Sequenta has obtained clinical laboratory improvement amendments (CLIA) certification for its new clinical test, which is based on the LymphoSIGHT method.
The LymphoSIGHT platform, which utilizes a proprietary assay for the amplification and sequencing of immunoglobulin and T cell receptors, enables ultra sensitive detection and monitoring of T and B cells.
Previous clinical trials conducted on LymphoSIGHT platform have shown improved sensitivity to detect residual disease compared to flow cytometry, with greatly improved workflows over current real time polymerase chain reaction assays.
The test, ClonoSIGHT, will use the LymphoSIGHT platform for the detection of acute lymphoblastic leukemia, mantle cell lymphoma and chronic lymphocytic leukemia.
Sequenta CEO Tom Willis said full clonality analysis of immune cell repertoires will have applications in the diagnosis and management of many blood cancers.
"With CLIA certification, we are now able to use the LymphoSIGHT method and make these clinical tests available to the physician community," Willis added.