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Veracyte to Launch Updated Lung Cancer Test This Year; Makes Progress in Early Detection Assay

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SAN FRANCISCO (GenomeWeb) – Veracyte plans to launch an updated version of its Percepta Bronchial Genomic Classifier lung cancer assay mid-year, the company said this week.

During a conference call discussing its first quarter 2019 earnings, CEO and Chairman Bonnie Anderson said that the firm had made significant progress in its collaboration with Johnson & Johnson to develop the optimized Percepta test, which is used in conjunction with bronchoscopy to rule out cancer in lung nodules.  

Anderson said the company had also made progress in developing a less invasive lung cancer detection genomic classifier from a nasal swab.

"We achieved key milestones ahead of plan" for both the second-generation Percepta test and the nasal swab test for lung cancer, Anderson said. She said that the collaboration with Johnson & Johnson has brought "more patient samples and resources to bear on our efforts" and that the firm has now "optimized the Percepta classifier," which is based on whole-transcriptome sequencing, and plans to launch the updated assay in the middle of the year.

Veractye launched its initial Percepta assay in 2015, and Anderson said the firm expects to double the number of Percepta tests run in 2019 over 2018 to more than 3,000. The assay "continued to gain momentum" in the first quarter of 2019, with test volumes increasing 195 percent year over year.

With regards to the nasal swab test for early detection, Anderson said that company researchers are currently in the process of sequencing clinical samples and developing the machine learning tools for detecting early signs of lung cancer and will reveal "early cross-validation data before the end of the year." With the data release, the company will also discuss its plans for how it plans to position the test within the current clinical care paradigm, Anderson said, adding that it will also increase Veracyte's total addressable market to more than $30 billion.

During Q1, the company made significant progress in the commercialization of its newest test, Envisia Genomic Classifier, which is used to aid in diagnosis of idiopathic pulmonary fibrosis (IPF). As previously reported, the company published clinical validation and utility data on Envisia, secured Medicare coverage through Palmetto GBA MolDx, and received regulatory approval for the assay from the New York State Department of Health.

Due to these trends, the company anticipates running between 500 and 1,000 Envisia tests during the year. Anderson said that the firm plans to drive growth of the test incrementally with its pulmonology team initially focused on selling it to additional physicians within its 33 early access sites as well as expanding more broadly outside of those sites.

In addition, Anderson said that the firm would also continue to keep its eye on several ongoing drug trials for IPF for potential opportunities to partner with pharmaceutical companies. Many of the compounds being developed require a diagnosis of IPF, but getting a diagnosis through standard-of-care imaging tests can be difficult. Envisia is positioned as a diagnostic aid to such imaging tests, and so could be "nicely positioned to change the landscape and help more patients get enrolled in these trials," Anderson said. Envisia "can help make a diagnosis even when the [imaging test] is not confident."

Veracyte's most mature product lines are its Afirma assays to help distinguish benign from cancerous thyroid nodules. The test is run when cytology results are uncertain.

With the transition of customers from the first generation Afirma Gene Expression Classifier to its second-generation Afirma Genomic Classifier completed by the end of last year, Anderson said that customers are now seeing real benefit from the updated test. For instance, researchers from Brigham & Women's Hospital published a study in March in the journal Thyroid showing that the Afirma GSC identified 40 percent more benign thyroid nodules compared to the first version of the test, helping those patients avoid unnecessary surgery. And last month, Anderson noted, Veracyte researchers described in BMC Systems Biology the use of Afirma GSC for diagnosing a particularly challenging-to-diagnose type of thyroid cancer found in Hürthle cells. The original classifier "defaulted to a suspicious result for this subtype," Anderson said. But, as described in the recent study, the new classifier makes use of mitochondrial data to distinguish benign subtypes, she said.

Furthermore, Anderson noted that the firm continued to make progress on the reimbursement front. Afirma GSC is now covered by the US Department of Defense's Tricare program, which covers nearly 9.4 million service members, retirees, and family members, she said. In addition, the company also struck a deal with Blue Cross Blue Shield of Tennessee to be an in-network service lab.