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UK has launched a study on “blood cancer testing” for 160K people, 50 types of cancer may be detected early.
On September 13, local time, the British National Medical Service (NHS) issued a statement stating that it officially launched “the largest revolutionary blood cancer test clinical trial.” The test may detect more than 50 types of cancers, including head and neck, pancreas, and larynx, which lack standardized early detection methods, before symptoms appear.
NHS CEO Amanda Pritchard pointed out that this technology may completely change the rate of early cancer diagnosis. “If we can increase the detection rate of stage I and stage II from less than 50% now to 75% in 2028. Patients will have more treatment options, and the 5-year survival rate may be increased by 5 to 10 times.”
Picture from HealthLine
The NHS recruits 165,000 people, what is it going to do?
At present, the NHS is recruiting 165,000 volunteers to participate in the aforementioned clinical trials in 8 regions of England and the United Kingdom.
The test is divided into two parts. The first part requires the recruitment of 140,000 participants between the ages of 50 and 77, with different races and life backgrounds. All people must have not been diagnosed with cancer in the past 3 years.
Volunteers will provide blood samples in 3 times at the time of enrollment, 1 year and 2 years after enrollment. Half of the volunteers served as a control group, provided only samples and performed routine analysis. The other half of the volunteers are the “test group”, who will use Galleri, a product for early detection of multiple cancers, for sample analysis. In the meantime, if participants are suspected of having cancer, they will be immediately referred to the NHS hospital.
Galleri was developed by the American company Grail to determine whether circulating cell-free DNA (cfDNA) with specific methylation characteristics is present in the circulating blood. The cfDNA derived from tumor cells present in the circulating blood of tumor patients is called ctDNA. “This method of using biomarkers in circulating body fluids such as blood to analyze tumors is called liquid biopsy.” “Nature” published a paper in 2020, claiming that tumors will appear in body fluids before cells become cancerous but have not yet formed lesions. Biomarkers, including ctDNA, circulating tumor cells (CTC), microRNA, protein, etc.
“About 2013, in a study of pregnant women, we found something unexpected in 10 blood samples. They showed DNA abnormalities. After further investigation, we learned that 1 out of 10 people has been diagnosed with the disease. Other people have no symptoms of cancer. However, follow-up found that the other 9 people have also been reported to be diagnosed.” Galleri R&D staff recalled.
The second part of the NHS trial will include 25,000 people suspected of having cancer and undergo Galleri testing to speed up the diagnosis. “We hope to obtain initial results in 2023. If successful, we plan to expand the scope of the trial to 1 million people in 2024 and 2025,” the NHS stated.
How accurate is the blood drop test for cancer?
The NHS pointed out that most malignant tumors currently lack effective standardized early detection methods. Many people find that it is late, and the 5-year survival rate is only 21%. Compared with surgical biopsy, liquid biopsy using blood as a sample is less traumatic, and can take multiple samples and detect multiple cancers at the same time, and its application potential is huge.
“This description inevitably reminds people of the’bad blood’ incident in the United States in 2014.” The British “Science Media Center” reported.
At that time, Theranos, a blood testing company in Silicon Valley in the United States, declared that more than 200 tests from blood sugar to cancer can be completed with just one or two drops of blood. For a time, the company was valued at over 9 billion U.S. dollars, and the founder Elizabeth Holmes was extremely prosperous. In the end, Theranos was exposed as a leather bag company with both technology and data fraud. In September 2021, this “blood test” fraud case was heard in the United States. If convicted of 12 counts of fraud, 37-year-old Elizabeth Holmes will face up to 20 years in prison.
But unlike “bad blood”, Galleri has a number of real large-scale clinical studies to support it.
In June 2021, the “Oncology Yearbook” released Galleri’s prospective CCGA (Circulating Cell-free Genome Atlas) research results. It shows that the specificity (the negative detection rate among all negative people) is 99.5% by analyzing the signals of more than 50 different types of cancer through liquid biopsy. This shows that only 0.5% of people will be “misdiagnosed and misreported.”
At the same time, the positive predictive value (PPV) of this test is 51.5%. That is, the rate of those who were positive in Galleri’s test and then went to the hospital for examination and finally diagnosed with cancer reached 51.5%. With the development of cancer stages, the sensitivity of this detection has gradually increased. In addition, in as many as 88.7% of cases, it can correctly identify the tissue or location of the cancer.
Galleri has been approved by the US Food and Drug Administration (FDA) as a “Breakthrough Device”. According to the FDA, this decision is based on early data from the interventional clinical trial PATHFINDER, that is, 12 types of cancer can be detected early through the Galleri test, with a specificity of more than 99%.
