Veracyte announces IVD agreement with Illumina

December 2023—Veracyte has entered into a multiyear agreement with Illumina to develop and offer some of its high-performing molecular tests as decentralized in vitro diagnostic tests on Illumina’s NextSeq 550D× next-generation sequencing instrument. The agreement is part of Veracyte’s expanded, multiplatform IVD approach, which will also include qPCR.

The company plans to develop its Prosigna breast cancer assay and Percepta nasal swab test for the NextSeq 550D×. Prosigna is commercially available as an IVD test that helps inform treatment decisions for patients with early-stage breast cancer. The Percepta nasal swab test is intended to help guide diagnosis and treatment decisions for current and former smokers who have lung nodules that are potentially cancerous.

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.

Veracyte, 650-243-6300