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
Lexent Bio is a precision oncology company. The company works to shrink cancer's role in our lives, first by helping patients and clinicians make better treatment decisions, faster. The Lexent Bio team hails from clinical, scientific, engineering, computer science, and business backgrounds, and share a passion for changing the way we understand and treat cancer. The company is taking on some of the hardest problems at the intersection of unexplored cancer biology, data science, and clinical medicine. The Confera™ Dx Assay system is the company's first product to move into commercialization.


Forward Looking Statements
This press release contains forward-looking statements that are based on management's beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding Lexent Bio's partnership with Illumina, ability to develop, commercialize and achieve market acceptance of current and planned products and services, research and development efforts, and other matters regarding business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. Be cautioned that forward-looking statements are based on a combination of facts and factors currently known and projections of the future, about which we cannot be certain.  As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law.

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SOURCE Lexent Bio

Company Codes: NASDAQ-NMS:ILMN

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