MCED Blood Test for Early Cancer Detection

Definition

Multi-Cancer Early Detection (MCED)

Tests collectively known as Multi-Cancer Early Detection assays or M.C.E.D.s (MCEDs) (also called liquid biopsies) are new technologies under development that can detect multiple components of growing cancer, such as circulating tumor cells, tumor DNA, and other analytes, in blood or other body fluids. Cancer screening tests are used to check for cancer or signs of risk for cancer before a person has any symptoms. There are two kinds of benefits from cancer screening tests: earlier detection of cancer when it may be more treatable, leading to improved survival and prevention of cancer in those found to be at risk. MCEDs tests look for circulating tumor cells, tumor DNA, and other substances that might be present in several different types of cancer.

Main Digest

Cancer doctors, care providers, and payers need to prepare for a significant shift in early cancer detection that will affect almost every stage of cancer diagnosis and treatment. New data supporting the accuracy of multi-cancer early detection (MCED) blood testing (1), presented at the ESMO Congress 2022, has significant implications for future cancer care provision, said Fabrice André, ESMO 2022 Scientific Co-Chair.

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"It is a duty of professional societies like ESMO to raise awareness of the fact that within the next five years, we will need more doctors, surgeons, and nurses, together with more diagnostic and treatment infrastructure, to care for the rising number of people who multi-cancer early detection tests will identify," explained André, Director of Research at Gustave Roussy Cancer Centre, Villejuif, France and newly elected future president of the Society for the years 2025-2026.

"We need to involve all stakeholders in deciding new pathways of care. We need to agree on who will be tested and when and where tests will be carried out, and to anticipate the changes that will happen as a result of these tests, for example, in the diagnosis and treatment of people with pancreatic and other cancers that are usually diagnosed at a much later stage."

New MCED tests in development can detect a common cancer signal from over 50 different types of cancer and predict where the signal has come from in the body. The signal arises from small sequences of circulating tumor DNA (ctDNA) in the blood, which have some different methylation patterns from non-tumor DNA.

In the PATHFINDER study reported at the ESMO Congress 2022, an MCED test detected a cancer signal in 1.4% of 6621 people aged 50 years and over who were not known to have cancer, and cancer was confirmed in 38% of those with a positive test. Of 6290 cancer-free people, 99.1% received a negative test result.

Among those with a positive test result, the time to achieve diagnostic resolution (i.e., to find cancer or decide there was no evidence of malignancy requiring further investigation) was a median of 79 days. Among participants with a positive screening test, a diagnostic resolution was achieved within three months for 73%.

"The results are an important first step for early cancer detection tests because they showed a good detection rate for people who had cancer and an excellent specificity rate for those who did not have cancer. In people with a positive test, it took less than two months to confirm the diagnosis if they had cancer, and it took a bit longer if they did not have cancer primarily because physicians opted to perform imaging studies and then repeat them a second-time several months later to investigate the possibility of a cancer diagnosis," explained study senior author Deb Schrag, Memorial Sloan Kettering Cancer Center, New York, USA.

"An important finding was that few participants with a false positive screening test required multiple invasive procedures such as endoscopies and biopsies. This finding should help to alleviate concerns that these tests could cause harm by generating unnecessary procedures in people who are well," added Schrag.

She stressed the importance of continued standard screening for tumors like breast and colorectal cancer. At the same time, MCED tests are being refined and validated for pancreatic, small bowel, and stomach cancers, where there are currently no screening options.

"This study indicates that hope is on the horizon for detecting cancers that are currently unscreenable, but of course, much more work is needed and, with experience and larger samples, these assays will improve. The tests need to be refined, so they are better at distinguishing tumor DNA from all the other blood circulating in the blood," said Schrag. "It is also critical to note that the purpose of cancer screening is not to decrease cancer incidence but rather to decrease cancer mortality. It is premature to reach conclusions about how MCED testing affects mortality which was not measured in the PATHFINDER study and requires lengthy follow-up."

The study reported at the ESMO Congress 2022 is the first prospective investigation to show that an MCED test can detect cancer in patients with undiagnosed cancer, as previous studies used tests only in patients already known to have cancer. Several further studies are now underway, including a major randomized clinical trial enrolling 140,000 asymptomatic people in England to investigate the clinical effectiveness of MCED testing on cancer outcomes (2).

"We need comparative trials across all types of cancer to find out if having an early detection test affects morbidity and mortality. We also need to know how the tests benefit patients and how to discuss the results with them," said André. "We also need to know more about the small proportion of false positive tests -- MCED results that indicate cancer is present, but standard diagnostic procedures do not confirm this. We need some of these answers before we can calculate the cost impact of introducing MCED tests in routine clinical practice," André concluded.

Background:

A validated blood-based multi-cancer early detection (MCED) test uses cfDNA and machine learning to detect a common cancer signal across >50 cancer types and predict cancer signal origin (CSO). PATHFINDER is a prospective study in a screening population that evaluated the clinical feasibility of MCED testing.

Methods:

Participants were aged ≥50 y with or without additional cancer risk factors. Blood samples were collected, cfDNA analyzed, and MCED test results returned (MCED-E, early version). Cancer status was confirmed at one year for all participants. The primary outcome was the extent of diagnostic testing required for resolution after MCED-E detected the cancer signal. Those with cancer signal and confirmed cancer are true positive (TP), and those without confirmed cancer are false positive (FP). The diagnostic evaluation was at the discretion of the treating physician. Key secondary outcomes included test performance and safety. A pre-specified analysis evaluated a refined test version (MCED-Scr) using the participants' banked specimens without results.

Results:

The MCED-E test detected cancer signals in 1.4% (92/6621) of participants with analyzable samples. Cancer was confirmed in 38% (35/92). Specificity was 99.1% (6235/6290). See Table for primary and secondary outcomes. A total of 73% (24/33) of TPs had a diagnostic resolution in <3 months. MCED-Scr performance was similar to MCED-E (Table). Four AEs were reported (0.06%); none were due to confirmatory diagnostic procedures.

Conclusions:

MCED testing was feasible in outpatient practice without significant AEs and with a PPV of approximately 40%. Studies to refine multi-cancer screening techniques are ongoing.

References:

• 1 Abstract 903O 'A prospective study of a multi-cancer early detection blood test' will be presented by Deb Schrag during the proffered paper session "Basic science and translational research" on Sunday, 11 September, 16:30 to 18:00 CEST in Orléans Auditorium. Annals of Oncology, Volume 33 Supplement 7, September 2022
• 2 Swanton C, Neal RD, Johnson PWM, et al. NHS-Galleri Trial Design: Equitable study recruitment tactics for targeted population-level screening with a multi-cancer early detection (MCED) test. J Clin Oncol 2022; 40(16) suppl. https://ascopubs.org/doi/abs/10.1200/JCO.2022.40.16_suppl.TPS6606?af=R

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Attribution/Source(s):

This quality-reviewed article relating to our Treatment of Cancer section was selected for publishing by the editors of Disabled World due to its likely interest to our disability community readers. Though the content may have been edited for style, clarity, or length, the article "MCED Blood Test for Early Cancer Detection" was originally written by European Society for Medical Oncology, and published by Disabled-World.com on 2022-09-11. Should you require further information or clarification, European Society for Medical Oncology can be contacted at esmo.org. Disabled World makes no warranties or representations in connection therewith.

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