The test is based on RNA sequencing and is used to differentiate between idiopathic pulmonary fibrosis and other lung diseases in order to avoid surgery.
The study supports the use of Envisia to help with the diagnosis of idiopathic pulmonary fibrosis, particularly in patients without a clear radiological result.
The LCD will enable coverage of Envisia in patients for whom imaging does not lead to a definitive diagnosis of idiopathic pulmonary fibrosis.
The company is currently conducting clinical studies to validate AlloSure's technology — which underlies its kidney transplant test — in lung transplant patients.
The company said that 20 medical centers in the US are now offering the Envisia Genomic Classifier through an early-access program begun in May.
ProAxsis and a US-based biotechnology company codeveloped the assay as part of an ongoing collaboration. ProAxsis has made its first commercial sale of the test.
Investigators concluded that wearables show early promise in some cases, but there's limited evidence to substantiate claims of their ability to improve outcomes.