CANCER DIAGNOSTICS: SEARCHING FOR PROFIT

Cancer is increasingly having a major impact on society not only in the United States, but all across the world. It is a disease caused by changes to DNA, when cells divide uncontrollably and proliferate into other tissues within the body. In 2021, almost 2 million people were diagnosed with cancer in the United States alone. Therefore, scientists and researchers have been working for years to find an effective cure for cancer. Even with all of our current technology, there is still no cure. With the increasing interest in cancer research, the cancer diagnostic technology industry is also rapidly growing. In 2018, the global cancer diagnostics market size was valued at USD 144.4 billion and is expected to reach USD 249.6 billion by 2026. Expanding the cancer diagnostic industry would lessen the negative impact that cancer has had on society.

By Tammy Tran, Biotech Analyst  

Companion Diagnostics 

Companion diagnostics are medical devices, oftentimes in vitro, that provide important information essential for the safe and effective use of a drug or biological product. These diagnostics help a healthcare professional determine whether or not the product’s benefits outweigh the potential risks and side effects. Currently Qiagen ($QGEN), a provider of technologies for molecular diagnostics, applied testing, and academic and pharmaceutical research, is partnering with Mirati Therapeutics ($MRTX), a biotechnology company aimed at developing breakthroughs for cancer patients, in order to develop a new companion diagnostic for cancer patients. They are developing a tissue based KRAS companion diagnostic that will be able to identify cancer patients that have the KRAS G12C mutation, a frequent indicator of cancer. KRAS is a member of the RAS family, a family of genes that are responsible for cell proliferation, differentiation, and survival. It is also an oncogene, a gene that can transform a healthy cell into a tumor cell, and is found to be the most frequently mutated oncogene in cancer patients. The G12C part of the mutation means that it is a single point mutation with a glycine to cysteine substitution at codon 12. However, the current and previous efforts to develop targeted therapies against this mutation have all been unsuccessful. The diagnostic that Qiagen ($QGEN) and Mirati Therapeutics ($MRTX) is working on is a treatment with adagrasib, a potent oral molecular inhibitor of the KRAS G12C mutation. Adagrasib is currently in the Phase 1/2 clinical trial for patients with non-small cell lung cancer and colorectal cancer. It works by inhibiting KRAS G12C which suppresses the signaling pathway and tumor growth. The inhibition increases the amount of regulation genes that are activated throughout the body. The adagrasib along with the other inhibitors produced due to the hyperactivation work together to combat the mutation and increase anti-tumor activity. The companion diagnostics total addressable market was USD 3.7 billion in 2020, and is projected to reach USD 6.8 billion by 2025. Qiagen’s ($QGEN) total addressable market is over USD 11 billion. Specifically, Qiagen’s ($QGEN) revenue for 2020 was USD 1.87 billion and is currently USD 12.9 million for Mirati Therapeutics ($MRTX). The overall revenue for the oncology companion diagnostic market is forecasted to be US 5.7 billion. 

Liquid Biopsy

Another emerging technology in the field of cancer diagnostics is a liquid biopsy. A liquid biopsy is a blood test extracted from a tumor that either looks for cancer cells circulating in the blood or for pieces of DNA. These biopsies are advantageous because they allow for early cancer stage detection. Liquid biopsies are different from tissue biopsies because they are less invasive, risky, costly and painful. There are two types of materials found in blood that can indicate the presence of cancer in molecular analysis: circulating tumor cells (CTCs) and cell-free circulating tumor DNA (cfDNA or ctDNA). The larger the volume of the tumor, the greater the amount of cfDNA that is released into the bloodstream. As a result, healthcare professionals are able to take blood samples from a patient’s arm to determine whether or not the patient has cancer. The amount of cfDNA released into the bloodstream can range anywhere from 0.01% to 90% of the DNA present in the plasma. Abnormal CTCs or cfDNA can help determine: DNA abnormalities, RNA expression, protein expression, amplification and deletions, translocations, chromosomal abnormalities, and point mutations. Although liquid biopsies are primarily used to diagnose cancer at an early stage for intervention purposes, they can also be used in the other stages as well. For localized diseases, liquid biopsies can determine the risk of recurrence after treatment. For metastatic diseases, or cancers that have spread throughout the body, doctors can use the liquid biopsy to select the best treatment plan based on the biomarkers that are present. For refractory diseases, cancers that have stopped responding to treatment, liquid biopsies can help doctors understand the mechanisms of resistance and how the disease progressed. However, since this technology is still in its early stages, there are a few concerns that need to be addressed. The test results can often show false-positives, meaning that these biopsies detect cancerous DNA when the patient is actually healthy. In addition, these biopsies can detect tumors that are actually harmless or will not grow. This could result in over treatment, which could be harmful and expensive for the patient. Many large companies are still working to develop this technology such as: Paragon Genomics, Grail, Guardant Health ($GH), Personal Genome Diagnostics, Thermo Fisher Scientific ($TMO), and many more. Guardant Health ($GH), one of the largest liquid biopsy firms, expects the full year 2021 revenue to be in the range of USD 360-370 million, representing almost a 30% growth compared to 2020. The total addressable market for liquid biopsies should grow from USD 3.8 billion in 2020 to USD 19.6 billion by 2025. This area has many opportunities for growth such as advancement in technologies, growing demand in diagnostic centers, and expansion to developing countries.

Artificial Intelligence: Digital Pathology

AI-led digital pathology is another emerging area for cancer diagnostics. Artificial intelligence is advantageous because it can spot subtle patterns that can be easily missed by humans. Quest Diagnostics ($DGX) is partnering with Paige, a digital pathology company, to develop AI focused cancer diagnostics using pathology images. This new technology relies on Paige’s innovative machine learning and algorithms which then extracts useful diagnostic data from the pathology slides and images. To begin with, this collaboration is focusing on solid tumor cancers such as breast, colorectal and lung. The AI will be able to pick up tissue patterns and markers that are difficult for humans to see. For example, patients can get a full-genome methylation analysis, which checks for small hydrocarbon molecules attached to DNA. Extra methyl groups are oftentimes the mechanism behind epigenetics, the study of heritable changes in gene expression. Different methylation patterns also often indicate that cancer is present. Physicians can then feed the results of the methylation analysis to an AI system, and the computer can classify the tumor. Correct classification of the tumor is extremely important since different tumors require different drug and radiation treatment plans. As a leader in advanced diagnostics, Quest’s ($DGX) yearly revenue was USD 7.73 billion in 2019. Paige’s platform is also growing, with an estimated annual revenue of USD 70.9 million per year. The global article intelligence in diagnostics market size in 2019 was USD 288.1 million in 2019, and is expected to grow by over 30% in the years 2020 to 2027.

Cancer diagnostics is an important field that will continually grow within the next few years. Scientists have been trying to combat and find a cure to cancer for decades and have been unsuccessful. Therefore, finding an early diagnosis is crucial to getting proper treatment. The diagnostic technology industry is only just beginning and will only continue to expand from here on out. Therefore, staying up to date with the current emerging technologies is important for everyone since they will have such a large and positive impact on our society.