More detailed data on the cancer blood test developed by Grail add to that on tissue of origin testing revealed in the abstract drop last month. Results in a subset of patients from the vast CCGA trial, presented at Asco on Friday, showed that sensitivity of detection of various cancers at a pre-set specificity of 99% varied from 86% in head and neck cancer to 59% in lung cancer – worthy of further investigation, but hardly gobsmacking. Sensitivity varied greatly depending on how advanced the cancer was: 77%, 84% and 92% of stage II, III and IV cancers were picked up, but just 34% of stage I tumours; not great news for a company that is aiming, among other things, to develop a pan-cancer screening test. Meanwhile Grail’s arch-rival Guardant Health is gearing up to go to the regulators. Its Guardant360 liquid biopsy has been on sale in the US as a lab-developed test since 2014, but the company plans to put it on a more formal footing with FDA submission expected in early 2020. If granted, approval could be a selling point in itself, but it would also allow Guardant to seek reimbursement, potentially a major sales driver.
Sensitivity of Grail’s liquid biopsy at detecting stages I-III cancer* | ||
---|---|---|
Cancer type | N | Sensitivity (95% CI) |
Head and neck | 36 | 86% (71-95%) |
Anorectal | 14 | 79% (49-95%) |
Pancreatic | 41 | 78% (62-89%) |
Gastric | 9 | 78% (40-97%) |
Oesophageal | 25 | 76% (55-91%) |
Colorectal | 72 | 74% (62-83%) |
Multiple myeloma | 34 | 71% (53-85%) |
Lymphoma** | 60 | 70% (57-81%) |
Liver | 25 | 68% (46-85%) |
Ovarian | 30 | 67% (47-83%) |
Hormone receptor-negative breast | 67 | 64% (52-76%) |
Lung | 151 | 59% (51-67%) |
*All at 99% specificity. **Excludes leukaemias, which are not staged. Source: company communication. |