The new in vitro diagnostic (IVD) kit will be used in Lexent Bio’s next-generation sequencing (NGS)-based cancer diagnostics
Image: Illumina Building entrance. Photo: Courtesy of Illumina, Inc.
Lexent Bio, a San Francisco-based precision oncology company, has entered into a non-exclusive partnership with Illumina for the development of an in-vitro diagnostic (IVD) kit.
The IVD kit will be used in Lexent Bio’s future portfolio of next-generation sequencing (NGS)-based cancer diagnostics.
As per Lexent Bio, the IVD kit under development will expand the Lexent’s assay, currently being developed as Confera Dx for monitoring therapeutic response for patients with certain solid tumor cancers and for monitoring minimal residual disease.
The Confera Dx assay will be launched in the US as a laboratory developed test (LDT), with the distributable IVD kit to follow.
Lexent Bio expects that its Confera Dx response monitoring system is suited for distribution as an IVD kit with FDA clearance, making it available for hospitals and health systems to run in their local laboratories across the US and eventually around the world.
Lexent Bio CEO and cofounder Ken Nesmith said: “Lexent Bio is building tools that are specifically designed to monitor response to therapy in real time, and then detect minimal residual disease, in multiple solid tumor cancers, across therapeutic modalities.
“Enabling laboratories around the world to leverage their next-generation sequencing (NGS) capability and provide this assay locally will expand their ability to improve clinical practice with these tools.”
The IVD kit will run on Illumina’s NextSeq 550Dx System
Under the agreement, Lexent Bio will develop the IVD kit to run on Illumina’s NextSeq 550Dx System. The precision oncology company will be responsible for obtaining the necessary regulatory approvals for the IVD kit and its subsequent commercialisation.
Illumina will sell the NextSeq 550Dx System and the associated sequencing consumables with customer service and support as needed.
Illumina chief medical officer Dr. Phil Febbo said: “By making Lexent’s Confera Dx assay system accessible to patients, we hope to ensure health care providers have access to a valuable part of a growing genomics ecosystem. Partnerships that bring exceptional clinical content to customers and patients represent an exciting opportunity in clinical genomics.
“We are committed to accelerating the menu of clinical tests available on our diagnostic sequencing platforms and our work with Lexent Bio should result in expanded access to practice changing genomic-based testing in order to improve patient outcomes.”