NEW YORK – Diagnostics firm Veracyte is seeing progress in its efforts to advance a growing menu of lung cancer and lung disease assays, including its Envisia assay for interstitial lung disease, and its Percepta Nasal Swab assay for noninvasive lung cancer early detection.
During a call this week discussing the company's first quarter financial results, CEO Marc Stapley highlighted recently updated clinical practice guidelines from the American Thoracic Society, published online in the American Journal of Respiratory and Critical Care Medicine, which discuss the use of Veracyte's Envisia Genomic Classifier.
Developed using RNA whole-transcriptome sequencing, the test detects a genomic pattern of usual interstitial pneumonia (UIP), a major factor in differentiating idiopathic pulmonary fibrosis from other interstitial lung diseases.
In addition, a recent review article in AnnalsATS compared results from multiple recent studies of the test, concluding a sensitivity of 68 percent and a specificity of 92 percent in predicting the UIP pattern.
In an associated commentary, authors Alyson Wong and Jolene Fisher, from the University of British Columbia and University of Toronto respectively, wrote that the review "points to the exciting potential of genetic and molecular data in ILD diagnosis and a precision-based approach to our patients" but noted that "more studies will likely be needed before there is broader uptake."
Stapley said the three publications are important additions to the ongoing discussion around the assay's potential to help physicians to make a confident diagnosis of IPF without the need for invasive surgery.
According to the authors of the new guidelines, theirs is the first to discuss the appropriateness of genomic classifier testing in patients with ILD of unknown type.
The guideline committee made no recommendation for or against genomic classifier testing, "because of insufficient agreement among the committee members," the group wrote, adding that there were "two schools of thought."
"Those who favored genomic classifier testing believed that the high specificity provided important diagnostic information that … may reduce the need for additional sampling for histopathology diagnosis [while] those who argued against genomic classifier testing believed that a recommendation in favor of testing was premature."
Put to a vote, more than 40 percent of the guidelines committee endorsed genomic classifier testing in clinical practice, at least conditionally, with 6 percent recommending it strongly. In contrast, 12 percent of the group strongly recommended against testing.
The authors wrote that the evidence base for genomic testing in ILD currently suffers from wide confidence intervals due to the small study sizes. "Additional studies are needed to obtain more exact estimates of sensitivity and specificity. Research is also needed to improve the technique’s sensitivity, assess the downstream consequences of false-negative results … and determine the ability of genomic classifier testing to differentiate UIP related to IPF and UIP related to other types of ILD," the group argued.
"We look forward to continuing to engage with the pulmonology community to advance understanding of the role our test can play in patient care, and to further reinforce the evidence supporting our test's ability to positively impact patient outcomes," Stapley said during the company's call this week.
He highlighted a case story — of IPF patient Keith Boyle, whose persistent cough marked the start of a complex diagnostic journey. "After an initial incorrect diagnosis of pneumonia, Keith saw five pulmonologists and underwent additional tests over a span of 18 long months. Finally, his new pulmonologists at UCLA, an early user of Envisia, offered him our test," Stapley said.
Envisia confirmed an IPF diagnosis, offering clarity to the patient and his family, and raising Boyle's confidence in pursuing anti-fibrotic treatment that can be damaging in some other pulmonary conditions. Reaching a diagnosis also enabled him to join a lung transplant list.
As it seeks to expand use of Envisia, Veracyte is also making progress in other arms of its lung test portfolio, Stapley added.
The company is preparing to share new data on its Percepta Nasal Swab test at the American Thoracic Society annual meeting later this month from studies evaluating the ability of the assay to accurately assess lung cancer risk among current and former smokers with lung nodules, regardless of their smoking burden history.
The new data joins previous results, which supported an initial launch among early adopters late last year. Percepta Nasal Swab is intended to help physicians treat patients with lung nodules found during a CT scan, informing their decisions regarding which patients should proceed to further diagnostic workup and which may avoid these invasive procedures.
"While low-dose CT [screening] is very effective at identifying patients with potentially cancerous lung nodules, physicians need a more objective, accurate tool to determine next steps for those patients. This is when Nasal Swab comes in," Stapley said on the call this week.
Discussing the path forward to a broader launch, he added that Veracyte is seeing progress in enrollment of sites for its clinical utility study and making headway on its "path to reimbursement."
"We're going to spend time over the next couple of years continuing to build the … evidence that is needed, getting KOL support, working our way towards guidelines. All those things are tried and tested, well-proven paths to getting a test reimbursed, which clearly is the end goal here," he said.
Stapley confirmed that the relative contributions to the company's revenues from both Envisia and Percepta Nasal Swab remain small. COVID-19 especially impacted the firm's efforts for these newer tests, he said, given the types of physicians being targeted and the procedures associated.
Stapley noted, however, that Envisia grew "really nicely" in Q1 2022 compared to the same period last year, with a 27 percent increase in test volume.
"Getting those guidelines out with so much extensive discussion around Envisia and such a significant number of respondents actually recommending the use of Envisia, I think that's a really encouraging sign for that product," he said.
Finally, Stapley reiterated that Veracyte is also expecting to add to its lung portfolio this year with the launch of Percepta Genomic Atlas, a next-generation sequencing test intended to help physicians make informed treatment decisions for patients diagnosed with lung cancer.
Having evaluated the optimal use of the test to address unmet clinical needs, Stapley said Veracyte has decided to explore "novel channel opportunities" for the test based on the ability to analyze diagnostic bronchoscopy samples.
"This channel opportunity will take a number of quarters to evaluate so we hope to share more about this at a later date," he added.