitoring: Regular check-ups are important for determining the effectiveness of treatment as well as mitigating complications that may come with therapy
- Follow-up care: Care for cancer patients doesn’t end when active treatment ends. Doctors monitor a patient’s overall health to check for recurrent cancers
The oncology diagnostics field is evolving toward precision medicine: researchers are now able to identify the molecular fingerprints of various cancers and use them to divide cancer’s broad categories into far more precise types and subtypes.3 This ‘precision oncology’, which integrates protein and molecular oncology diagnostics into cancer care, allows doctors to tailor treatments to the unique molecular characteristics of an individual patient’s tumor.3,4
Proteomics (the study of the structure and function of proteins) provides real-time insights into tumor biology, complementing genomic data that may not fully reflect the actual protein-level effects driving cancer progression. This allows for better prediction of therapeutic response and refinement of cancer subtypes, beyond what genomics alone can offer.4
Key technologies driving this integration include mass spectrometry (MS), reverse-phase protein arrays (RPPA), immunoassays and liquid biopsy platforms.4 These tools enable the detection of cancer biomarkers in clinical samples such as tissue biopsies, plasma and urine.4
Proteomics is a powerful tool in advancing personalized cancer therapy.4 Looking further to the future, artificial intelligence-driven proteomic platforms are also emerging as valuable aids for clinicians, offering data interpretation through decision-support systems.4 Classifiers trained on proteomic data can distinguish between patients who are likely to respond to specific treatments and those who are not, improving the personalization of their care.4
Cancer biomarkers explained
Cancer biomarkers (also called oncology biomarkers or tumor biomarkers) are substances that may be produced by cancer cells, or produced by the body in response to cancer.5,6
Different types of cancer biomarkers provide distinct insights into the nature and progression of cancer.6
- Protein biomarkers are proteins that serve as biological indicators of a specific condition.6 They provide insights into protein interactions and modifications6
- Genetic biomarkers are specific alterations in an individual’s genome that can be used to indicate the presence of a disease like cancer.6 They can guide the selection of targeted therapy based on an individual's unique genetic profile, and can also be useful in predicting prognosis and assessing recurrence risks6
- Epigenetic alterations are promising biomarkers for cancer due to their stability, their specificity to certain genes and their potential for non-invasive detection6
- Metabolic biomarkers reflect changes in the metabolic pathways of the cell, providing insights into cancer growth and survival, and helping with diagnosis, prognosis and treatment6
- Cellular biomarkers are biological molecules produced by the body or tumor that can be used to detect, diagnose and treat cancer6
Minimal residual disease (MRD) biomarkers are the small amount of cancer cells that remain present after treatment. MRD detection can be used to predict future relapses6
There are also some emerging cancer biomarkers that offer promising new avenues for early detection and personalized treatment.6 These include:6
- liquid biopsy-based biomarkers
- immune-related biomarkers
- multi-omics biomarkers
- biomarkers detected using artificial intelligence
Clinical roles of biomarkers in oncology6
| Role | What biomarkers do |
| Assessing disease risk |
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| Screening for malignancies |
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| Differentiating cancer types |
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| Determining prognosis and recurrence risk |
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| Monitoring treatment response |
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| Predicting treatment response |
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| Guiding therapeutic decisions |
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| Evaluating MRD |
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| Identifying therapeutic resistance |
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| Drug development and research |
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Immunoassays in diagnostic oncology
Immunoassays are foundational technologies for detecting cancer biomarkers.7 They use antibodies to identify and measure specific proteins associated with cancer.7 Common formats include enzyme-linked immunosorbent assays (ELISA), fluoroimmunoassays, chemiluminescent assays and electrochemiluminescent immunoassays.7
Despite the rise of genomic and proteomic tools, immunoassays remain essential. Rather than being replaced by genetic tests, immunoassays complement molecular diagnostics in valuable ways.
Common oncology biomarkers used in immunoassays8
Common examples of oncology biomarkers include the following:
| Biomarker | Cancer type(s) | How the marker is used |
| Alpha-fetoprotein (AFP) |
Ovarian
|
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| CA-125 |
Ovarian
|
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| CA 15-3/CA 27.29 |
Breast
|
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| CA 27.29 |
Breast
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| Circulating tumor cells of epithelial origin (CELLSEARCH) |
Prostate
Breast
|
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| C-kit/CD117 |
Gastrointestinal
|
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| Chromogranin A (CgA) |
Neuroendocrine
|
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| Cytokeratin fragment 21-1 |
Lung
|
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| EGFR |
Lung
|
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| Estrogen receptor (ER) / Progesterone receptor (PR) |
Breast
|
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| HE4 |
Ovarian
|
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| HER2/neu (ERBB2) gene amplification/mutations/protein overexpression |
Ovarian
Lung
Gastrointestinal
Breast
|
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| Neuron-specific enolase (NSE) |
Lung
|
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| Programmed death ligand 1 (PD-L1) |
Lung
Gastrointestinal
Cervical
Breast
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| Prostate-specific antigen (PSA) |
Prostate
|
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| Prostatic acid phosphatase (PAP) |
Prostate
|
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| Somatostatin receptor |
Neuroendocrine
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| Urokinase plasminogen activator (uPA) and plasminogen activator inhibitor (PAI-1) |
Breast
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Rare and emerging cancer biomarkers
Diagnosing rare cancers presents unique challenges, often requiring highly sensitive protein detection methods. Newer techniques like genome sequencing, RNA sequencing and omics analysis are being employed to identify rare cancer biomarkers.9
Adapted from Christyani, Department of Integrated Biomedical Science, Soonchunhyang
Institute of Medi-Bio Science (SIMS), Soonchunhyang University, Cheonan 31151,
Chungcheongnam-do, Republic of Korea, 20249
Viruses and cancer diagnostics
Certain viruses, including human papillomavirus (HPV), Epstein–Barr virus (EBV) hepatitis B (HBV) and hepatitis C (HCV), are linked to cancer and are therefore known as oncogenic viruses.10 Diagnostics are used for infection detection in these diseases, assessing cancer risk, and ongoing monitoring for those affected.
