Veracyte says new data confirming the analytical validity of its Envisia Genomic Classifier demonstrate its benefits in diagnosing idiopathic pulmonary fibrosis (IPF).
The study, “Analytical performance of Envisia: a genomic classifier for usual interstitial pneumonia,” published in the journal BMC Pulmonary Medicine, showed that the Envisia genetic test retained its accuracy and specificity even when used with low amounts of biological samples and in the presence of contaminated blood.
“These new data underscore the scientific rigor behind the Envisia Genomic Classifier and should give physicians and their patients even more confidence in the test’s results,” Dr. Giulia C. Kennedy, chief scientific officer of Veracyte, said in a press release.
The Envisia Genomic Classifier helps clinicians differentiate between IPF and other lung diseases. Commonly, IPF diagnosis requires invasive surgical procedures, but this new approach makes it possible to recognize IPF based on genetic patterns.
The test analyzes the RNA sequence of 190 genes to detect the presence or absence of usual interstitial pneumonia (UIP), a well-known hallmark of IPF. To perform this analysis, small lung tissue samples are collected via bronchoscopy, a less invasive method than surgery.
“By providing information that until now could only be obtained through diagnostic surgery, the Envisia classifier should help patients with suspected IPF get clearer answers faster so that they can receive the treatment they need — and avoid potentially harmful invasive procedures,” Kennedy said.
Results of a previous study showed that the Envisia classifier could effectively distinguish patients who had UIP from those who did not. Its diagnostic capacity was found to be even more accurate than that obtained with currently used methods.
This latest Veracyte study found the Envisia classifier performs accurately and reliably. It delivers valid data even when challenged by lab conditions and variables such as samples handling, RNA sample quantity, and blood and DNA contamination.
“To ensure patient safety and efficacy, a laboratory-developed test must meet strict regulatory requirements for accuracy, reproducibility and robustness,” researchers wrote. “We demonstrated that the Envisia test is analytically robust for use in the routine clinical care of patients under evaluation for suspected ILD [interstitial lung disease].”