Dear Consumers, Health and Food Executive Agency,

Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I am requesting documents which contain the following information:

I would like to access information with regard to the molecular pathology testing as it relates to companion diagnostic testing (tests paired with specific drugs) that are offered within the following countries: UK, France, Germany, Spain and Italy. If this information is unavailable from this agency, I would request you direct me to the agency you believe holds such health information.

I would like information regarding the type of companion diagnostic tests are offered for each indication listed bellow, the charge per patient test in each country (ideally a comment on what the overhead/kit breakdown of the test cost is) and the number performed per year January-December (or month if easier – please specify in comments) nationally.

Test Types: IHC = Immunohistochemistry, FISH = Fluorescent In-Situ Hybridization, PCR = Polymerase Chain Reaction, NGS = Next Generation Sequencing. If the lab performs another test type (e.g. pyrosequencing) or the test is linked to another oncological therapy not listed please check “Other” and include it in the comments section.

Indications and Markers:

Breast Cancer - HER2 Testing (Price HER2 Test: €, Number of HER2 tests: )

Colorectal Cancer - KRAS Testing (Price KRAS Test: €, Number of KRAS tests: )

Non-Small Cell Lung Cancer - ALK and EGFR (Price ALK Test: €, Number of ALK tests: ) (Price EGFR Test: €, Number of EGFR tests: )

Melanoma- (Price BRAF Test: €, Number of BRAF tests: )

Yours faithfully,

Jordan Betel