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FOI Request

Disclosure ID
FOI/02269
Request Date
March 9, 2018
Subject
Biomarker Testing
Description
  1. Do you currently offer a biomarker testing for the following, as of the beginning of 2018?
    1. PD-L1 in NSCLC
      1. Yes, in house service
      2. Yes, but send out PD-L1 testing to another laboratory
        (Please specify which laboratory samples are sent to: Queen Elizabeth Hospital Birmingham)
      3. No, and do not send to another laboratory
    2. ALK in NSCLC
      1. Yes, in house service
      2. Yes, but send out ALK testing to another laboratory
        (Please specify which laboratory samples are sent to: Queen Elizabeth Hospital Birmingham)
      3. No, and do not send to another laboratory
    3. BRAF in Melanoma
      1. Yes, in house service
      2. Yes, but send out BRAF testing to another laboratory
        (Please specify which laboratory samples are sent to: Queen Elizabeth Hospital Birmingham)
      3. No, and do not send to another laboratory
  2. 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?
    1. IHC
      1. Yes, done at same lab or site
      2. No, sent to another lab or site
        (Please specify which laboratory samples are sent to: Queen Elizabeth Hospital Birmingham)
    2. FISH /ISH/ NGS / PCR
      1. Yes, done at same lab or site
      2. No, sent to another lab or site
        (Please specify which laboratory samples are sent to: Queen Elizabeth Hospital Birmingham)
  3. Is biomarker testing performed reflexively or upon request for the following biomarkers?
    1. PD-L1 in NSCLC
      1. Reflexively (i.e. prior to starting 1L treatment) providing no previous samples have been tested
      2. Upon request (i.e. case by case after disease progression)
      3. 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.
        1. Multi-marker panel (i.e. multiple biomarkers, one test)
        2. Sequential single gene (i.e. one biomarker, one test)
        3. Other (Please specify____________)
    2. ALK for NSCLC 
      1. Reflexively (i.e. prior to starting 1L treatment) providing no previous samples have been tested
      2. Upon request (i.e. case by case after disease progression)
      3. If reflexively – What is the laboratory protocol for ALK testing in lung cancer patients – check with QEHB; all NSCLC adenocarcinomas sent for ALK testing
        1. Multi-marker panel (i.e. multiple biomarkers, one test)
        2. Sequential single gene (i.e. one biomarker, one test)
        3. Other (Please specify____________)
    3. BRAF in Melanoma
      1. Reflexively (i.e. prior to starting 1L treatment)
      2. Upon request (i.e. case by case after disease progression)
      3. If reflexively – What is the laboratory protocol for BRAF testing in melanoma patients
        1.  Multi-marker panel (i.e. multiple biomarkers, one test)
        2. Sequential single gene (i.e. one biomarker, one test)
        3. Other (Please specify____________)
  4. Which of the following biomarkers are assessed in lung cancer patients in your laboratory? (please select all that apply)
    1. ALK
    2. EGFR
    3. ROS1
    4. DLL3
    5. PDL-1
      Highlighted tests are sent to QEHB, none of these currently provided in-house
  5. Which of the following testing platforms are used at this this laboratory? (please select all that apply)
    1. FISH
    2. NGS
    3. PCR
    4. IHC
    5. Other
      IHC done in house, others we would send away currently
  6. What IHC staining platform(s) are used in the laboratory for biomarker testing? (please select all that apply) 
    1. Ventana
    2. Dako
    3. Leica
    4. Other (If possible, please supply the model of the platform_________)
      Highlighted but please check with QEHB
  7. What type of test does the institution prefer to use for biomarker-predictive IHCs?
    1. IVD CDx (commercial)
    2. LDT (lab developed)
    3. None
    4. What is the main factor in this decision?
      1. Funding constraints
      2. Control over methodology
      3. Other (Please specify____________)
        Needs asking from QEHB
  8. 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? 
    1. Yes
    2. No 
  9. What is the number of samples being tested (or sent-out) are tested for the following biomarkers?
    1. ALK
      Please specify number:  15-20 (per month)
    2. EGFR
      Please specify number: 15-20 (per month)
    3. PD-L1
      Please specify number: 35 (per month)
    4. BRAF
      Please specify number: <5 (per month)
  10. Where are archived tissues from lung cancer patients stored?
    1. On-site
    2. Off-site
  11. If on-site; how long are tissues stored on site until transferred to other storage facility?
    1. Never
    2. <1 yr
    3. 1-2 yrs
    4. >2 yrs
  12. What is the typical turn-around time from tissue/specimen extraction to the report of biomarker testing results in lung cancer patients?
    1. <1 week
    2. 1 – 2 weeks
    3. >2 weeks
  13. How are the following biomarker testing funded at your lab?
    1. Local funding (financed through pathology / lab budget)
    2. Pharma funded initiative, please specify details
    3. Individual funding through high cost medicines and procedures provision
    4. Unsure

 

Response

Answers are highlighted above.

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