Veracyte will offer its high-performing molecular tests as decentralised IVD tests on Illumina’s NextSeq 550Dx next-generation sequencing (NGS) instrument, starting with its Prosigna breast cancer assay and Percepta nasal swab test
NextSeq 550Dx is a validated mid-throughput platform. (Credit: Illumina, Inc.)
US-based diagnostics company Veracyte has partnered with biotechnology company Illumina to develop and market some of its high-performing molecular tests outside of the US.
Under the partnership, Veracyte will offer its high-performing molecular tests as decentralised IVD tests on Illumina’s NextSeq 550Dx next-generation sequencing (NGS) instrument.
The US diagnostics company plans to initially develop its Prosigna breast cancer assay and Percepta nasal swab test for the Illumina NextSeq 550Dx instrument.
Already commercially available as an IVD test, Prosigna breast cancer assay helps inform treatment decisions for patients with early-stage breast cancer.
Percepta is a non-invasive nasal swab test intended to help guide diagnosis and treatment decisions for current and former smokers with potentially cancerous lung nodules.
Veracyte CEO Marc Stapley said: “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.
“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 said the multi-year partnership with Illumina is part of its expanded, multi-platform IVD approach and includes its qPCR-based tests.
The company is developing the Decipher Prostate Genomic Classifier, which is currently available in the US through its CLIA laboratory, as a qPCR-based test for use outside of the US.
Illumina’s NextSeq 550Dx instrument leverages its sequencing by synthesis (SBS) technology, which uses a reversible-terminator method to detect single bases integrated into DNA strands.
It is a validated mid-throughput platform that provides access to wide-ranging applications in oncology, reproductive health, and genetic disease testing, among others.
The NGS system has received regulatory approvals in more than 60 countries, for use in hospitals and clinical laboratories to perform a list of high-quality diagnostic tests.
Illumina chief financial officer and chief corporate development and strategy officer Joydeep Goswami said: “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.
“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.”