What is Envisia (Thyroid Eye Disease) testing?

From the Guidelines

Envisia testing is not recommended for diagnosing dry eye syndrome or its underlying conditions, as it is not mentioned in the provided evidence. The evidence provided focuses on diagnostic tests for possible underlying systemic conditions in patients with dry eye, such as Sjögren’s syndrome, thyroid eye disease, sarcoidosis, and ocular mucous membrane pemphigoid 1. For patients with suspected Sjögren’s syndrome, a serological examination for anti-Sjögren syndrome A antibody (SSA or anti-Ro), anti-Sjögren syndrome B antibody (SSB or anti-La), rheumatoid factor, and antinuclear antibody should be ordered 1. Some key points to consider when evaluating dry eye syndrome include:

• Using a point-of-care test that includes traditional serology as well as additional biomarkers (salivary protein 1 [SP1], carbonic anhydrase 6 [CA6] and parotid secretory protein [PSP]) for Sjögren’s syndrome 1
• Ordering antithyroid peroxidase antibody and antithyroglobulin antibody tests for patients who might have thyroid eye disease 1
• Using orbital imaging, such as CT or MRI scans, to assess extraocular muscle thickening in patients with thyroid disease 1
• Considering conjunctival biopsy for patients with significant chronic conjunctivitis with a nodular appearance or cicatrization (subepithelial fibrosis or fornix foreshortening) 1
• Utilizing new imaging devices, such as placido-ring corneal topographers and color cameras, to evaluate the health of the ocular surface 1.

From the Research

Envisia Testing Overview

• Envisia is a molecular classifier that identifies usual interstitial pneumonia (UIP) in transbronchial lung biopsy samples 2, 3, 4.
• The test has been shown to have high specificity and sensitivity in detecting UIP, with a specificity of 92.1% and a sensitivity of 60.3% in one study 2.
• Envisia can be used in conjunction with high-resolution computed tomography (HRCT) to improve the accuracy of UIP diagnosis, with a sensitivity of 79.2% and a specificity of 90.6% when used together 2.

Clinical Utility of Envisia Testing

• The Envisia classifier has been shown to increase the number of idiopathic pulmonary fibrosis (IPF) diagnoses, with an absolute difference of 39% in one study 3.
• The test also increases diagnostic confidence, with high confidence (⩾90%) of interstitial lung disease diagnoses more commonly seen with Envisia in both the pre-post cohort and in the independent cohorts 3.
• Recommendation for antifibrotic treatment also increases with Envisia, with an absolute difference of 36% in one study 3.

Analytical Performance of Envisia Testing

• The Envisia test has been shown to have robust analytical performance, with stability of RNA in transbronchial biopsies during collection and shipment, and tolerance to variation in RNA input and potentially interfering substances such as blood and genomic DNA 5.
• The test is also reproducible from RNA extraction through to Envisia test result, with a standard deviation of 0.20 for Envisia classification scores on a > 7-unit scale 5.

Comparison with Other Diagnostic Methods

• Envisia has been compared to HRCT and histopathology in the diagnosis of UIP, with the test showing high agreement with histopathology results and improved diagnostic confidence compared to HRCT alone 2, 4.
• The test has also been shown to be useful in patients with possible or inconsistent UIP on HRCT, with a positive predictive value of 81% for underlying biopsy-proven UIP 4.