Lexent Bio Enters Partnership with Illumina to Develop an In Vitro Diagnostic Kit
SAN FRANCISCO, Nov. 8, 2019 /PRNewswire/ -- Lexent Bio, Inc., a precision oncology company developing novel liquid biopsy systems, today announced a non-exclusive partnership with Illumina, Inc., (NASDAQ: ILMN) to develop an in-vitro diagnostic (IVD) kit for Lexent's future portfolio of next-generation sequencing (NGS)-based cancer diagnostics.
The IVD kit under development will expand the availability of Lexent's assay, currently in development 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 market as a laboratory developed test (LDT) performed by Lexent in a CLIA-certified laboratory, with the distributable IVD kit to follow. Lexent believes the Confera Dx response monitoring system will be well 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 United States, and eventually around the world.
Under this agreement, Lexent will develop the IVD kit to run on Illumina's NextSeq™ 550Dx System. Lexent will be responsible for obtaining the necessary regulatory approvals for the IVD kit and for subsequent commercialization. Illumina will sell the NextSeq 550Dx System and associated sequencing consumables with customer service and support as needed.
"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," said Ken Nesmith, CEO and cofounder of Lexent Bio.
"Performing the assay locally will reduce turnaround time, getting answers to patients and clinicians faster, and will simplify assay integration into the local care team's workflow. Illumina is a global leader in NGS platforms, and we are delighted to join forces with them to develop this kind of IVD product," said Ted Snelgrove, Chief Business Officer of Lexent Bio.
"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," said Dr. Phil Febbo, Chief Medical Officer of Illumina. "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."
About Lexent Bio
Forward Looking Statements
SOURCE Lexent Bio
Company Codes: NASDAQ-NMS:ILMN