Precision oncology company Lexent Bio, which is developing liquid biopsy systems for the monitoring of cancer has announced a partnership with Illumina to develop an in vitro diagnostic kit for the monitoring of therapeutic response in patients with specific cancers and for monitoring minimal residual disease.
Typically, results regarding treatment efficacy are obtained by undergoing imaging methods every few months. But, Ken Nesmith, CEO and co-founder of Lexent explained that there are major limitations with this method. “You have to wait for big changes in order to understand what is happening” he explains. This is one of the reasons why Lexent wants to use blood tests to monitor therapeutic response for patients with certain solid tumor cancers and for monitoring minimal residual disease.
Lexent’s test, Confera Dx, is currently in development with the intention to be made available next year as a laboratory developed test (LDT) performed by Lexent in a CLIA-certified laboratory. Their hope is that a distributable in-vitro diagnostic (IVD) kit will follow.
Nesmith told Clinical OMICS that the IVD will “get answers to patients faster” by eliminating the need for shipping across the country. A lot of clinicians, he noted, “just don’t want to send things out across the country.” In addition, the lab performing the assay would be able to integrate the information into the patients’ treatment plans more easily. He said the test could be done every few weeks, if necessary.
Nesmith sees a particular usefulness for the test with the increasing use of new immunotherapies on the market. Sometimes, he noted, immunotherapy treatments work really well. But a patient’s response is both difficult to predict and takes a long time to realize. He hopes that Confera will be able to quickly discriminate responses to checkpoint inhibitors.
The test analyzes the whole genome and discerns the methylation patterns of cfDNA.
By quantifying the cfDNA, changes can be tracked over time. The technology behind the test was developed at the genetic screening company Counsyl in 2015. The team that has developed the liquid biopsy technology and cloud-based data and compute platform spun out of Counsyl and started Lexent in 2016.
Confera, which is currently only being used in a research basis, is expected to be made available for solid tumor cancers. Lexent hopes that the LDT kit will be available next year. The IVD kit, which requires FDA approval, will take much more time. A partnership with Illumina will certainly help the process. Under the 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 kit and for subsequent commercialization. Illumina, with a growing focus on clinical oncology, will sell the NextSeq 550Dx System and associated sequencing consumables with customer service and support as needed.
“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.
“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.
Nesmith explained that “it’s a big process to take something that runs in a central lab and enable it to be run as an IVD kit to be run in labs across the country.” But he adds that their technology “is well suited to that transition.” 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 Nesmith.