Both immunoassays and molecular testing approaches contribute to viral oncology, each offering complementary advantages.11-13
Read more:
Cancer-Causing Viruses: How Immunoassays Drive Better Diagnostics
The future of oncology diagnostics
At-home and point-of-care (PoC) oncology testing
The future of oncology testing includes models for self-testing and self-collection, making testing more accessible to patients. PoC diagnostic options, like Labman’s next-gen HPV screening device,14 demonstrate how immunoassay formats support decentralized testing.
AI and digital tools in tumor marker interpretation
Interpreting tumor marker data is complex, requiring both trend analysis and evaluation of individual values. Artificial intelligence enhances diagnostic consistency, speed and accuracy, and is being increasingly integrated into laboratory workflows for improved patient outcomes.16
Read more:
From Data to Diagnosis: How AI in Pathology Supports Better Outcomes
Frequently Asked Questions (FAQ)
- How does artificial intelligence improve the sensitivity and specificity of oncology biomarkers?
Artificial intelligence models help uncover complex, non-intuitive patterns in huge multidimensional datasets that traditional methods often miss.17 - What is the difference between protein-based IVD immunoassays and molecular diagnostics in cancer care
The primary difference between IVD and molecular testing is as follows:
- Immunoassays primarily detect proteins or antigens, using antibody-based methods such as ELISA, immunohistochemistry (IHC) and chemiluminescence.7 They provide a fast, simple and cost-effective method of detection, with good sensitivity and specificity18
- Molecular diagnostics focus on detecting nucleic acids (DNA/RNA), testing for gene mutations (e.g. EGFR, KRAS), gene fusions or DNA methylation patterns. They use techniques like polymerase chain reaction (PCR) testing, next-generation sequencing (NGS) and gene expression profiling18
These are rapidly evolving and often appear unpredictably in the market. - How are liquid biopsies being used in multi-cancer early detection (MCED) in 2026?
Liquid biopsies are being used in MCED to analyze blood samples for circulating tumor DNA (ctDNA) and other biomarkers released by cancer cells.19 These tests detect molecular signals such as abnormal DNA methylation patterns, fragmentation profiles (fragmentome), mutations and protein markers associated with cancer.19 - What role do companion diagnostics (CDx) play in selecting biomarker-driven therapies?
CDx is critical in selecting biomarker-driven therapies. It identifies the patients most likely to benefit from a specific treatment, based on their individual molecular profiles.20 CDx can also identify patients with an increased risk of serious side effects, and monitor treatment responses for the purpose of adjusting dosage or regimens to improve treatment safety and effectiveness.20 - What are the most reliable biomarkers for monitoring cancer recurrence?
Circulating tumor DNA (ctDNA) is emerging as one of the most reliable biomarkers for monitoring cancer recurrence.21 Compared to traditional markers, ctDNA offers higher specificity and sensitivity for detecting early disease relapse.21 - Which viruses are most commonly linked to oncogenesis and how are they detected?
HPV, EPV, hepatitis B and C and human T-cell lymphotropic virus type 1 (HTLV-1) are all examples of common oncoviruses.10 These viruses can be detected using immunoassays. - What are the advantages of PoC testing in decentralized oncology screening?
PoC testing enables rapid results at or near the patient’s location, eliminating the delays associated with sample transport and centralized lab processing. This speeds up diagnosis, supports timely treatment and improves outcomes, which is especially critical in fast-progressing cancers.23 - How does digital pathology integrate with tumor marker data for more accurate prognosis?
Digital pathology combines high-resolution histological images with molecular, clinical and radiological information to create comprehensive, multimodal prognostic models.24 - What raw materials are essential for high-quality oncology immunoassay development?
High-quality antibodies and antigens are the foundational components for high-performing immunoassays, directly influencing assay sensitivity, specificity and reproducibility.12 Monoclonal antibodies (mAbs) in particular are critical for precision.12
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Contact our expert team or download our tumor markers catalog to find out more.
