Grail reports liquid biopsy data as Guardant heads to market

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.

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