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Veracyte Announces In Vitro Diagnostic Agreement With Illumina

Double helix structure of DNA.
Credit: Sangharsh Lohakare / Unsplash.
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Veracyte, Inc. (Nasdaq: VCYT) announced that it has entered into a multi-year agreement with Illumina, Inc. (Nasdaq: ILMN) to develop and offer some of its high-performing molecular tests 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," said Marc Stapley, Veracyte’s chief executive officer. "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."

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The first tests that Veracyte plans to develop for the Illumina NextSeq 550Dx instrument are its Prosigna Breast Cancer Assay and Percepta Nasal Swab test. 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,” said Joydeep Goswami, chief financial officer and chief corporate development and strategy officer of Illumina. “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 ever-expanding pipeline of clinical applications in the fields of oncology, reproductive health, genetic diseases testing, and more. With regulatory approvals in over 60 countries, NextSeq 550Dx has become a trusted platform for hospitals and clinical laboratories running a menu of high-quality diagnostic tests.


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 of the U.S.