Criticism from international journals
The Galleri test, made by the company Grail in California, is already commercially available in the US. It is sold online directly to anyone who wants it for NOK 12,000 [GBP 888] per test. The company recommends repeating the test each year, although the basis for this recommendation is unclear (7). Like some other MCED tests, it detects circulating cell-free DNA (cfDNA) from tumours in peripheral blood (8). When a cancer signal is detected, the test should be able to say which organ is the most likely origin of the cancer, and thus should be able to facilitate targeted investigation to locate the tumour. Exactly how the tests do this is protected by patents, and publicly available information is limited (8). There is still a lack of clarity about the best follow-up for patients who receive a positive result for the 50 types of cancer covered by the test.
An ongoing trial with the Galleri test from the market leader Grail has received much attention in the international scientific literature and media (9–11). The trial was lauded as a game-changing collaboration between the National Health Service (NHS) in the UK and the manufacturer Grail, and has enrolled more than 140,000 healthy volunteers in England (9). Patients were randomised to either MCED testing or cancer screening with current methods. The trial's primary outcome measure is not cancer mortality, but stage distribution of newly diagnosed cancers as a surrogate outcome measure. The hypothesis is that more tumours in the MCED group will be diagnosed at an earlier stage. The trial is estimated to cost over NOK 2 billion [GBP 150 million], which is being financed by Grail. Provisional results were expected to be available last year, but have not been published yet. Neither the NHS nor the company has clarified the status of the trial. This has drawn criticism in The Lancet and BMJ (10, 11).
It recently became known that the directors of Grail have been accused of manipulating share prices and forcing out critics of the test (11). Donald Berry, a leading US expert on cancer screening, was asked to leave Grail's expert panel and told the journal Cancer Letter: 'It was like a cult, with sceptics banned. They arranged to talk to and to listen to people who had drunk the Kool-Aid.' (12) The Norwegian oil fund is a part owner of Grail, but has not made a statement about the matter (13).