Do New Blood Tests for Cancer Meet the Right Standards?
Biotech startups globally are launching blood tests that they say can detect various types of cancer in the early stages. These tests claim to be a simpler way to detect cancer by eliminating the need for traditional scanning and swabbing by doctors. Dr. Hilary A. Robbins from the World Health Organization in France is intrigued by the potential of these tests. These tests have the potential to detect dozens of types of cancer that currently have no screening methods. However, these tests have not met the strict criteria typically required for traditional cancer screening tests. Typically, a screening test needs to meet four key criteria, but these new blood tests have only met the second criteria. The next step is to show that these tests can impact cancer-specific mortality. There are concerns that commercial interests may be influencing the evidence standards for these tests. Some argue that initial approval should not depend on cancer-specific mortality, as it could take too long to gather sufficient data. Dr. Eric A. Klein and his colleagues suggest alternative endpoints such as the incidence of late-stage cancer.
The concept is that a negative signal does not indicate a mortality benefit, but a positive signal could lead to provisional approval. Klein is associated with a biotech startup called Grail, which has developed a blood test that can detect over 50 types of cancer. This test is already available for consumers in the United States. The UK’s National Health Service launched a study to assess the effectiveness of Grail’s test, using a different primary endpoint. Recruitment for this study was stopped after 140,000 participants were enrolled, but the initial results were not convincing enough to continue. The study deviates from standard design in terms of both the primary endpoint and blinding methods. This design may prevent the exploration of the potential drawbacks of these tests, such as false security. According to Robbins, participants must receive their test results to accurately assess the risk-benefit ratio of these tests. The National Cancer Institute in the United States is planning a large trial to evaluate several new cancer tests for their impact on cancer-specific mortality. Robbins emphasizes the importance of setting a high bar for these tests and ensuring that commercial interests do not influence the design and execution of studies.
Receiving a cancer diagnosis when it’s too late for effective treatment is a heartbreaking reality. Early detection, diagnosis, and prevention are vital in saving lives from cancer. One in nine Indians are likely to develop cancer in their lifetime. Cancer is responsible for 18% of deaths from noncommunicable diseases in India. In 2022, an estimated 14 lakh new cancer cases occurred in India, with a projected increase of 12% by 2025. Breast, cervical, ovarian, and colorectal cancers are the most common among women, while lung, esophageal, colorectal, and stomach cancers are dominant among men in India. Late detection of cancer leads to lower survival rates and expensive treatments, while early detection makes it easier to treat and extend lifespan. Many countries have aligned with the United Nations’ SDGs to ensure early detection of cancer. The National Health Service in England aims to increase the proportion of people diagnosed at an early stage from 50% to 75% by 2028. Organized cancer screening programs, especially for breast, cervical, and colorectal cancers, have shown to reduce mortality. Lung cancer screening is expanding globally, while prostate cancer screening is not widely recommended as a formal program.
Organized cancer screening programs are not common in low- and middle-income countries like India. As per the recent National Family Health Survey, only 0.2-2% of people in India have undergone any form of cancer screening. The success of any cancer screening program depends on high uptake, but barriers like anxiety, embarrassment, and limited access to screening facilities can hinder it. The COVID-19 pandemic has further impacted cancer screenings due to limited access. Blood-based tests offer a promising way to detect multiple types of cancer at a reasonable price. The multi-cancer early detection (MCED) test, a type of liquid biopsy, has shown to detect up to 50 types of cancer, including difficult-to-detect and aggressive ones. The MCED test is different from genetic testing, which looks for inherited genes related to cancer risk. In India, the MCED test is still not approved by the CDSCO and is only available as a laboratory-developed test. Post-testing support, education, and counseling services are crucial for patients and clinicians after a positive MCED test result to manage the emotional and psychological impact.
An article reports that the Galleri blood test, designed to detect multiple types of cancer from a single blood sample, should not be used by the National Health Service (NHS). The report, published in the British Medical Journal (BMJ), suggests that the test’s selection for large-scale trials by the NHS was motivated by politics rather than scientific evidence. The investigation, led by Margaret McCartney and investigative journalist Deborah Cohen, raises concerns about the effectiveness of the Galleri test and whether the criteria for success have been set too low. Experts believe that the ongoing NHS trial of the Galleri test is unethical and there are questions about how this particular test was chosen for evaluation. The deal between the NHS and the developer of the Galleri test, US biotechnology company Grail, is also questioned for being too industry-friendly. The Galleri test claims to be able to detect over 50 types of cancer by analyzing DNA fragments known as cell-free DNA (cfDNA) in the blood. The test uses machine learning and artificial intelligence to analyze specific methylation patterns in the cfDNA to detect the presence of cancer.
