FOI Request
- Disclosure ID
- FOI/02269
- Request Date
- March 9, 2018
- Subject
- Biomarker Testing
- Description
- Do you currently offer a biomarker testing for the following, as of the beginning of 2018?
- PD-L1 in NSCLC
- Yes, in house service
- Yes, but send out PD-L1 testing to another laboratory
(Please specify which laboratory samples are sent to: Queen Elizabeth Hospital Birmingham) - No, and do not send to another laboratory
- ALK in NSCLC
- Yes, in house service
- Yes, but send out ALK testing to another laboratory
(Please specify which laboratory samples are sent to: Queen Elizabeth Hospital Birmingham) - No, and do not send to another laboratory
- BRAF in Melanoma
- Yes, in house service
- Yes, but send out BRAF testing to another laboratory
(Please specify which laboratory samples are sent to: Queen Elizabeth Hospital Birmingham) - No, and do not send to another laboratory
- PD-L1 in NSCLC
- Is predictive biomarker testing conducted at the same lab (or similar location such as in same building) as the initial cytological and histological (H&E stain) assessment, or is this done at a different site?
- IHC
- Yes, done at same lab or site
- No, sent to another lab or site
(Please specify which laboratory samples are sent to: Queen Elizabeth Hospital Birmingham)
- FISH /ISH/ NGS / PCR
- Yes, done at same lab or site
- No, sent to another lab or site
(Please specify which laboratory samples are sent to: Queen Elizabeth Hospital Birmingham)
- IHC
- Is biomarker testing performed reflexively or upon request for the following biomarkers?
- PD-L1 in NSCLC
- Reflexively (i.e. prior to starting 1L treatment) providing no previous samples have been tested
- Upon request (i.e. case by case after disease progression)
- If reflexively – What is the laboratory protocol for PD-L1 testing in lung cancer patients – check with QEHB; all NSCLC sent for PD-L1 testing.
- Multi-marker panel (i.e. multiple biomarkers, one test)
- Sequential single gene (i.e. one biomarker, one test)
- Other (Please specify____________)
- ALK for NSCLC
- Reflexively (i.e. prior to starting 1L treatment) providing no previous samples have been tested
- Upon request (i.e. case by case after disease progression)
- If reflexively – What is the laboratory protocol for ALK testing in lung cancer patients – check with QEHB; all NSCLC adenocarcinomas sent for ALK testing
- Multi-marker panel (i.e. multiple biomarkers, one test)
- Sequential single gene (i.e. one biomarker, one test)
- Other (Please specify____________)
- BRAF in Melanoma
- Reflexively (i.e. prior to starting 1L treatment)
- Upon request (i.e. case by case after disease progression)
- If reflexively – What is the laboratory protocol for BRAF testing in melanoma patients
- Multi-marker panel (i.e. multiple biomarkers, one test)
- Sequential single gene (i.e. one biomarker, one test)
- Other (Please specify____________)
- PD-L1 in NSCLC
- Which of the following biomarkers are assessed in lung cancer patients in your laboratory? (please select all that apply)
- ALK
- EGFR
- ROS1
- DLL3
- PDL-1
Highlighted tests are sent to QEHB, none of these currently provided in-house
- Which of the following testing platforms are used at this this laboratory? (please select all that apply)
- FISH
- NGS
- PCR
- IHC
- Other
IHC done in house, others we would send away currently
- What IHC staining platform(s) are used in the laboratory for biomarker testing? (please select all that apply)
- Ventana
- Dako
- Leica
- Other (If possible, please supply the model of the platform_________)
Highlighted but please check with QEHB
- What type of test does the institution prefer to use for biomarker-predictive IHCs?
- IVD CDx (commercial)
- LDT (lab developed)
- None
- What is the main factor in this decision?
- Funding constraints
- Control over methodology
- Other (Please specify____________)
Needs asking from QEHB
- Does your lab / trust seek separate reimbursement from NHS under the “high-cost medicines and tests” provision for biomarker tests that have been excluded from tariff?
- Yes
- No
- What is the number of samples being tested (or sent-out) are tested for the following biomarkers?
- ALK
Please specify number: 15-20 (per month) - EGFR
Please specify number: 15-20 (per month) - PD-L1
Please specify number: 35 (per month) - BRAF
Please specify number: <5 (per month)
- ALK
- Where are archived tissues from lung cancer patients stored?
- On-site
- Off-site
- If on-site; how long are tissues stored on site until transferred to other storage facility?
- Never
- <1 yr
- 1-2 yrs
- >2 yrs
- What is the typical turn-around time from tissue/specimen extraction to the report of biomarker testing results in lung cancer patients?
- <1 week
- 1 – 2 weeks
- >2 weeks
- How are the following biomarker testing funded at your lab?
- Local funding (financed through pathology / lab budget)
- Pharma funded initiative, please specify details
- Individual funding through high cost medicines and procedures provision
- Unsure
- Do you currently offer a biomarker testing for the following, as of the beginning of 2018?
- Response
Answers are highlighted above.