Diagnosis and Tests

New Lab Test Identifies Lupus Flare Risk 12 Weeks in Advance

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New blood test, aiSLE™ DX Flare Risk Index, identifies lupus flare risk up to 12 weeks in advance. The lab test is now available for clinical use.

Note: Progentec Diagnostics, Inc., the company that developed aiSLEDX Flare Risk Index, also powers LupusCorner

Life with lupus comes with plenty of challenges. For too long, the unpredictability of flares has been one of them. But, a new blood test provides Lupus Warriors and their rheumatologists with insight into their future lupus flare risk.

The new lab test is called aiSLE™ DX Flare Risk Index — and it’s available now for your lupus treatment team to order and use.


About aiSLE DX Flare Risk Index

Test Purpose
  • Identify risk of immunologic SLE flare in the next 12 weeks
Sample Source
  • Blood
  • Risk score from artificial intelligence algorithm
  • Immunologic measures of 11 cytokines
lupus flare risk warriors top 3 challenges

Research and Development of aiSLE DX Flare Risk Index

Biomarkers are measurable substances in the body that indicate a future change. Based on current research, no single biomarker can accurately measure or predict changes in lupus. However, a number of regulatory and inflammatory biomarkers have been identified through prior research. Progentec built upon this research and used advanced statistical modeling to create the new test.

Three seminal studies supported the development of the aiSLE DX Flare Risk Index:

    1. A 2014 paper published in Arthritis and Rheumatology which found that levels of inflammatory and regulatory cytokines varied between flares and stable disease levels
    2. A 2017 publication in the Journal of Autoimmunity which showed the creation of lupus flare risk index based on the alterations in the balance of inflammatory and regulatory cytokines.
    3. A 2022 publication in Arthritis and Rheumatology which verified altered immune mediators associated with imminent disease flare and a subset improved the FRI to identify SLE patients at risk of imminent flare.

aiSLE DX measures the blood-based biomarkers that are measurably altered before the onset of lupus flare symptoms. Research originally focused on 52 soluble immune mediators, including cytokines and chemokines, in plasma before disease flares. Using artificial intelligence (AI) models to reduce statistical “noise,” the aiSLE DX Flare Risk Index panel was optimized to 11 biomarkers.


Data integrity and generalizability

Multiple clinical studies supported the development of the aiSLE DX Flare Risk Index. This research was conducted at several National Institutes of Health-designated Autoimmunity Centers of Excellence in the United States. Participants in the clinical studies:

  • contributed blood samples
  • had their lupus flare status assessed by a rheumatologist using the SLEDAI
    • SLEDAI is a rubric-based assessment that is the gold standard for measuring current lupus disease activity

People of diverse racial and ethnic backgrounds participated in the studies including European Americans, African Americans, and Native Americans



To measure the accuracy of aiSLE DX Flare Risk Index, the researchers calculated an odds ratio. The Odds Ratio (OR) calculated for pre-flare vs pre-nonflare patients with positive vs. negative score approaches 5.0 and is highly significant (p= 0.0015). This OR indicates that a person with a positive aiSLE DX Flare Risk Index score is over 5 times more likely to flare than a patient with a negative score. Additionally, a maximum of 97% sensitivity and 98% specificity was achieved after defining low, medium, and high FRI thresholds.

aiSLE DX Flare Risk Index is part of aiSLE MGMT, a modern approach to lupus care.

aiSLE MGMT combines laboratory and digital tools — including a patient app, smartwatch, and health coach access — to better manage lupus.

Stay tuned on our website and social platforms for more updates!


Clinical Reaction

According to an article in BioSpace about the launch of aiSLE DX Flare Risk Index, “this appears to be the first proactive test for lupus.”

Dr. Chaim Putterman, a professor of medicine and microbiology & immunology at the Albert Einstein College of Medicine, and a member of Progentec’s Scientific Advisory Board, said in a statement:

“Proactive treatment strategies based on the aiSLE™ DX Flare Risk Index result may help clinicians and patients reduce the negative impacts of lupus flares, which include organ damage, hospitalizations, and reductions in patient quality of life.”

aiSLE DX Flare Risk Index “has the potential to help rheumatologists better manage lupus symptoms in people with the disease,” according to a news release shared by the Lupus Foundation of America.

Looking to learn more? Check out aislemgmt.com


Biomarkers in Lupus

The study of lupus biomarkers to diagnose, monitor, and predict disease activity has become a priority. So what exactly is a biomarker?

According to NCBI, “based on scientific and clinical rationale, a biomarker is defined as a measurement, including but not limited to a genetic, biological, biochemical, molecular, or imaging event whose alterations correlate with the pathogenesis and/or manifestations of a disease and can be evaluated qualitatively and/or quantitatively in laboratories.”

Due to the complexity of systemic lupus erythematosus, biomarkers have become crucial to presenting disease mechanisms, evaluating patients, and dictating treatment options. Additionally, biomarkers can prove to be reliable indicators for patients that are at higher-risk of developing lupus, long before diagnosis.

Looking to learn more? Check out aislemgmt.com


Developing the aiSLE DX Disease Activity Index

The aiSLE™ DX tests were developed from studies of SLE patients presenting for treatment at several lupus Centers of Excellence in the United States. Studies to develop the disease activity test compared samples from patients with classified SLE with low disease activity (< 4, range 0-3) to active disease (≥4, range 4-30) as defined by the hybrid SLEDAI (hSLEDAI). The Disease Activity Index provides an objective measure of an SLE patient’s concurrent disease activity with high degrees of accuracy.

How It Works

A well-defined set of immune modulatory soluble mediators, including cytokines, chemokines, and soluble receptors shown to be associated with disease activity in plasma are examined in this test. Although any one individual biomarker might not be associated with disease activity, the panel of immune mediators examined in this test accurately and distinguishes patients with active clinical disease from those with low activity or quiescent disease in a simple blood test. Hybrid measures, like SELENA-SLEDAI and BILAG, are time consuming and require rheumatologists to assess physical symptoms and multiple laboratory tests. The aiSLE DX Disease Activity Test supports clinicians in the measurement of lupus disease activity and the assessment of treatments.



If you are interested in Progentec sending information to your rheumatologist, send us an email hello@lupuscorner.com!

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