Clinical Validation
Clinical Utility
Evidence Library
EXPLORE EVIDENCE

Clinical validation 

study results

Confidently identify UIP missed by HRCT with high accuracy

Envisia classifier combined with high resolution CT identified twice as many UIP patients than radiology alone.1

In two independent, prospective multicenter validation trials, Envisia classifier identified UIP with a combined 97% specificity compared to histopathology.1,2

Pivotal validation study
Second validation study
Bar graph showing the sensitivity of different UIP detection methods. HRCT alone has a sensitivity of 34%. This is increase twofold is Envisia is used alone or in combination with HRCT, with a sensitivity of 63% and 79% respectively
Row of icons of people, of which 9 out of 10 are green indicating 91% specificity of the Envisia test
Bar graph that shows consistent specificity of about 90% across gender, age, and smoking status.

Envisia classifier demonstrates consistent performance across gender, age, and smoking status

The Envisia Genomic classifier achieved 91% specificity and 63% sensitivity on 144 patients combining two prospective validation cohorts. This performance is retained across gender, age group and smoking status.

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References

1.  Richeldi L, et al. ATS Journals. Jul 2020.
2. Raghu G, et al. Lancet Respiratory Medicine. Apr 2019.