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Veracyte Builds Data for Lung Cancer Swab Test, Begins Limited Launch

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NEW YORK – Molecular diagnostics firm Veracyte has begun providing its nasal swab-based lung cancer test to a limited number of early adopter clinical sites as it builds utility data to support broad reimbursement.

The move comes alongside new performance data for the Percepta assay, which investigators presented earlier this month at the 2021 American College of Chest Physicians (CHEST) annual meeting, held virtually. According to the company, the updated evidence adds new support for the ability of the test to assess disease risk across different nodule sizes and cancer stages in current or former smokers, and for patients who have already had other cancers.

The Percepta Nasal Swab assay 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.

The assay joins Veracyte's previously launched Percepta Genomic Sequencing Classifier — which is performed on samples taken during a bronchoscopy — and uses the same basic approach, measuring gene expression signals associated with cancer-related tissue damage in the lungs.

Presenting the new data in an oral session at the meeting this month, Carla Lamb, an interventional pulmonologist at Lahey Hospital & Medical Center, highlighted the fact that physicians currently have limited tools, especially objective tools, to determine whether or not patients with lung nodules discovered on imaging have cancer.

"This uncertainty can lead to unnecessary diagnostic procedures or to potentially delayed diagnosis and treatment," she said in a statement.

Veracyte's early data on the Percepta nasal swab test was generated from a blinded set of samples from 249 patients, all current or former smokers undergoing evaluation for lung nodules found on CT scans. Patients were followed for up to one year or until physicians made a final, adjudicated diagnosis.

The new expanded data presented at the CHEST meeting incorporated an additional 63 patients with prior cancers elsewhere in the body who were part of a planned secondary endpoint analysis.

In this overall cohort of 312 patients, the investigators calculated that the Percepta swab test had a sensitivity of 97 percent in marking patients as low risk for cancer. This translated to a negative predictive value of about 98 percent, assuming a 25 percent cancer prevalence in the target population of individuals with CT-identified nodules.

At the same assumed disease rate, the researchers calculated that the test's 92 percent specificity for calling high-risk nodules would yield a positive predictive value of 70 percent for the detection of malignancies.

Finally, in a sub-analysis of the cohort, the researchers measured the test’s performance across different nodule sizes and cancer stages. According to the team, the test marked 100 percent of large cancerous nodules as either high or moderate risk and showed similar performance in cancers that were stage II and above.

"What I think is really noteworthy is that [we've been able to show] very high sensitivity for calling a patient low risk," Giulia Kennedy, Veracyte's CSO and chief medical officer, said in an interview.

At the same time, the assay was able to maintain high specificity, she added. "One of the issues with CT screening is that it's sensitive, but it's not specific, so a lot of people get worked up for nodules that really aren't cancer. We are covering both ends of that spectrum really, really well," Kennedy said.

Alongside the nasal swab and GSC assays, Veracyte also has plans to validate and release a complementary tissue-based test, the Percepta Genomic Atlas, to be used to inform treatment decisions for patients who have been diagnosed with lung cancer via a biopsy.

The company is not alone in targeting multiple decision points in the lung cancer diagnosis and treatment process. But few other firms offer tests in the early, noninvasive diagnostic space. Biodesix, for example, has been successful in bringing a pair of proteomic products to market for assessing CT-detected nodules. The company's Nodify XL2 assay received a local coverage determination from its Medicare contractor Noridian for use in the management of lung nodules between 8 and 30 mm in diameter, and in patients 40 years or older and with a pre-test cancer risk of 50 percent or less.

Oncocyte, once also a potential competitor in this niche, saw its efforts to launch a noninvasive nodule assessment assay fall through in 2020.

Veracyte CEO Mark Stapley said that his firm has successfully validated the Percepta swab test for clinical provision to customers through its CLIA lab. He didn’t name early adopters but said the company is doing a "phased launch" in a small number of sites, which will allow it to gather the clinical utility evidence needed to drive reimbursement.

"We've met all of our key [performance] milestones so now it's getting it in the hands of these sites and in the noses of patients," he said.

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