New NHS-Galleri study results show that the trial did not meet its primary endpoint of a statistically significant reduction in combined Stage III and IV cancer diagnoses. Secondary findings were more encouraging, although they should be interpreted cautiously. For insurers, MCED results remain relevant but should be treated strictly as screening tools, with underwriting and claims decisions continuing to rely on diagnostic confirmation.
In February 2026, GRAIL released initial results from a landmark clinical trial of Galleri, the biotech company’s multi-cancer early detection (MCED) test.
The highly anticipated study, conducted in partnership with England’s National Health Service (NHS), brings wide-ranging implications across clinical medicine and for the life and health insurance industry. This article provides an overview of MCEDs, the Galleri study, and potential impacts on underwriting and claims, including regulatory considerations.
MCED tests are blood‑based screening tests that analyze fragments of cfDNA shed by tumors in order to:
They are not diagnostic for cancer and require appropriate clinical follow-up. Read more here:
The NHS-Galleri trial is evaluating GRAIL’s MCED blood test in over 142,000 adults aged 50–77 in England. Full data from the three-year trial is not yet published, but GRAIL recently issued an update to investors.
While the trial generated valuable data on feasibility, test performance, and patterns of cancer detection, it did not meet its primary endpoint of demonstrating a statistically significant reduction in combined stage III–IV cancer diagnoses at the population level. This outcome represents a setback for plans to support rapid adoption of the test as a national cancer screening program within the NHS.1
Secondary findings were more encouraging, although they should be interpreted cautiously. The trial showed a “favorable trend” in stage III–IV cancers across a prespecified group of 12 high-mortality cancers (including lung, pancreatic, colorectal, and ovarian cancers), with stage IV diagnoses falling by more than 20% in later screening rounds.
The test also increased detection of earlier stage (I–II) cancers in pre-specified high-mortality cancers that are typically found late, suggesting potential long-term clinical value with repeated use; however, this was not the primary endpoint and does not, on its own, establish a reduction in cancer mortality.
Annual screening with Galleri plus standard-of-care screening resulted in a four-fold improvement in the overall cancer detection rate compared to standard-of-care screening alone for breast, colorectal, cervical, and high-risk lung cancer.2
GRAIL and NHS partners plan to extend follow‑up by 6–12 months, and fuller data with longer follow-up is expected later in 2026.
The NHS‑Galleri trial is a large and complex study, and this early summary captures only part of the picture. Researchers continue to analyze findings and review the full dataset. The complete results will be important for determining how MCED tests, like Galleri, might be deployed in the future.
In the near term, the tests will continue to feature in insurance propositions, so it is important to note that:
Many leading institutions, such as the National Cancer Institute (NCI), National Society of Genetic Counselors (NSGC), National Human Genome Research Institute (NHGRI), and National Institutes of Health (NIH) Genetic Testing Registry, define any test that analyzes DNA sequence, RNA expression, DNA methylation, and chromosomal structure as a genetic test.
Despite broad wording in genetic testing laws across countries, the intent is consistent: protect individuals from discrimination based on inherited (germline) risk, not somatic tests that detect existing disease.
Therefore, while MCED tests technically fall under genetic testing by mechanism, they may not fall under restricted genetic testing categories, depending on jurisdiction.4
Access to, and uptake of, MCED tests will vary largely by geographies as well as customer profile. In some markets, the use of MCED technology is mainly theoretical, and underwriters are therefore unlikely to receive results to consider as part of the application for cover.
However, where access is broader and certain customers access tests, MCED results should be considered a screening tool and not a diagnostic test. In the event of a positive MCED result, further diagnostic tests – such as laboratory, CT, MRI, and biopsy – are indicated, and only once the results of these investigations are available can underwriting continue as per current underwriting practice and philosophy.
The definition of a valid cancer claim under CI products requires defined parameters akin to the following example: “A certified physician must make an unequivocal diagnosis of cancer based on a final tissue histopathological report, and the specified severity of the cancer will be reported as the prognostic stage group based on the latest edition of the American Joint Committee on Cancer (AJCC) Staging Manual.”
From this example definition, it follows that a preliminary screening result, such as a positive MCED test, is not considered an unequivocal or final cancer diagnosis. Baseline evidence for a valid claim continues to be a final histology report.
RGA’s standard CI definition for cancer includes additional clarity through an explicit exclusion regarding “liquid biopsies” as follows: ”All cancers only identified from tumor cells, genetic material, or any other biomarkers, any of which may be present in the blood, saliva, urine, or other bodily fluids, including, but not limited to, tests known as ‘liquid biopsies.’”
Most health insurance policies exclude screening tests and therefore do not reimburse the cost of MCED tests, which are currently considered screening tests rather than diagnostic ones.
That said, using the tests may lead to further healthcare costs, such as additional doctor visits, second-opinion consultations, and a suite of investigative procedures and diagnostic tests, as well as additional downstream services on top of the usual healthcare expenses.
Because following up closely on a positive MCED test result to determine disease presence is prudent clinical judgment, reimbursing related downstream costs is therefore medically justified. This can present a substantial cost burden for patients and health insurers.
Although a positive MCED test would generally fall within the scope of disclosure under standard “special investigations” questions on most application forms, claims assessors should exercise appropriate caution and remain alert. Other disclosures that may suggest the presence of an MCED test or underlying cancer-related concerns include reported signs or symptoms, additional medical consultations, and subsequent diagnostic investigations.
Behavioral aspects such as anti-selection and lapse avoidance, while challenging to forecast, will need to be carefully monitored with respect to availability and access to testing.
MCED tests will continue to feature in insurance propositions, such as voluntary wellness programs and employer‑sponsored benefits, and in high‑net‑worth individual risk assessment.
More detailed results from the NHS-Galleri trial are expected to be published at the American Oncology Conference in May.5 GRAIL also plans to extend the NHS trial’s follow-up period by 6–12 months.
RGA will continue to monitor developments and provide updates:
Contact RGA today for the latest on MCEDs and insurance and what new developments could mean for your business.
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