SOUTH SAN FRANCISCO, Calif., May 20, 2015 /PRNewswire/ -- Veracyte, Inc. (NASDAQ: VCYT) today presented preliminary data demonstrating the ability of the company's molecular classifier to help distinguish idiopathic pulmonary fibrosis (IPF) from other interstitial lung diseases (ILDs) using samples obtained through bronchoscopy. The findings suggest the classifier's potential to help thousands of patients avoid invasive, risky and expensive surgery to resolve ambiguity in IPF diagnosis – a frequent challenge for physicians and patients.
The data were presented today at the American Thoracic Society (ATS) 2015 International Conference in Denver, Colo. The presentation coincides with online publication in The Lancet Respiratory Medicine of an article detailing foundational work and results from an independent test set, which demonstrated classifier performance using patient tissue samples obtained through surgery.
The data shared at ATS today demonstrate the ability of a Veracyte molecular classifier to distinguish the presence of a specific pathology pattern that is a hallmark of IPF among samples obtained through transbronchial bronchoscopy (TBB). This pathology pattern – whose presence is essential to IPF diagnosis – is often difficult to distinguish without surgery. Using whole-genome data and classifiers trained by histopathology "truth," researchers developed a classifier that could distinguish this pattern with high specificity (92 percent), suggesting its ability to identify and distinguish IPF from other ILDs, including non-specific interstitial pneumonia, emphysema and organizing pneumonia.
Each year in the United States and Europe, up to 200,000 patients are suspected of having an ILD, including IPF, which is the most common and most deadly, and is difficult to diagnose.
"The recent availability of therapies that slow progression of IPF makes improved diagnosis of this disease even more imperative," said Giulia C. Kennedy, Ph.D., chief scientific officer of Veracyte, who presented the data. "The findings presented today suggest it is possible to develop a molecular test that will enable less invasive and more accurate diagnoses of IPF. These results move us one step closer to making such a test available to patients who could greatly benefit from it."
Concurrent with the ATS presentation, The Lancet Respiratory Medicine published results from key original proof-of-concept research validating Veracyte's rigorous genomic approach to IPF diagnosis. Using 125 surgical lung biopsy samples from 11 hospitals across North America, researchers performed a series of statistical analyses to confirm that a genomic signal differentiating IPF can be identified using trained genomic classifiers.
"Taken together, findings from these studies confirm the potential of a genomic test to help physicians differentiate and diagnose IPF," said Dr. Kennedy. "We look forward to further improving our molecular classifiers by increasing the number of patient samples and incorporating additional information, such as radiologic and clinical information, into the algorithm."
Veracyte (NASDAQ: VCYT) is pioneering the field of molecular cytology, focusing on genomic solutions that resolve diagnostic ambiguity and enable physicians to make more informed treatment decisions at an early stage in patient care. By improving preoperative diagnostic accuracy, the company aims to help patients avoid unnecessary invasive procedures while reducing healthcare costs. Veracyte's first commercial solution, the Afirma® Thyroid FNA Analysis, centers on the proprietary Afirma Gene Expression Classifier (GEC) to resolve ambiguity in diagnosis and is becoming a new standard of care in thyroid nodule assessment. The Afirma test is recommended in leading practice guidelines and is covered for nearly 150 million lives in the United States, including through Medicare and many commercial insurance plans. Veracyte intends to expand its molecular cytology franchise to other clinical areas, beginning with difficult-to-diagnose lung diseases. In April 2015, the company launched the Percepta™ Bronchial Genomic Classifier, a test to resolve preoperative ambiguity in lung nodules that are suspicious for cancer. Veracyte is also developing a second product in pulmonology, targeting interstitial lung diseases, including idiopathic pulmonary fibrosis. For more information, please visit www.veracyte.com.
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