Question to the Department of Health and Social Care:

To ask Her Majesty's Government which cancers have been recommended by NICE for molecular testing; and of those cancers, for which biomarkers in relation to (1) prognostic tests, and (2) theranostic or treatment predictive tests.

The National Institute for Health and Care Excellence (NICE) recommends molecular testing for the following cancers:

- Acute myeloid leukaemia;

- Bladder;

- Brain;

- Breast;

- Chronic lymphocytic leukaemia;

- Chronic myeloid leukaemia;

- Colorectal;

- Non-small-cell lung cancer;

- Melanoma;

- Oesophago-gastric;

- Ovarian, fallopian tube and peritoneal;

- Pancreatic;

- Prostate;

- Upper aerodigestive tract; and

- Unknown primary origin.

NICE refers to the following companion diagnostic biomarkers in its guidance:

- c-Kit (CD117);

- HER2;

- KRAS;

- EGFR-TK;

- Philadelphia chromosome;

- BRAF V600;

- ALK;

- BRCA;

- p53;

- PD-L1;

- RAS;

- BCR-ABL1;

- FLT3;

- ROS1;

- BRCA1 (germline); and

- Somatostatin receptor-positive.

Tests that are primarily used for diagnosis, monitoring or screening often provide prognostic information. Consequently, there are a large number of biomarkers, many of which are used in standard testing practice and so are not specifically referred to in NICE guidance. Multiple and combinations of biomarkers are often used to provide prognostic information and companies developing tests often create their own combinations.

As many tests look for multiple biomarkers for a single purpose and many tests in standard practice provide prognostic information, NICE is unable to provide categorical information on prognostic tests.