Capstone Study

Robust, real-world evidence confirms that AVISE testing enables decisive clinical action superior to the current standard of care (tANA) in the differential diagnosis for lupus.

 

New Patient Cohort (8,748)

Repeat Testing

3.5X less frequent
AVISE Lupus vs tANA tested patients

Length of follow up for all study outcomes was a mean of 285 days for AVISE and 305 days for tANA

9.8%

Positive AVISE Lupus Test Results

The study clearly establishes a link between the superiority of the AVISE test and the benefit to patients through early treatment intervention. Delayed diagnosis can lead to increased disease burden and diminished quality of life.

Repeat Testing

3.5X less frequent
AVISE Lupus vs tANA tested patients

Length of follow up for all study outcomes was a mean of 285 days for AVISE and 305 days for tANA

Diagnosis

6X greater odds

AVISE Lupus [+]1 vs traditional ANA [+]2 establishing SLE diagnosis following AVISE

Treatment Initiation

3X greater odds

AVISE Lupus [+]1 vs traditional ANA [+]2 initiating SLE treatment following AVISE

90.2%

Negative AVISE Lupus Test Results

The study demonstrated that a negative AVISE test is more conclusive than the standard of care, as it is reflected by the lower number of repeat testing and fewer follow-up visits. Convincingly ruling out lupus is often a critical step for achieving diagnostic clarity for the patient and reducing costs on the system.

Repeat Testing

3.5X less frequent
AVISE Lupus vs tANA tested patients

Length of follow up for all study outcomes was a mean of 285 days for AVISE and 305 days for tANA

Laboratory Cost

2X lower

AVISE Lupus [-] vs traditional ANA [-] in first six-month follow-up period

Follow-up Visits

1 fewer visit

AVISE Lupus [-] vs traditional ANA [-] in first sixth-month follow-up period

References:

  1. AVISE Lupus + = Tier 1 and Tier 2 Positive.
  2. tANA + = ANA (IFA) 1:160 ≥ and/or one or more of the following positive: anti-dsDNA, anti-smith.

  • Positive AVISE
    Lupus Test Results:

The study clearly establishes a link between the superiority of the AVISE test and the benefit to patients through early treatment intervention. Delayed diagnosis can lead to increased disease burden and diminished quality of life.

Diagnosis

6X greater odds

AVISE Lupus [+]1 vs traditional ANA [+]2 establishing SLE diagnosis following AVISE

Treatment Initiation

3X greater odds

AVISE Lupus [+]1 vs traditional ANA [+]2 initiating SLE treatment following AVISE

  • Negative AVISE
    Lupus Test Results:

The study demonstrated that a negative AVISE test is more conclusive than the standard of care, as it is reflected by the lower number of repeat testing and fewer follow-up visits. Convincingly ruling out lupus is often a critical step for achieving diagnostic clarity for the patient and reducing costs on the system.

Repeat Testing

3.5X less frequent

AVISE Lupus vs. traditional ANA tested patients in a mean 285 days of follow up for AVISE and 305 days of follow-up for tANA

Repeat Testing

3.5X less frequent

AVISE Lupus vs. traditional ANA tested patients in a mean 285 days of follow up for AVISE and 305 days of follow-up for tANA

Laboratory Cost

2X lower

AVISE Lupus [-] vs traditional ANA [-] in first six-month follow-up period

Follow-up Visits

1 fewer visits

AVISE Lupus [-] vs traditional ANA [-] in first sixth-month follow-up period

References:
1. AVISE Lupus + = Tier 1 and Tier 2 Positive.
2. tANA + = ANA (IFA) 1:160 ≥ and/or one or more of the following
positive: anti-dsDNA, anti-smith.

CAPSTONE STUDY

Complement Activation Products vs. Standard ANA Testing:  Treatment Outcomes, Diagnosis & Economic Impact in Lupus

Summary

The recently published CAPSTONE Study - the largest ever comparative utility study in lupus diagnostics - leveraged multiple external data sources from hundreds of rheumatologists in comparing diagnosis and treatment outcomes for new patients3 tested with AVISE Lupus and those tested with traditional ANA methods (tANA). The study demonstrated that AVISE Lupus testing is more clinically effective, both for patients who test positive and those who test negative as compared to the current standard of care.

Methods

Using electronic health record (EHR) data from 01/2016 to 12/2020, linked with medical and pharmacy claims extracted from Medicare and a large commercial payor database, two cohorts were established: the AVISE cohort and the tANA cohort. AVISE and tANA test results were classified as positive, negative, or indeterminate and stratified based on test results. Multivariable logistic regression was used to estimate odds ratios (OR) comparing the likelihood of SLE medication initiation and SLE diagnosis between the AVISE and tANA cohorts.

Conclusions

The significantly greater likelihood of SLE diagnosis and SLE medication initiation in AVISE positive vs. tANA positive patients demonstrates superior clinical actionability, potentially shortening the time to diagnosis. AVISE negative patients experienced a greater decrease in outpatient lab testing post-test relative to tANA negative patients, supporting the improved negative predictive value of AVISE vs. tANA.

Results

The main cohort included 21,827 AVISE testing episodes and 22,778 tANA testing episodes. A total of 2,437 (11.2%) patients tested positive by AVISE compared to 5,364 (23.6%) of tANA positive patients. Among patients with no baseline prescription for SLE medication(s), AVISE positive patients were more likely to initiate SLE medications compared to tANA positive patients (43% vs. 32%, OR = 1.57, 95% CI 1.41-1.76). The treatment effect was larger in patients new to the practice within the preceding year, 55% vs. 33% (adjusted OR = 2.77, 95% CI 2.31-3.32). AVISE positive patients were over five-fold more likely to be diagnosed with SLE as compared to the tANA patients, 31% vs. 8% (OR = 5.11, 95% CI 4.43-5.89), and similar in the new patient cohort 30% vs. 6% (OR = 6.34, 95% CI 5.12-7.86). Linked EHR-Medicare data revealed a greater decrease in post-test vs. pre-test mean annualized outpatient lab testing in AVISE negative (-$985, p < 0.0001) vs. tANA negative (-$356, p<0.0001) patients.

References:

  1. AVISE Lupus + = Tier 1 and Tier 2 Positive.
  2. tANA + = ANA (IFA) 1:160 ≥ and/or one or more of the following positive: anti-dsDNA, anti-smith.
  3. Received a new patient consultation within 12 months of testing.

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