The current approach to diagnosing IPF requires careful review of high-resolution CT scan images of the lungs integrated with other data from history and physical exam and pulmonary function testing. Unfortunately, many patients are left with an uncertain diagnosis and require invasive testing such as a surgical lung biopsy. Current best practice has been to proceed with Video Assisted Thoracoscopic Surgery (VATS- surgery through two small holes in the chest).
Envisia Genomic Classifier
Until recently, bronchoscopic lung biopsy (biopsy of the lung done during bronchoscopy) did not have a role in the diagnosis of IPF. However, a new genetic test that can be done on samples collected at bronchoscopy may offer a less invasive approach in determining if IPF is present. The new test is called Envisia Genomic Classifier. It uses small pieces of lung tissue obtained during bronchoscopy and measures the RNA (genetic messages expressed in the lung tissue). In preliminary testing it performed very well.
What does this mean for patients that are currently being evaluated for IPF? In a small number of sites the new test will be available. Medicare has requested more data prior to a decision about payment for the test. We look forward to updated information and availability in the coming year. At present most patients will still need to proceed with surgical lung biopsy if their clinical and imaging data are not definitive for making the diagnosis of IPF.