Although the test has not been fully approved by the US FDA, in June this year, California, Washington, DC, and Oregon have authorized the test to be used in more than 50 hospitals and more than 1,100 clinics. After prescriptions by doctors of designated institutions, it can be used for detection of high-risk, asymptomatic persons over 50 years old, including breast cancer, cervical cancer, lung cancer, colorectal cancer and more than 50 kinds of cancer.
Picture from Bussiness Wire
“blood drop cancer test” products in other countries
From a global perspective, many institutions are delving into “blood drop testing for cancer.”
In 2019, Johns Hopkins University in the United States issued an article in the journal Science, claiming that it has developed a blood biopsy technology that can detect 8 types of cancer at one time, with a median sensitivity of 70% and a specificity. 99%. This technique has the highest sensitivity for ovarian cancer and liver cancer, followed by gastric cancer, pancreatic cancer, esophageal cancer, and colorectal cancer, all with detection sensitivity exceeding 60%.
In June of this year, Toshiba Corporation of Japan announced that it had developed a new technology based on microRNA, “As long as a drop of blood is drawn, it can predict 13 types of cancer, including gastric cancer, breast cancer, and ovarian cancer, within 2 hours, with a high accuracy rate. 99%. The cost of the test is about RMB 1,170. If it is included in medical insurance, the cost of the test will be lower.”
There are also “precision projects” for single cancers. The European project PROLIPSY is studying how liquid biopsy can help early detection of prostate cancer. Researchers will analyze CTC, ctDNA and exosomes in people with high levels of protein prostate-specific antigen in their serum.
As early as 2016, China approved the use of the first CTC test kit. “Xinhua News Agency” reported that this marked the official use of liquid biopsy technology in clinical practice in China. In 2015 and 2016, China also successively released two pancreatic cancer microRNA-assisted diagnostic kits.
Cannot replace standard tissue biopsy temporarily
“It is still unclear to what extent liquid biopsy may eventually replace standard tissue biopsy.” In the spring of 2020, Nature said in its outlook for liquid biopsy that this technology is not yet a standard tool in the arsenal of clinical oncologists. .
On the one hand, the proportion of tumor biomarkers in peripheral blood is small, for example, ctDNA is less than 1% of the total amount of ctDNA in peripheral blood. There may be no tumor signal in a drop of blood, or the signal may be too weak to see. Moreover, the background noise of the sequencing technology is very high, and the tumor signal can easily be completely submerged in the background noise. This may lead to deviations in the results.
To obtain accurate detection results, either increase the sample size or strengthen the capture technology and algorithms. This all means higher inspection costs.
On the other hand, not all tumor cells release mutated DNA into the blood. According to data from Guardant Health, a liquid biopsy company, the detection rate of liver cancer is the highest, about 92%, and the lowest detection rate of glioblastoma is only 57%. This is one of the restrictive injuries of liquid biopsy.
“Nature” pointed out that liquid biopsy may be a reliable option for diagnosing primary tumors or judging metastatic lesions in tissues that are difficult to extract samples. It can also help avoid complications after invasive tissue biopsy, such as bleeding, infection, and pain. Before the tumor burden becomes excessive and incurable, regular liquid biopsies can also be used to monitor the risk of recurrence.
“Science and Technology Daily” wrote an article on “cancer test by dripping blood” and stated that the current clinical screening and detection of cancer still mainly rely on traditional methods. Under normal circumstances, the following types of cancer screening are of great significance. Esophageal, stomach, and bowel cancer screening can be done by gastrointestinal endoscopy; lung cancer can be done with low-dose CT examination; liver cancer can be done with color Doppler ultrasound and alpha-fetoprotein detection; breast cancer can be done by self-examination and mammography; cervical cancer can be passed Pap Test; ovarian cancer can be tested for CA-125; prostate cancer can be tested for PSA.
1.NHS launches world first trial for new cancer test. NHS
2.NHS trials new blood test to detect cancer before symptoms appear. Evening Standard
3. The temptation and deceit behind “a drop of blood to test 13 types of cancer”. The Bureau of Health and Knowledge
4.Grail starts selling multi-cancer liquid biopsy Galleri in the US. Medtechdive
5.Expert reaction to announcement of a new NHS pilot on a blood test for more than 50 cancers. Science Media Centre
6.Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set. Annals of Oncology. doi.org/10.1016/j.annonc.2021.05.806
7.This New Test Can Detect 50 Types of Cancer from a Single Blood Draw. HealthLine
8. Can a drop of blood really test for cancer, or does it “look beautiful”? . Science and Technology Daily
(source:internet, reference only)