Biomarkers are physiological indicators that can be measured and used to assess a person’s health.1 Cancer biomarkers may be used to detect, diagnose, or manage certain types of cancer. These biomarkers include versions of genes known to be associated with cancer, or proteins that are present or elevated in persons with cancer.2
Examples of cancer biomarker testing include:
- testing for anaplastic lymphoma kinase gene rearrangements or epidermal growth factor receptor mutation analysis to determine the treatment and prognosis of non–small cell lung cancer2
- BCR-ABL gene testing to diagnose and monitor the status of chronic myeloid leukemia2
- estrogen receptor and progesterone receptor testing to determine hormone therapy treatments for breast cancer2
- human epidermal growth factor receptor 2 (HER2)/neu testing to determine whether to treat breast, gastric, and esophageal cancers with trastuzumab.2
Information is being sought on the safeguards, accreditation, training, and standards in place for cancer biomarker testing across Canada. There is an interest in developing strategies for quality assessment for biomarker testing, specifically for the following testing methodologies: immunohistochemistry (IHC), in situ hybridization (ISH), fluorescence in situ hybridization (FISH), polymerase chain reaction, and genomic sequencing.
The objective of this Environmental Scan is to identify and summarize information regarding cancer biomarker testing in Canada. The following questions are addressed:
- What are the quality assurance and accreditation requirements for cancer biomarker testing in each Canadian jurisdiction?
- What is the association between the quality of laboratory test results for cancer biomarkers and the laboratory experience and volume of testing?
The findings of this Environmental Scan are based on responses to the Cancer Biomarker Testing in Canada 2015 survey (Appendix 1) and a limited literature search. To identify the quality assurance and accreditation requirements for cancer biomarker testing (Question 1), surveys were sent to key informants from cancer agencies and health care agencies from jurisdictions across Canada. Survey data were gathered until September 23, 2015. To identify the association between the quality of laboratory test results and the experience or volume of the laboratory (Question 2), a limited literature search was conducted on key resources including MEDLINE, Embase, PubMed, and the Cochrane Library. Grey literature was identified using the CADTH Grey Matters checklist.3 Methodological filters were applied to limit retrieval to health technology assessments, systematic reviews, meta-analyses, and guidelines. Where possible, retrieval was limited to the human population. The search was limited to English-language documents published between January 1, 2010 and August 13, 2015. Conference abstracts were excluded from the search results.
Quality assurance measures and accreditation requirements for cancer biomarker testing in Canadian jurisdictions is the focus of this report. Quality assurance measures for laboratory medicine in general, and specific requirements for each accreditation program, were considered out of the scope of this report.
Cancer biomarker testing is important for the detection, diagnosis, or management of certain types of cancer. This Environmental Scan reports current aspects of cancer biomarker testing in Canada. Both a survey and a literature search component were used to assess quality assurance and accreditation for cancer biomarker testing.
Survey responses were received from seven provinces: Alberta, BC, Manitoba, New Brunswick, Nova Scotia, Ontario, and PEI. Many methods for quality assurance for cancer biomarker testing were identified across Canadian jurisdictions and include participation in EQA and IQA, equipment management, standard operating procedures, laboratory accreditation through external accreditation agencies, and best practices–sharing amongst laboratories. All seven responding jurisdictions have specific accreditation requirements for cancer biomarker testing. According to survey responses, laboratories performing cancer biomarker testing in Canada are accredited through the College of American Pathologists4 (Manitoba and PEI), Diagnostic Accreditation Program8 (BC), IQMH12 (Nova Scotia, New Brunswick, and Ontario), Manitoba Quality Assurance Program (Manitoba),11 Accreditation Canada9 (PEI and Nova Scotia), and the College of Physicians & Surgeons of Alberta10 (Alberta). The legal basis for accreditation varies for different jurisdictions.
The experience of laboratory personnel conducting cancer biomarker testing is an important aspect of quality assurance. Continuous education and participation in EQA programs were identified as ways to ensure personnel proficiencies. Guidelines from the Canadian Association of Pathologists exist around the volume of cases needed for laboratories to perform testing; however, these may be based on factors other than technical proficiencies, such as feasibility and cost-effectiveness. Several organizations have outlined requirements for the establishments of reference laboratories, which include personnel competencies and volume of testing performed.