Veracyte Expanding Diagnostic Test Availability With Illumina Agreement

Veracyte Inc. has entered into a multi-year agreement with Illumina Inc. to develop and offer some of its high-performing molecular assays as decentralized in-vitro diagnostic (IVD) tests on Illumina’s NextSeq 550Dx next-generation sequencing (NGS) instrument. The agreement is part of Veracyte’s expanded, multi-platform IVD approach, which will also include qPCR and is designed to accelerate the company’s ability to make its tests available to more patients globally.
 
“By expanding our IVD strategy to include established NGS and qPCR technologies, we believe we can help even more physicians and patients make better diagnostic and treatment decisions using our tests,” Veracyte CEO Marc Stapley said. “With its significant and growing installed base of NGS IVD instruments, Illumina is a natural partner to help us achieve our vision of transforming cancer care for patients all over the world.”
 
Veracyte first plans to develop its Prosigna Breast Cancer Assay and Percepta Nasal Swab test for the Illumina NextSeq 550Dx instrument. Prosigna is already commercially available as an IVD test that helps inform treatment decisions for patients with early-stage breast cancer. The noninvasive Percepta Nasal Swab test is intended to help guide diagnosis and treatment decisions for current and former smokers with lung nodules that are potentially cancerous.
 
“We are pleased to partner with Veracyte, with its high-performing tests in some of the world’s most prevalent cancers, to expand the reach of NGS-based molecular testing in cancer care,” Illumina Chief Financial Officer/Chief Corporate Development and Strategy Officer Joydeep Goswami stated. “We believe that enabling hospitals and laboratories to perform advanced molecular testing locally will significantly broaden market access and enable faster turnaround times so that patients and physicians can make better informed and timely decisions.”
 
Illumina’s NextSeq 550Dx instrument offers a validated mid-throughput platform and provides access to an expanding pipeline of clinical applications in oncology, reproductive health, and genetic diseases testing, among others. It has gained regulatory approvals in more than 60 countries.
 
Veracyte is also developing its Decipher Prostate Genomic Classifier, currently available in the United States through its CLIA laboratory, as a qPCR-based test for use outside the United States.
 
Veracyte is a global diagnostics company whose tests enable clinicians to make more confident diagnostic, prognostic, and treatment decisions for such diseases as thyroid, prostate, breast, bladder and lung cancers, as well as interstitial lung diseases. In addition to commercializing its tests in the United States through central laboratories, the company also aims to deliver its tests to patients worldwide through a distributed model to laboratories that can perform them locally.