Sequenta Earns CLIA Certification
Sequenta, Inc. today announced it has received Clinical Laboratory Improvement Amendments (CLIA) certification for a clinical test based on the LymphoSIGHT™ platform, marking a critical milestone for the clinical use of this next generation sequencing method for the monitoring of blood cancers. Sequenta expects to launch its first commercial test in 2013.
Several recent studies demonstrate the LymphoSIGHT™ method is a significantly more sensitive tool than standard minimal residual disease (MRD) assays. Sequenta is initially focusing on the use of the LymphoSIGHT™ platform in acute lymphoblastic leukemia, mantle cell lymphoma and chronic lymphocytic leukemia and plans to expand to additional blood cancers.
“Full clonality analysis of immune cell repertoires will have applications in the diagnosis and management of many blood cancers,” said Sequenta CEO Tom Willis. “With CLIA certification, we are now able to use the LymphoSIGHT™ method and make these clinical tests available to the physician community.”
The LymphoSIGHT™ method utilizes a proprietary assay for the amplification and sequencing of immunoglobulin and T cell receptors, enabling ultra sensitive detection and monitoring of T and B cells. The platform leverages the power of next generation sequencing to detect 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 using the LymphoSIGHT™ platform have shown significantly improved sensitivity to detect residual disease compared to flow cytometry, with greatly improved workflows over current real time polymerase chain reaction assays (PCR).
In a recent study published in the journal BLOOD, the LymphoSIGHT™ method confirmed the presence of MRD in samples considered positive by flow cytometry and allele specific oligonucleotide PCR (ASO-PCR) and also revealed MRD in ten samples that were negative by flow cytometry (ten percent of the total) and three samples that were negative by ASO-PCR.
In a separate study also published in BLOOD, researchers used the LymphoSIGHT™ method to comprehensively analyze hundreds of thousands of cancer cells, describing for the first time ongoing and extensive clonal evolution at the IgH locus. Many of the undetected clones were present at concentrations below the level of detection of standard diagnostic methods.
Sequenta's first commercial test, ClonoSIGHTTM, will enable physicians to utilize this same technology as a clinical decision-making tool in their own practices and will be available for purchase in 2013.
CLIA are U.S. federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research.
About Sequenta, Inc.
Sequenta is a venture backed startup dedicated to improving patient care in diseases mediated by immune cells through measurements of lymphocyte diversity. It is commercializing its LymphoSIGHT™ platform for clinical use in minimal residual disease while continuing to validate the use of its technology in a diverse set of diseases. For more information, go to www.sequentainc.com.
Cook + Schmid