Research Findings Show That Veracyte’s Molecular Classifier Improves Non-Surgical IPF Diagnosis Using Bronchoscopy Samples

Research Findings Show That Veracyte’s Molecular Classifier Improves Non-Surgical IPF Diagnosis Using Bronchoscopy Samples

This week at the American Thoracic Society 2015 International Conference in Denver, Veracyte, Inc., a diagnostic company based in San Francisco, presented preliminary data showing that the company’s molecular classifier successfully distinguished idiopathic pulmonary fibrosis (IPF) from other interstitial lung diseases (ILDs) using samples obtained through bronchoscopy.  The presentation coincides with the company’s recently released study, entitled, “Classification of usual interstitial pneumonia in patients with interstitial lung disease: assessment of a machine learning approach using high-dimensional transcriptional data,” published in the latest edition of The Lancet Respiratory Medicine.

About Idiopathic Pulmonary Fibrosis

IPF is a chronic disease that results in a scarring and thickening of lung tissue, without a known cause.  It is considered an orphan disease, meaning that it is extremely rare and its precise incidence and prevalence rates globally are unknown.  Studies have shown that the rates of IPF are increasing globally, and may not be considered rare in the near future. The unknown origin of the disease has led to speculation among scientists that it may be environmentally linked, in which case the lungs are responding to injury such as chronic cigarette smoking or exposure to chemicals. Genetic and immune dysfunction has also been thought to possibly play a role in disease manifestation.

About the Research

The research findings demonstrated that the Veracyte’s molecular classifier was able to distinguish the presence of a specific molecular pattern that is a hallmark of IPF pathology, by non-invasive methods.  This ability was tested using transbronchial bronchoscopy (TBB) procedure samples obtained from clinical patients with various interstitial lung diseases at 11 hospitals in North America.

The molecular classifier uses whole-genome data and disease histopathology to distinguish the pathological pattern of IPF with a specificity rate of 92%. This theoretically means that the classifier may be able to identify and distinguish IPF from other ILDs, including non-specific interstitial pneumonia, emphysema and organizing pneumonia.

In a previous statement about the diagnostic capabilities of the company’s molecular classifier, Bonnie Anderson, president and CEO of Veracyte said, “We are excited to share our first proof-of-concept data for the development of a molecular classifier designed to improve ILD diagnoses. These conditions are often very challenging to diagnose, and the ability to deliver an early differential diagnosis without risky, invasive surgery could lead to significant improvement in treatment decisions for patients with suspected ILDs. This need is increasingly critical as the pipeline for IPF therapies expands, making increased life expectancy and quality of life improvements a possibility for patients who are accurately diagnosed.”

In a recent company press release, Dr. Giulia C. Kennedy, Ph.D., chief scientific officer of Veracyte, and senior study author, stated, “The recent availability of therapies that slow progression of IPF makes improved diagnosis of this disease even more imperative. 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.”

Dr. Kennedy continued, “Taken together, findings from these studies confirm the potential of a genomic test to help physicians differentiate and diagnose IPF. 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.”

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