The technology being developed at the liquid biopsy company Lexent Bio is designed to help cancer patients. Rather than a focus on diagnostics, they are developing tools that they hope will help cancer patients understand if their cancer is responding to treatment or not.

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 said. 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, 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. In order to create the IVD kits, Lexent recently announced a nonexclusive partnership with Illumina to develop the kits.

Nesmith told GEN 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 noted that 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 on 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. “Illumina is a global leader in next-generation sequencing (NGS) platforms, and we are delighted to join forces with them to develop this kind of IVD product,” said Ted Snelgrove, CBO 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 added that their technology “is well suited to that transition.” Enabling laboratories around the world to leverage their NGS capability and provide this assay locally “will expand their ability to improve clinical practice with these tools,” said Nesmith.

 

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