On May 20, 2019 Veracyte, Inc. (Nasdaq: VCYT), a leading genomic diagnostics company, reported new data demonstrating that its next-generation Percepta Genomic Sequencing Classifier (GSC) provides expanded lung cancer risk information that can further guide next steps for patients with lung nodules (Press release, Veracyte, MAY 20, 2019, View Source [SID1234536483]).

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Researchers prospectively validated the Percepta GSC on 412 patients with lung nodules who had inconclusive results following bronchoscopy, a common nonsurgical procedure to diagnose lung cancer. Among patients with an "intermediate" pre-test risk of cancer – the group that accounts for the majority of lung nodules – the Percepta GSC demonstrated high accuracy when it down-classified patients to "low risk" for cancer (negative predictive value of 91 percent). The test also had a positive predictive value (PPV) of 65 percent when it up-classified patients to "high risk" for cancer. The American College of Chest Physicians recommends patients with a cancer risk of 65 percent or greater undergo surgical treatment.

The new findings will be shared this evening at a company event being held during the American Thoracic Society 2019 International Conference(ATS 2019) in Dallas.

"Determining whether lung nodules are benign or cancerous is often difficult, which can lead to unnecessary invasive procedures and treatment delays," said Giulia C. Kennedy, Ph.D., chief scientific and medical officer of Veracyte. "With its ability to both down-classify and up-classify patients with inconclusive lung nodules, the Percepta GSC should help physicians avoid invasive biopsies in patients who are at low risk of lung cancer, while helping to guide intervention steps for those at high risk."

The Percepta GSC utilizes novel "field of injury" science – which identifies genomic changes associated with lung cancer in current or former smokers using a simple brushing of the person’s airway. The test is also Veracyte’s third clinical classifier to be developed on the company’s novel RNA whole-transcriptome sequencing and machine learning platform. Veracyte plans to begin making the Percepta GSC available to physicians by the middle of 2019.

"We are excited to unveil our Percepta GSC, which we believe will improve diagnosis and treatment decisions for patients undergoing evaluation for lung cancer," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "Additionally, we believe that moving the Percepta classifier to our RNA whole-transcriptome sequencing platform – together with our Afirma and Envisia classifiers – will provide operational efficiencies and a robust foundation for continued innovation. This includes our development of the first nasal swab test for early lung cancer detection."

Lung cancer is the leading cause of cancer deaths worldwide. In the United States, lung cancer causes more than 154,000 deaths each year – more than the next three most prevalent cancers combined. Because lung cancer is difficult to diagnose before it has metastasized, only 16 percent of cases are detected at an early stage, when the disease is more treatable. Lung cancer’s five-year survival rate is only 18 percent, much lower than that of other common cancers. Approximately 80 percent of lung cancer deaths are caused by smoking. Veracyte estimates that approximately 350,000 bronchoscopies are currently performed each year to evaluate suspicious lung nodules for cancer and that up to 70 percent of these produce inconclusive results.

Also during the ATS 2019 conference, Kevin Flaherty, M.D., of the University of Michigan Health System, will present clinical utility data demonstrating that Veracyte’s Envisia Genomic Classifier improves diagnosis of idiopathic pulmonary fibrosis (Session D12, Abstract A5837). These data were published online in The Lancet Respiratory Medicine on April 1, 2019.