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Veracyte Receives Regulatory Authorisation to Offer Envisia Genomic Classifier for Patients in New York State.

M2 PHARMA-April 24, 2019-Veracyte Receives Regulatory Authorisation to Offer Envisia Genomic Classifier for Patients in New York State

(C)2019 M2 COMMUNICATIONS

- US-based genomic diagnostics company Veracyte, Inc. (NASDAQ: VCYT) has received regulatory authorisation from the New York State Department of Health to offer the Envisia Genomic Classifier for patients in the state effective immediately, the company said.

The genomic test is the first commercially available test to help distinguish idiopathic pulmonary fibrosis from other interstitial lung diseases, without the need for risky surgery.

Over 100,000 people in the United States have lung-scarring ILDs, including IPF, which is the deadliest type, and the number is rising.

While therapies are now available to slow progression of this deadly disease, 55 % of IPF/ILD patients reported being misdiagnosed at least once and, for one in five patients, accurate diagnosis took three or more years, according to a study by the Pulmonary Fibrosis Foundation.

Earlier this month, clinical validation and clinical utility data for the Envisia classifier were published in The Lancet Respiratory Medicine, demonstrating the test's ability to identify the telltale pattern of IPF, while minimising false positive results, and its usefulness in giving physicians more confidence in their diagnosis of patients being evaluated for interstitial lung disease, including IPF, without the need for surgery.

The Envisia classifier is used as a complement to high-resolution computed tomography.

Each year in the United States and Europe, up to 200,000 patients are evaluated for suspected interstitial lung disease, including idiopathic pulmonary fibrosis, which is among the most common, deadly and difficult to diagnose of these lung-scarring diseases.

Physicians routinely use high-resolution computed tomography along with a clinical work-up to help identify IPF, but this approach frequently provides inconclusive results, leading many patients to undergo invasive and potentially risky surgery for a more definitive diagnosis.

Other patients are too frail to undergo surgery and may never receive an accurate diagnosis, which can result in suboptimal and potentially harmful treatment.

The Envisia Genomic Classifier is the first commercially available test to improve the diagnosis of idiopathic pulmonary fibrosis. The genomic test enables physicians to more confidently differentiate IPF from other interstitial lung diseases, helping to guide an optimal patient treatment plan that can improve outcomes and reduce risk.

The Envisia classifier was developed using RNA whole-transcriptome sequencing and machine learning to identify the usual interstitial pneumonia pattern, which is a hallmark of IPF. The test assesses patient samples obtained through bronchoscopy, a nonsurgical procedure commonly used in lung evaluation, and is used as a complement to high-resolution computed tomography.

The Envisia classifier is proven to detect UIP with high correlation to the gold standard histopathology results read by ILD experts without the need for surgery.

Veracyte (NASDAQ: VCYT) is a leading genomic diagnostics company that improves patient care by providing trustworthy and actionable answers to challenging clinical questions.

The company's products uniquely combine advanced genomic technology, clinical science and machine learning to provide answers that give physicians and patients a clear path forward, informing both diagnosis and treatment decisions without the need for costly, risky surgeries that are often unnecessary.

Since its founding in 2008, Veracyte has commercialised three genomic tests, which are transforming the diagnosis of thyroid cancer, lung cancer and idiopathic pulmonary fibrosis.

Veracyte is based in South San Francisco, California.

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Date:Apr 24, 2019
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