Lupus
Proactively manage autoimmune disorder with advanced immunologic insights
For patients affected by systemic lupus erythematosus (SLE), managing disease activity is integral to preventing organ damage and other adverse outcomes.
Mayo Clinic Laboratories’ portfolio of novel lupus testing, offered in collaboration with Progentec Diagnostics, objectively assesses multiple pro-inflammatory soluble immune mediators in the blood to characterize and screen for possible increased clinical disease activity and ascertain the future risk of a clinical disease flare. Arming clinicians with this information has the potential to enhance disease management, prevent organ damage, and improve patient outcomes.
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New research guides testing approach
Attaining an accurate measurement of a patient’s immune activity level, which corresponds to current disease severity and future flare potential, can allow for proactive SLE disease management rather than a reactive approach necessitated by the use of validated yet time-consuming clinical disease activity measures.
New research suggests that underlying immune pathway dysregulation, measured in plasma cytokines and chemokines, is the most accurate indicator of SLE disease activity and risk of flare. Measuring these protein biomarkers through laboratory testing can reveal disease characteristics resulting from immune dysregulation that can inform and guide clinical disease management.
Use of objective and sensitive biomarker measurements to gauge clinical disease activity and risk of flare has the potential to prevent organ damage and improve patient outcomes through proactive clinical disease management and pre-emptive treatment.
Characterize disease activity
The Progentec aiSLE® DX Lupus Disease Activity Index assay characterizes patients with active clinical and/or serologic disease versus patients with low or quiescent disease. The well-defined set of 10 biomarkers measured in this assay encompasses the breadth of immune dysregulation associated with SLE and reflects the immune status of individual patients. Results from this test can be used to help determine the necessary frequency of clinical assessments, guide clinical disease management, and evaluate early response to treatment.
Key testing
Advantages
- Algorithm provides a composite index score that differentiates current disease activity into low, moderate, and active states.
- Achieves up to 95% specificity and 100% sensitivity for low, medium, and high risk index thresholds for active disease determined by decision curve analysis. Can be used to assess need for more frequent clinical evaluations in SLE patients with medium to high DAI scores.
- Supports clinical evaluation in patients with heightened disease activity.
- Assists with treatment management by clarifying medication compliance, monitoring dial-down therapies, and enabling steroid-sparing interventions.
Highlights
The following cases are designed for healthcare professionals interested in understanding the assessment and treatment options for patients with systemic lupus erythematosus disease.
The Lupus Foundation of America estimates that at least five million people worldwide have a form of lupus. Yet, the most widely used laboratory tests for patients with this complex condition were developed more than 60 years ago, and physicians need modern, evidence-based tools to provide high-quality care for their patients. That is why Mayo Clinic Laboratories and Progentec Diagnostics joined forces to provide solutions that transform that experience.
In this episode of “Answers From the Lab,” William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories, is joined by special guest Donald Thomas, M.D., a rheumatologist and lupus researcher. They discuss how Mayo Clinic Laboratories’ suite of innovative lupus testing, offered in collaboration with Progentec Diagnostics, is enhancing the care and quality of life for patients affected by systemic lupus erythematosus (SLE).
In this episode of “Answers From the Lab,” William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories, is joined by special guests Bernard Rubin, D.O., MPH, chief medical officer of Progentec Diagnostics, and Melissa Munroe, M.D., Ph.D., chief scientific officer and principal investigator of Progentec Diagnostics. They discuss Mayo Clinic Laboratories’ suite of innovative lupus testing, offered in collaboration with Progentec Diagnostics, for patients affected by systemic lupus erythematosus (SLE).
As a successful outcome of the collaboration announced in 2023, Progentec’s proprietary biomarker blood tests for the proactive management of systemic lupus erythematosus are now available through Mayo Clinic Laboratories.
Mayo Clinic Laboratories, a leading global reference laboratory, and Progentec Diagnostics, a digital health and biomarker technology-based company focused on autoimmune conditions, today announced a strategic collaboration to bring Progentec’s suite of proprietary biomarker blood tests for the proactive management of autoimmune diseases to market. The collaboration aims to increase accessibility for providers and patients across the U.S. and select global markets.
Predict disease flares
The Progentec aiSLE® DX Lupus Flare Risk Index quantifies pro-inflammatory and regulatory immune soluble mediators to calculate a flare risk index, which assigns an individuals score associated with a patient's risk of a forthcoming flare. The index score reported for the test predicts the risk of clinical disease flare over the next 12 weeks.
Key testing
Advantages
- Predicts mild, moderate, severe, or no flare prior to flare occurrence.
- Uses a scientist-developed, weighted algorithm to calculate a flare risk index, which assigns an individual score associated with a patient’s risk of a forthcoming flare.
- Achieves up to 97% sensitivity and 98% specificity for low, medium, and high flare risk index thresholds determined by decision curve analysis.
Highlights
The following cases are designed for healthcare professionals interested in understanding the assessment and treatment options for patients with systemic lupus erythematosus disease.
The Lupus Foundation of America estimates that at least five million people worldwide have a form of lupus. Yet, the most widely used laboratory tests for patients with this complex condition were developed more than 60 years ago, and physicians need modern, evidence-based tools to provide high-quality care for their patients. That is why Mayo Clinic Laboratories and Progentec Diagnostics joined forces to provide solutions that transform that experience.
