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Reply

Reply to Torlakovic, E.; Normanno, N. Comment on “Bisson et al. Novel Approach to Proficiency Testing Highlights Key Practice Variations in Cancer Biomarker Delivery. J. Mol. Pathol. 2024, 5, 1–10”

1
Canadian Pathology Quality Assurance-Assurance Qualité Canadienne en Pathologie (CPQA-AQCP), Richmond, BC V6Y 1K3, Canada
2
Department of Laboratory Medicine, William Osler Health System, Brampton, ON L6R 3J7, Canada
3
Department of Pathology and Laboratory Medicine, Queen Elizabeth II Health Sciences Centre, Halifax, NS B3H 2Y9, Canada
4
Division of Medical Oncology, William Osler Health System, Brampton, ON L6R 3J7, Canada
5
Division of Medical Oncology, BC Cancer, Vancouver Centre, Vancouver, BC V5Z 4E6, Canada
6
Division of Medical Oncology, Queen Elizabeth II Health Sciences Centre, Halifax, NS B3H 2Y9, Canada
7
Department of Pathology and Laboratory Medicine, University of British Colombia, Vancouver, BC V6T 2B5, Canada
*
Author to whom correspondence should be addressed.
Submission received: 23 April 2024 / Accepted: 14 June 2024 / Published: 27 June 2024
We thank Drs. Torlakovic and Normanno for their interest in our new biomarker proficiency testing program and associated publication [1,2]. In their lengthy letter to the editor, these readers make several comments about the administration of proficiency testing [2]. One claim is identified, specifically stating that the strategies reported by Bisson et al. are in fact not novel. An extensive list of references was proffered by the commentators; however, upon review, none of these reports describe a complete end-to-end proficiency test (starting from FFPE material and ending with a prescribed treatment), nor do they specifically discuss an instance where turnaround time (TAT) is measured by a biomarker proficiency testing program [1,2]. Additionally, the prominently referenced 2021 guideline on behalf of IQN Path denotes “It is not the responsibility of the EQA provider to monitor the laboratory TAT” [2,3]. Through an additional literature review, there was one published report identified of an EQA that measured turnaround time [4]. Given that an integrated end-to-end approach, to our knowledge, has not been included in any previous reports on proficiency testing, the term novel—meaning new and not resembling something formerly known or used—is fully appropriate [5].
In Canada, a publicly funded healthcare state, there is an ongoing problem with respect to equitable access to biomarker testing. This inequity is clearly centered around the fact that many patients cannot achieve timely access to high-quality and easily interpreted biomarker reports [6,7]. The purpose of our novel, and now highly regarded, biomarker quality assurance program is clear and singular: to assess the performance of laboratories in delivering the possibility of precision cancer care to their patients.
We thank you for taking the time to comment on our study.

Author Contributions

Writing—original draft preparation, B.S.S.; writing—review and editing, K.R.B., A.B., M.D.C., S.D., J.M.L., S.S., J.R.W., S.Y. and J.G.G. All authors have read and agreed to the published version of the manuscript.

Funding

The published work of which this reply corresponds to was supported by grants from Pfizer Canada, AstraZeneca Global and Amgen Canada.

Conflicts of Interest

There are not perceived to be any conflicts of interest affecting this reply. Individual author financial disclosures: M.D.C. has received honoraria from Amgen, AstraZeneca, Bayer, Merck, Novartis, Pfizer, and Incyte. S.D. has participated in advisory board meetings with Bristol-Myers Squibb, Eisai, Ipsen, Merck, Pfizer, and Taiho and has received honoraria from AstraZeneca, Ipsen, Merck, and Pfizer. J.M.L has participated in consulting for Ipsen, Amgen, SAGA Diagnostics, and Taiho and has received research funding from Foundation Medicine, Amgen, Ipsen, and Personalis. S.S. has participated in advisory boards for Amgen, Bayer, Beigene, Boheringer-Ingelheim, Astellas, AstraZeneca, BMS, Janssen, Knight, Lilly, Merck, MSD, Novartis, Pfizer, Roche, Sanofi, Taiho, and Takeda; has participated in research trials for Amgen, AstraZeneca, BMS, Merck, Novartis, and Sanofi; and is on the board of directors as President for Lung Cancer Canada. S.Y. has participated in advisory boards for Amgen, AstraZeneca, Bayer, Incyte, Pfizer, and Roche. B.S.S. has participated in advisory board meetings or has received honoraria from Amgen, AstraZeneca, Bayer, Biocartis, Boehringer-Ingelheim, Cell Marque, Elevation Oncology, Eli lily, EMD Serono, Incyte, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, ThermoFisher, and Turning Point Therapeutics. The remaining authors declare no conflicts of interest. The funders had no role in the writing of the reply; or in the decision to publish the reply.

