ASCP Explores Innovative Cancer Biomarker Testing Navigator Role
By - April 11, 2024
In the era of precision medicine, testing for the presence of cancer biomarkers is a vital step in identifying which patients may benefit from receiving targeted therapies and immune checkpoint inhibitors.1 In the context of cancer diagnosis and treatment, predictive biomarkers help determine how a patient will respond to specific treatments while prognostic biomarkers provide information about risk for cancer recurrence or progression. Some of the most used methods for identifying biomarkers are immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), and multigene panels using next-generation sequencing (NGS).2 These testing methods identify specific genetic alterations, proteins, or other molecules that allow oncologists to personalize treatment plans, assess prognosis, and monitor patients for treatment responses.
Evolving role of biomarker testing in cancer
Over the past decade, more cancer patients are receiving multiple biomarker tests simultaneously to guide treatment decisions.3 One key driver for this increased testing is the explosion of gene-specific targeted therapies and immunotherapy.
Some common examples of patient care management driven by biomarker testing include:
- PD-L1 using IHC to identify patients who may benefit from
immunotherapy. - Multigene NGS panels to identify patients who may harbor
genomic targets that respond to specific gene therapies. - Multigene prognostic molecular assays that help oncologists personalize
treatment plans based on the risk of cancer recurrence. - Molecular assays to assess for minimal residual disease
(MRD) and treatment response in patients with hematologic
malignancies.
The cancer community has also seen several tumor-agnostic therapies approved by the FDA for patients who have cancers with high TMB, MMR deficiency, NTRK gene fusions, or RET gene fusions.4 Biomarker testing is required to identify these patients and provide them with personalized and effective treatment options that are targeted for their specific condition.
In 2022, the American Society of Clinical Oncology (ASCO) published a provisional clinical opinion on somatic genomic testing to address key questions regarding when biomarker testing should be ordered, what types of assays should be performed, and how these results may impact treatment selection.4
Biomarker testing and diagnostic stewardship
Proper collection and triage of pathology samples is crucial for successful biomarker testing. Negative outcomes are associated with less-than-optimal biomarker testing rates and efficiencies, as compared to recommended best practices. Inconsistent and/or incorrect biomarker testing is problematic and can be mitigated with practice and performance improvement initiatives through enhanced collaboration between pathology and clinical care teams. Patient-derived pathology samples are precious resources and handling of tissue, cells, and other samples, is best done by trained laboratory professionals and pathologists. The American Society for Clinical Pathology (ASCP) believes there will be improved patient outcomes if biomarker testing navigation is facilitated by laboratory professionals. As a result, opportunities exist to improve personalized cancer patient care with laboratory professionals assuming the Biomarker Testing Navigator role.
ASCP launches a biomarker navigation feasibility pilot
Given the evolving landscape of cancer biomarker testing, ASCP aimed to examine the feasibility of a new role called the Cancer Biomarker Testing Navigator (BTN). The concept of a BTN is to have dedicated laboratory staff focused on facilitating and coordinating key tasks in the testing process for in-house and/or send-out biomarker testing to ensure optimal and timely results. ASCP launched a project in 2023 to study biomarker triage in the current laboratory landscape and explore best practices laboratories could employ to optimize biomarker triage and testing with a BTN. This study was sponsored by AstraZeneca. In March 2019, AstraZeneca entered into a global development and commercialization collaboration agreement with Daiichi Sankyo for trastuzumab deruxtecan (T-DXd; DS-8201).
Led by Lynnette Pineault MBA, SCT(ASCP), the ASCP project team used a mixed-methods approach that included an online survey and several focus groups with pathologists and laboratory professionals working in diverse settings such as academic medical centers, community hospitals, and private practices. ASCP also worked with two hospital-based cancer centers to explore the feasibility of having dedicated staff functioning as BTNs focused on cancer biomarker testing processes and tasks.
Opportunities identified to optimize cancer biomarker testing
Through this project, ASCP discovered several key areas to optimize cancer biomarker testing processes and identified potential ways a BTN can address these issues.
The table below outlines some of those barriers and potential opportunities where a BTN could improve processes.
| Barriers to Optimal
Biomarker Testing |
Opportunities for a BTN to Improve Processes |
| Incorrect or incomplete test orders. | Review orders and ensure appropriateness of testing and facilitate correct order placement with clinician. |
| In the ASCP survey, 37% of respondents (n=47) experience delays preparing tissue samples for sendout cancer biomarker testing. | Triage samples and streamline processes to ensure optimal workflows. |
| 60% of respondents in the ASCP survey indicated they do not track turnaround time for multigene NGS panels sent for reference laboratory testing. | Track turnaround times for send-out tests and initiate process improvements to mitigate delays. |
| Focus group participants reported they spend significant time coordinating and facilitating sendout tests when multiple reference laboratories are being used since each has its own ordering portal, requisition form, tissue requirements, etc. | Develop standardized protocols and workflows for reference laboratory send out tests. |
| Tumor tissue from small biopsies may have quantity not sufficient (QNS), resulting in test cancellation or incomplete testing. | Facilitate workflows to ensure pathology samples are adequate for testing and coordinate with clinicians if alternate samples/testing may be needed (like liquid biopsy for circulating tumor DNA). |
| Testing delays due to incomplete patient or insurance information or missing prior authorizations. | Ensure required information is present, and coordinate with the testing laboratory and potentially insurers to ensure testing and prior authorization requirements are met. |
Cancer precision medicine and evolving roles in the laboratory
While most laboratories do not have designated staff focused on cancer biomarker testing, this type of role is emerging as an effective way to coordinate and streamline key tasks. Since send-out tests require a significant amount of coordination, some laboratories have dedicated test send-out staff. Such roles have been described with titles such as “send-out test coordinator,” “pathology navigator,” “precision medicine manager” and involve coordinating or overseeing send-out tests to various reference laboratories, retrieving and uploading test results, and communicating with reference laboratories when issues arise.
Pilot sites
Spartanburg Regional Healthcare System in South Carolina
has been on a long journey to optimize their cancer
biomarker testing processes. While some testing is performed
in-house, most of the multigene NGS panels are
sent out to reference laboratories. Spartanburg built on
their prior work and piloted how a BTN could ensure the
right test is ordered by the oncologist, prepares the tissue,
sends out the block, and tracks turnaround times
and results.
UC Davis in California piloted the BTN role by focusing on bone marrow testing and found having a BTN helped them standardize which tests were being ordered for various types of hematologic malignancies. The BTN worked with attendings and fellows to develop standardizing testing protocols and to review test orders at the time of bone marrow biopsy. The BTN prepared the bone marrow aspirate for testing and tracked turnaround times and results.
Both pilot sites agreed that the BTN is crucial to manage
the increase in biomarker testing requests and the complexity
of sending samples to multiple reference laboratories.
Spartanburg has a team of staff that fill a BTN-type
role, overseen by a supervisor. UC Davis found having a
BTN helped identify ways to streamline and standardize
testing processes for in-house and send-out testing.
Precision medicine stewardship outside of the laboratory
Some cancer centers have dedicated nurse navigators focused on cancer biomarker testing. These individuals may meet with patients, discuss how biomarker testing may impact their care, and enter or review orders to ensure the right tests are being performed. Some of these nurse navigators may review test results and prepare case presentations for molecular tumor boards. Cancer centers have formed precision medicine committees or biomarker testing task forces to oversee how testing is performed, to evaluate and select reference laboratories for send-out tests, and to develop standardized reflex testing protocols. The Association of Community Cancer Centers (ACCC) showcases several examples of precision medicine stewards who coordinate and optimize biomarker testing processes.5
Navigating patient samples
Like nurse navigators whose role is to ensure patients receive proper healthcare and resources for their condition, navigators are also needed in the laboratory to ensure patients’ tissue and cell specimens are collected and tested in a timely and appropriate manner. A BTN could address all six key domains of healthcare quality outlined by the National Academy of Medicine (NAM), formerly known as the Institute of Medicine (IOM):6
- Safe
- Effective
- Patient-centered
- Timely
- Efficient
- Equitable
A BTN could ensure cancer patients receive effective and timely biomarker testing in many ways. This role could serve as a liaison between the laboratory and ordering clinicians, providing collection and testing guidance. A BTN could help with benchmarking and quality measurement initiatives to identify and eliminate waste and/or defects in current workflows, such as incorrect orders or insurance issues, to improve efficiencies in the testing process. There may also be a role for BTNs to provide patient support with shared workflows, for example identifying patients with paired somatic-germline testing and coordinating genetic counseling, ensuring patient-centered and equitable care.
Conclusion
As ongoing research advances new cancer treatment options, successful translation of this evidence into clinical practice relies on sound operational workflows, ensuring patients receive recommended testing and treatment. Biomarker testing is an important step for identifying patients who may benefit from targeted therapies or immunotherapy, leading to improved outcomes. The BTN role in the laboratory is a novel solution for ensuring the proper collection and triage of pathology samples for biomarker testing. ASCP looks forward to publishing the complete findings from this project in upcoming manuscripts.
References
- Dietel M. Molecular Pathology: A Requirement for Precision Medicine in Cancer. Oncol Res Treat. 2016;39(12):804-810. doi: 10.1159/000453085. Epub 2016 Nov 25. PMID: 27889782.
- Hess LM, Krein PM, Haldane D, Han Y, Sireci AN. Biomarker Testing for Patients With Advanced/ Metastatic Nonsquamous NSCLC in the United States of America, 2015 to 2021. JTO Clin Res Rep. 2022 May 7;3(6):100336. doi: 10.1016/j.jtocrr.2022.100336. PMID: 35677681; PMCID: PMC9168140.
- Yan JT, Jin Y, Lo E, Chen Y, Hanlon Newell AE, Kong Y, Inge LJ. Real-World Biomarker Test Utilization and Subsequent Treatment in Patients with Early-Stage Non-small Cell Lung Cancer in the United States, 2011-2021. Oncol Ther. 2023 Sep;11(3):343-360. doi: 10.1007/s40487-023-00234-7. Epub 2023 Jun 18. PMID: 37330972; PMCID: PMC10447355.
- Chakravarty D, Johnson A, Sklar J, Lindeman NI, Moore K, Ganesan S, Lovly CM, Perlmutter J, Gray SW, Hwang J, Lieu C, André F, Azad N, Borad M, Tafe L, Messersmith H, Robson M, Meric-Bernstam F. Somatic Genomic Testing in Patients With Metastatic or Advanced Cancer: ASCO Provisional Clinical Opinion. J Clin Oncol. 2022 Apr 10;40(11):1231-1258. doi: 10.1200/ JCO.21.02767.
- Association of Community Cancer Centers. Precision Medicine Stewardship. accc-cancer.org/home/learn/ precision-medicine/care-coordination/precisionmedicine- stewardship
- Institute of Medicine (IOM). Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, D.C: National Academy Press; 2001.
The authors would like to thank the ASCP Biomarker Testing Navigator Initiative Contributors for their input to this article: Joseph Kim, MD; Suzanne Ziemnik, MEd; Melissa Kelly, PhD; James D. Morgante, PhD.