In this episode of “Answers From the Lab,” William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories, is joined by special guest Donald Thomas, M.D., a rheumatologist and lupus researcher. They discuss how Mayo Clinic Laboratories’ suite of innovative lupus testing, offered in collaboration with Progentec Diagnostics, is enhancing the care and quality of life for patients affected by systemic lupus erythematosus (SLE).
In this episode of “Answers From the Lab,” William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories, is joined by special guests Bernard Rubin, D.O., MPH, chief medical officer of Progentec Diagnostics, and Melissa Munroe, M.D., Ph.D., chief scientific officer and principal investigator of Progentec Diagnostics. They discuss Mayo Clinic Laboratories’ suite of innovative lupus testing, offered in collaboration with Progentec Diagnostics, for patients affected by systemic lupus erythematosus (SLE).
As a successful outcome of the collaboration announced in 2023, Progentec’s proprietary biomarker blood tests for the proactive management of systemic lupus erythematosus are now available through Mayo Clinic Laboratories.
Mayo Clinic Laboratories, a leading global reference laboratory, and Progentec Diagnostics, a digital health and biomarker technology-based company focused on autoimmune conditions, today announced a strategic collaboration to bring Progentec’s suite of proprietary biomarker blood tests for the proactive management of autoimmune diseases to market. The collaboration aims to increase accessibility for providers and patients across the U.S. and select global markets.
References
- Hammond ER, Desta B, Near AM, Wang X, Jiang M. Frequency, severity and costs of flares increase with disease severity in newly diagnosed systemic lupus erythematosus: a real-world cohort study, United States, 2004-2015. Lupus Sci Med. 2021 Sep;8(1):e000504. doi:10.1136/lupus-2021-000504. PMID: 34556546; PMCID: PMC8461688.
- Adamichou C, Bertsias G. Flares in systemic lupus erythematosus: diagnosis, risk factors and preventive strategies. Mediterr J Rheumatol. 2017 Mar 28;28(1):4-12. doi:10.31138/mjr.28.1.4. PMID: 32185248; PMCID: PMC7045928.
- Zen M, Saccon F, Gatto M, Montesso G, Larosa M, Benvenuti F, Iaccarino L, Doria A. Prevalence and predictors of flare after immunosuppressant discontinuation in patients with systemic lupus erythematosus in remission. Rheumatology (Oxford). 2020 Jul 1;59(7):1591-1598. doi:10.1093/rheumatology/kez422. PMID: 31642908.
- Munroe M, Blankenship D, DeFreese D, Holloway A, Purushothaman M, DeJager W, Macwana S, Guthridge J, Kamp S, Redinger N, Aberle T, Chakravarty E, Arriens C, Li Y, Zeng H, Dezzutti S,Izmirly P, Thanarajasingam U, Kamen D, Buyon J, James J, Jupe E. A refined disease activity immune index informed by select immune mediators that characterizes clinical disease activity in systemic lupus erythematosus [abstract]. Arthritis Rheumatol. 2023; 75 (suppl 9).
- Munroe M, DeJager W, Macwana S, Tran L, Guthridge J, Jupe E, DeFreese D, Newhardt R, Purushothaman M, Sharma S, Redinger N, Aberle T, Kamp S, Arriens C, Chakravarty E, Merrill J, James J. Ability of innate, adaptive, and TNF-superfamily immune pathways to characterize disease activity and inform a refined lupus disease activity immune index in a confirmatory cohort of SLE patients [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10).
- Munroe M, Guthridge J, Lu R, Kheir J, Adebayo B, Macwana S, Chen H, Roberts VC, Purushothaman M, Sharma S, Aberle T, Kamp S, Arriens C, Chakravarty E, Thanou K, Merrill JT, James JA. Innate, adaptive, and TNF-Superfamily immune pathways inform a lupus disease activity immune index that characterizes disease activity in SLE [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9).
- Munroe ME, Blankenship D, DeFreese D, Purushothaman M, DeJager W, Macwana S, Guthridge JM, Kamp S, Redinger N, Aberle T, Chakravarty EF, Arriens C, Li Y, Zeng H, McCarthy-Fruin KA, Osei-Onomahm S-A, Thanarajasingam U, James JA, Jupe E. (2023), A Flare Risk Index Informed by Select Immune Mediators in Systemic Lupus Erythematosus. Arthritis Rheumatol, 75: 723-735. https://doi.org/10.1002/art.42389.
- Thanou A, Jupe E, Purushothaman M, Niewold TB, Munroe ME. Clinical disease activity and flare in SLE: Current concepts and novel biomarkers. Journal of Autoimmunity. Volume 119. 2021, 102615, ISSN 0896-8411. https://doi.org/10.1016/j.jaut.2021.102615.
- Munroe ME,Vista ES, Merrill JT, Guthridge JM, Roberts VC, James JA. (2017), Pathways of impending disease flare in African-American systemic lupus erythematosus patients. J Autoimmun. 78:70-78. PMCID: PMC5340190.
- Munroe ME, Vista ES, Guthridge JM, Thompson LF, Merrill JT, James JA. (2014), Pro-inflammatory adaptive cytokines and shed tumor necrosis factor receptors are elevated preceding systemic lupus erythematosus disease flare. Arthritis Rheumatol, 66(7):1888-99. PMCID: PMC4128244.