NHS England hopes that the Galleri test will replace individual cancer screening tests currently offered and improve early detection rates, ultimately saving lives. The test is considered a major part of the NHS’s goal to diagnose 75% of cancers at early stages by 2028. The ongoing NHS trial, costing £150 million, began screening patients in mid-2022 and has recruited over 140,000 people aged 50-77. However, leaked documents reveal that the criteria used in the trial are inadequate and may not support the implementation of a national screening program. The chair of the UK’s Independent National Screening Committee (NSC) raises serious concerns about the trial and its ability to provide evidence on the test’s benefits, harms, and cost-effectiveness. The deal between the NHS and Grail also raises questions as the NHS plans to purchase one million tests after the first stage of the trial and five million more by 2030 if the test fulfills certain criteria. Grail’s owner, Illumina, has been accused of overstating the effectiveness of the Galleri test, leading to a class-action lawsuit in the US and significant financial losses for investors.
NHS England published interim results of the trial but decided not to proceed with a larger-scale program as the results were deemed insufficient. The NHS intends to wait for final trial results in 2026 before making any further decisions about implementing the Galleri test. The involvement of the NSC, usually responsible for evaluating the cost-effectiveness of NHS screening programs, appears to have been bypassed in this case. The decision to proceed with the Galleri test, despite poor early clinical trial results, has raised questions about the influence of politics in the NHS and its decision-making processes. Emails suggest a close relationship between former UK Prime Minister David Cameron and Illumina, Grail’s parent company at the time, may have played a role in the test’s selection by the NHS. The investigation highlights the potential for decisions made by the NHS regarding private companies to be more influenced by politics than sound scientific evidence, and raises concerns about the direction of the NHS and the need for support to secure its future.
Circulating Tumor DNA (ctDNA) is fragmented DNA released by tumor cells into the bloodstream. ctDNA provides important information about the presence and progression of cancer. Liquid biopsies are promising tools for extracting and analyzing ctDNA from blood samples. Detecting ctDNA can be difficult, particularly in early-stage cancers where its levels are low. In an upcoming webinar, Shervin Tabrizi will discuss his work with priming agents to improve the sensitivity of ctDNA detection. His research has paved the way for earlier identification of small tumors and minimal residual diseases. The webinar will cover a range of topics related to ctDNA detection and its applications in cancer diagnosis and monitoring. Shervin Tabrizi is an expert in the field of ctDNA and has made significant contributions to its detection and analysis. The development of priming agents has led to a breakthrough in ctDNA detection and could greatly aid in early cancer detection. The webinar will provide valuable insights and updates on the latest advancements in ctDNA research.
Early cancer detection is crucial for improving prognosis and increasing chances of successful treatment. Despite its potential, the detection of ctDNA remains a challenge for researchers and clinicians. By discussing his research, Shervin Tabrizi aims to shed light on the complexities of ctDNA detection and its clinical implications. Liquid biopsies offer a less invasive alternative to traditional tissue biopsies for diagnosing and monitoring cancer. ctDNA can also be used to monitor treatment response and identify potential resistance to therapy. With the use of priming agents, ctDNA detection has become more sensitive and accurate. This has opened up new possibilities for early cancer detection and personalized treatment. Shervin Tabrizi’s work has been instrumental in advancing the field of ctDNA research and its practical applications. The webinar will provide a platform for researchers and clinicians to stay updated on the latest developments and collaborate on future studies. Further advancements in ctDNA research have the potential to greatly impact the diagnosis and treatment of cancer.
We can now diagnose cancer from a small amount of blood, predicting future occurrences and recurrence. Biopsies were previously the only way to diagnose cancer, but now genetic characteristics can be identified from blood. This is possible due to advances in cancer genetic diagnosis technology through liquid biopsy. Liquid biopsy analyzes nucleic acid fragments in blood, saliva, and urine to track diseases, including cancer. Cancer cells release circulating tumor DNA during proliferation. IMBDX uses technology to identify mutations in circulating tumor DNA using next-generation sequencing. The company was listed on the Kosdaq market in April 2021 with a high competition rate. Professor Kim Tae-you talks about founding the company and its growth in an interview with the Korea Biomedical Review. The company was founded in 2014 when Seoul National University Hospital was designated as a research center for cancer genome analysis.
The Precision Medicine Center at Seoul National University Hospital allowed for research to be applied in clinical practice. Dr. Kim participated in the American Association for Cancer Research where he learned about liquid biopsy technology. They began using next-generation sequencing with blood instead of tissue. The purpose of the research center is to use results for a business model, so the company was started in 2018. Until then, only products from American companies were available in Korea, at a high cost. Dr. Kim wanted to make the test more accessible and developed his own products. The earlier cancer is diagnosed, the better the treatment, and the company offers a precision medicine platform targeting all stages of cancer. Alphaliquid is a product that can simultaneously test 118 cancer-related genes using a single blood sample for targeted therapy. Cancerdetect and Cancerfind are other products for early detection and screening, respectively. These products are covered by health insurance and have been validated through clinical trials. The company’s target markets include the US, Taiwan, Thailand, and Vietnam, as well as offering companion diagnostic services for targeted therapies.