The first documented case of human cancer was 2 700 years ago, but almost 3 000 years later we continue to be plagued by this devastating illness.1 Cancer is now the no. 2 killer in the world and the global medical and scientific community is devoting time, thought and cutting-edge expertise to improving the prevention, diagnosis and treatment of this deadly disease.2 What role does in vitro diagnostic (IVD) testing currently play in the global battle against this disease, and what will its role be in future?
In 2018 cancer was responsible for 9.6 million deaths across the world (one in every six deaths).3 That’s more than AIDS, malaria and tuberculosis combined. It’s second only to heart disease as the leading cause of death, with both incidence and mortality growing each year.2,4 Without significant progress in the field of oncology prevention and treatment, the number of annual cancer deaths could reach 13.2 million by 2030.4
To give some perspective on the enormity of this health burden, consider that a total of 6 881 401 global COVID-19 deaths had been reported by mid-May 2023.5 It certainly is sobering to consider that cancer kills more people in one year than COVID-19 has since the start of the pandemic.
If robust prevention, screening and early-detection measures are in place – and are followed by access to quality-assured diagnostics and prompt and effective treatment and care – a significant number of these deaths can and should be avoided.2
Major advances in technology and immunochemistry have led to the development of accurate and inexpensive IVD tests, including point-of-care (POC) testing and self-testing.2 The growing inclusion of cancer IVD tests in the second WHO Model List of Essential In Vitro Diagnostics for use in clinical laboratories (WHO EDL), illustrates their increasingly important role in cancer prevention, diagnosis, treatment and care.2
IVD tests play a vital role throughout the cancer care pathway and therefore shouldn’t be described in isolation.2,6
IVDs can be vital for the early detection of cancer2
Between 30% and 50% of human cancers are preventable, and several can be screened for using IVD tests.2 Generally, cancers are easier to treat when they’re detected early, resulting in better patient outcomes as well as a likely reduction in the cost of treatment, with substantial savings to health systems.2
Cancer-specific IVD screening tests
IVD tests specifically used for cancer screening make use of diagnostic pathology techniques such as cytology, surgical pathology, flow cytometry and molecular testing.2 Additionally, fluid biomarkers in blood, urine, stool or other bodily fluids can be used to screen for cancer.2 These biomarkers are proteins or other substances that cancer cells make in higher amounts than normal cells do.
Two examples of tests which screen for biomarkers are:
Predicting cancer risk
IVD testing can answer important questions about a patient’s health status, including their risk or predisposition for developing a certain cancer.2
Guiding post-diagnosis clinical decisions
IVD tests also help clinicians to understand the stage of disease so that they can make appropriate treatment decisions following diagnosis.2
Increasingly, genomic markers such as tumor gene mutations, patterns of tumor gene expression and nongenetic changes in tumor DNA are also being used as tumor markers – either as part of the diagnostic pathology or as part of blood or other fluid testing.2
Determining the appropriate therapy
IVD tests are rapidly becoming an integral part of understanding what therapy may be best for a cancer patient.2 Companion diagnostics highlighting the nature and expression of a patient’s tumor, often determined using IVD techniques, assist clinicians to understand the likelihood of a specific patient benefitting from a particular treatment.2
For example:2
Figure 1: Snapshot of IVD tests currently available within the field of oncology
Source: The role of in vitro diagnostics in early detection and treatment of cancer (American Society for Clinical Pathology, et al. 2021)2
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Trends in cancer detection
Investment in cancer detection through IVD testing has grown rapidly in recent months.7
A 2022 GlobalData report confirms that investment towards and growth in minimally invasive and high-performing oncology tests will continue to drive scientific innovation and the IVD market for years to come.7
Source: Cancer detection drives in-vitro diagnostics venture financing deals
(GlobalData. July 21, 2022)7
Trends in precision medicine
Early detection through techniques such as IVD testing is important. However, precision medicine – quantitation, multiplexing and extremely precise identification of markers – has become the new goal in cancer testing.4 Tools once thought only to be useful in a research setting are now being adopted in clinical practice.4 Among the most promising platforms are digital PCR, mass spectrometry, chromosome analysis, tissue microarrays, next-generation sequencing, and cell signaling pathway testing.4 Knowing the precise nature of what has been detected by IVD tests is essential to ensuring a good outcome for the patient.
Medix Biochemica offers a variety of high-quality products that play an important part in IVD oncology test development and manufacturing, including materials used for:6
What sets Medix Biochemica apart in this rapidly growing field?6
Due to our in-house expertise and sophisticated techniques, we can develop specific antibodies, antigens, and DNA polymerases to meet our customers’ unique needs. So, if a product is not yet in our catalog, we’ll work with you to develop the customized, specialized solutions your product requires.
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References: