Veracyte and Illumina have signed a multi-year agreement for the development of molecular tests as decentralised in vitro diagnostic (IVD) tests.
Under the agreement, the companies will develop and provide the tests as decentralised IVD tests on Illumina's NextSeq 550Dx next-generation sequencing (NGS) instrument.
Part of Veracyte’s expanded, multi-platform IVD approach, the agreement will also consist of quantitative polymerase chain reaction (qPCR) and expedite the worldwide accessibility of its tests to a wider patient population.
Veracyte's initial development plans for the Illumina NextSeq 550Dx instrument include the Percepta Nasal Swab test and the Prosigna Breast Cancer Assay.
The Percepta Nasal Swab test is noninvasive and designed to assist in diagnosing and making treatment decisions for individuals who are current or former smokers with potentially cancerous lung nodules.
Prosigna is already available on the market as an IVD test that helps guide treatment decisions for individuals diagnosed with early-stage breast cancer.
Veracyte is in the process of transforming its Decipher Prostate Genomic Classifier, which is presently offered in the US, into a qPCR-based test to be used outside of the country.
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.”
The NextSeq 550Dx instrument provides a validated mid-throughput platform and offers access to a growing range of clinical applications in reproductive health, oncology and genetic disease testing.
It has regulatory approvals in more than 60 countries and is intended for hospitals and clinical laboratories running a menu of 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.”