References

  1. Bisson, K.R.; Won, J.R.; Beharry, A.; Carter, M.D.; Dudani, S.; Garratt, J.G.; Loree, J.M.; Snow, S.; Yip, S.; Sheffield, B.S. Novel Approach to Proficiency Testing Highlights Key Practice Variations in Cancer Biomarker Delivery. J. Mol. Pathol. 2024, 5, 1–10. [Google Scholar] [CrossRef]
  2. Torlakovic, E.; Normanno, N. Comment on Bisson et al. Novel Approach to Proficiency Testing Highlights Key Practice Variations in Cancer Biomarker Delivery. J. Mol. Pathol. 2024, 5, 1–10. J. Mol. Pathol. 2024, 5, 258–261. [Google Scholar]
  3. Dufraing, K.; Fenizia, F.; Torlakovic, E.; Wolstenholme, N.; Deans, Z.C.; Rouleau, E.; Vyberg, M.; Parry, S.; Schuuring, E.; Dequeker, E.M.C. on behalf of IQNPath ABSL. Biomarker testing in oncology Requirements for organizing external quality assessment programs to improve the performance of laboratory testing: Revision of an expert opinion paper on behalf of IQNPath ABSL. Virchows Arch. 2021, 478, 553–565. [Google Scholar] [CrossRef]
  4. Dequeker, E.M.; Keppens, C.; Egele, C.; Delen, S.; Lamy, A.; Lemoine, A.; Sabourin, J.C.; Andrieu, C.; Ligtenberg, M.; Fetique, D.; et al. Three Rounds of External Quality Assessment in France to Evaluate the Performance of 28 Platforms for Multiparametric Molecular Testing in Metastatic Colorectal and Non-Small Cell Lung Cancer. J. Mol. Diagn. 2016, 2, 205–214. [Google Scholar] [CrossRef] [PubMed]
  5. “Novel”. Merriam-Webster.com. Available online: https://www.merriam-webster.com/dictionary/novel (accessed on 9 March 2024).
  6. Snow, S.; Brezden-Masley, C.; Carter, M.D.; Dhani, N.; Macaulay, C.; Ramjeesingh, R.; Raphael, M.J.; Slovinec D’Angelo, M.; Servidio-Italiano, F. Barriers and Unequal Access to Timely Molecular Testing Results: Addressing the Inequities in Cancer Care Delays across Canada. Curr. Oncol. 2024, 31, 1359–1375. [Google Scholar] [CrossRef]
  7. Fleming, K.E.; Hupel, A.; Mithoowani, H.; Lulic-Kuryllo, T.; Valdes, M. Biomarker Turnaround Times and Impact on Treatment Decisions in Patients with Advanced Non-Small Cell Lung Carcinoma at a Large Canadian Community Hospital with an Affiliated Regional Cancer Centre. Curr. Oncol. 2024, 31, 1515–1528. [Google Scholar] [CrossRef]
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MDPI and ACS Style

Sheffield, B.S.; Bisson, K.R.; Beharry, A.; Carter, M.D.; Dudani, S.; Loree, J.M.; Snow, S.; Won, J.R.; Yip, S.; Garratt, J.G. Reply to Torlakovic, E.; Normanno, N. Comment on “Bisson et al. Novel Approach to Proficiency Testing Highlights Key Practice Variations in Cancer Biomarker Delivery. J. Mol. Pathol. 2024, 5, 1–10”. J. Mol. Pathol. 2024, 5, 262-263. https://doi.org/10.3390/jmp5030018

AMA Style

Sheffield BS, Bisson KR, Beharry A, Carter MD, Dudani S, Loree JM, Snow S, Won JR, Yip S, Garratt JG. Reply to Torlakovic, E.; Normanno, N. Comment on “Bisson et al. Novel Approach to Proficiency Testing Highlights Key Practice Variations in Cancer Biomarker Delivery. J. Mol. Pathol. 2024, 5, 1–10”. Journal of Molecular Pathology. 2024; 5(3):262-263. https://doi.org/10.3390/jmp5030018

Chicago/Turabian Style

Sheffield, Brandon S., Kassandra R. Bisson, Andrea Beharry, Michael D. Carter, Shaan Dudani, Jonathan M. Loree, Stephanie Snow, Jennifer R. Won, Stephen Yip, and John G. Garratt. 2024. "Reply to Torlakovic, E.; Normanno, N. Comment on “Bisson et al. Novel Approach to Proficiency Testing Highlights Key Practice Variations in Cancer Biomarker Delivery. J. Mol. Pathol. 2024, 5, 1–10”" Journal of Molecular Pathology 5, no. 3: 262-263. https://doi.org/10.3390/jmp5030018

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