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What’s Holding Back Biomarker Innovation, & How Can We Solve It?

Donald Thomas, MD, FACP, FACR, RhMSUS, & Jason Liebowitz, MD  |  Issue: October 2023  |  October 11, 2023

Unless we unite to fix this system, superior biomarkers from translational research will not get through the complicated process of getting into the much-needed hands of clinicians. Many will get stuck on the bench and never reach the bedside.


Donald Thomas, MD, FACP, FACR, RhMSUS, is a rheumatologist who specializes in caring for patients with lupus and Sjögren’s disease at Arthritis and Pain Associates of P.G. County, Greenbelt, Md. He is the author of The Lupus Encyclopedia: A Comprehensive Guide for Patients and Health Care Providers. He also enjoys teaching at the Walter Reed National Military Medical Center as a clinical associate professor of medicine at the Uniformed Services University, Bethesda, Md.

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Jason Liebowitz, MDJason Liebowitz, MD, is an assistant professor of medicine in the Division of Rheumatology at Columbia University Vagelos College of Physicians and Surgeons, New York.

Disclosures

Dr. Thomas has spoken for Exagen Diagnostics Inc. and is a scientific advisor for Progentec Diagnostics.

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References

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  2. Kernder A, Richter JG, Fischer-Betz R et al. Delayed diagnosis adversely affects outcome in systemic lupus erythematosus: Cross sectional analysis of the LuLa cohort. Lupus. 2021 Mar;30(3):431–438.
  3. Al Sawah S, Daly RP, Foster S, et al. Understanding delay in diagnosis, access to care and satisfaction with care in lupus: Findings from a cross-sectional online survey in the United States [SAT0423, poster presentation]. Ann Rheum Dis. 2015 Jun;74(Suppl 2):812.3–812.
  4. Howard P. People with lupus are waiting more than 6 years for a diagnosis in the UK [press release]. Lupus UK. 2018 Feb 28. https://www.lupusuk.org.uk/six-year-diagnosis-delay.
  5. McClamb D, Oberholtzer L, Marion A, et al. Factors in lupus diagnosis [abstract]. Lupus Sci Med. 2021;8(Suppl 2):A57–A58.
  6. Narain S, Richards HB, Satoh M, et al. Diagnostic accuracy for lupus and other systemic autoimmune diseases in the community setting. Arch Intern Med. 2004 Dec;164(22):2435–2441.
  7. Merrill JT, Petri MA, Buyon J et al. Erythrocyte-bound C4d in combination with complement and autoantibody status for the monitoring of SLE. Lupus Sci Med. 2018 May 23;5(1):e000263.
  8. Putterman C, Pisetsky DS, Petri M, et al. The SLE-key test serological signature: New insights into the course of lupus. Rheumatology (Oxford). 2018 Sep; 57(9):1632–1640.
  9. Mahler M, Andrade LE, Casiano CA, et al. Anti-DFS70 antibodies: An update on our current understanding and their clinical usefulness. Expert Rev Clin Immunol. 2019 Mar;15(3):241–250.
  10. CLFS Files: 23CLABQ3, 2023 Clinical Diagnostic Laboratory Fee Schedule. HCPCS code 83516 in file CLAB2023Q3.cvs. Centers for Medicare & Medicaid Services. 2023 Jul. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Clinical-Laboratory-Fee-Schedule-Files.
  11. Thomas DE, Costedoat-Chalumeau N, Petri M, et al. HCQ in lupus: Should hydroxychloroquine level testing be standard care in lupus? The Rheumatologist. 2020 Feb;14(2):19.
  12. Petri M, Elkhalifa M, Li J, et al. Hydroxychloroquine blood levels predict hydroxychloroquine retinopathy. Arthritis Rheumatol. 2020 Mar;72(3):448–453.
  13. Manzi S, Navratil JS, Ruffing MJ, et al. Measurement of erythrocyte C4d and complement receptor 1 in systemic lupus erythematosus. Arthritis Rheum. 2004 Nov;50(11):3596–3604.
  14. Sun F, Bruening W, Erinoff E, et al. Addressing challenges in genetic test evaluation: Evaluation frameworks and assessment of analytic validity [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US). 2011 Jun. Fryback and Thornbury hierarchical model of efficacy. https://www.ncbi.nlm.nih.gov/books/NBK56754/table/results.t1/.
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  19. O’Malley T, Xie F, Su Y, et al. Complement activation products vs standard ANA testing: Treatment outcomes, diagnosis, and economic impact (CAPSTONE) in systemic lupus erythematosus. J Manag Care Spec Pharm. 2022 Sep;28(9):1021–1032.

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