NEW YORK (GenomeWeb News) – Sequenta said today it has received CLIA certification for a clinical test based on in its immune repertoire sequencing-based technology called LymphoSight.
"Full clonality analysis of immune cell repertoires will have applications in the diagnosis and management of many blood cancers," Sequenta CEO Tom Willis said in a statement. "With CLIA certification, we are now able to use the LymphoSight method and make these clinical tests available to the physician community."
LymphoSight is a next-generation sequencing-based technology that uses a proprietary assay for amplifying and sequencing immunoglobulin and T cell receptors, allowing for the "ultra-sensitive" detection and monitoring of T and B cells. The technology, Sequenta said, detects individual B cells at levels "as low as one cell per million white blood cells using a universal reagent set and routinely available blood samples."
Previous results on LymphoSight have shown increased sensitivity compared to flow cytometry and improved workflows compared with PCR assays, Sequenta said. The South San Francisco, Calif.-based firm told GenomeWeb Daily News in January that it would spend 2012 clinically validating its technology with an eye toward introduction of tests for cancers in 2013.
The initial focus for the technology has been on blood cancers, such as acute lymphoblastic leukemia, mantle cell lymphoma, and chronic lymphocytic leukemia, Sequenta said today, and its first commercial test, ClonoSight, targeted for launch in 2013, will allow physicians to use the company's technology as a clinical tool in their own practices.