Grail announces long-term results from SYMPLIFY study follow-up

Grail (GRAL) and the University of Oxford announced that long-term results from an extended registry follow-up of the SYMPLIFY study will be presented on Oct. 21 at the Early Detection of Cancer Conference in Portland, Oregon. Patients reported to have a false positive Galleri result were followed for 24 months in national cancer registries for England and Wales. The analysis showed that 35.4% were later diagnosed with cancer within 24 months of enrollment. This reduction in false positives from 79 to 51 resulted in an increase of PPV to 84.2%. In aggregate, 27 of these 28 participants had a correct CSO prediction which could have led to a faster or more efficient diagnosis. In more than half of these cases, the cancer type diagnosed was not congruent with the original diagnostic clinic to which the patient was referred by the general practitioner based on the clinical presentation: 16 of the 28 were diagnosed with cancer within nine months of enrollment. Eight of the 16 were diagnosed with cancers that were correctly predicted by the Galleri test’s CSO finding, but were incongruent with the diagnostic pathway chosen by the general practitioner based on the participants’ presenting symptoms. Overall, 12 of the 28 were diagnosed 10-24 months after enrollment. Seven of the 12 were diagnosed outside the original referral pathway; in those cases, the CSO also was correct, matching the site that was ultimately diagnosed.