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Invivoscribe Gets CE Mark for NGS LymphoTrack Assays

NEW YORK (GenomeWeb) – Invivoscribe has received CE marking and launched next-generation sequencing-based assays for detecting clonality in hematological malignancies.

The LymphoTrack Dx TRG assay assesses T-cell receptor gamma rearrangements, while the LymphoTrack DX IGH FR1 assay assesses immunoglobulin heavy chain gene rearrangements.

They both have CE marking to run on either Illumina's MiSeq or Thermo Fisher's Ion PGM, and are designed to help oncologists track clonality to help in diagnosis and management of hematological malignancies by confirming or ruling out neoplasms.

The IGH assay can also provide prognostic information for patients with chronic lymphocytic leukemia because it can determine the somatic hypermutation status, identify stop codons, and confirm presence of open reading frames in the IGH gene. In addition, it can define V and J gene usage of tumor-associated clonal IGHV gene rearrangements, which are associated with poor prognosis in CLL.

The kits include the reagents and the company's proprietary LymphoTrack Dx software. According to the company, the software can analyze 1 million sequencing reads in approximately 90 seconds. Each kit also includes one-step PCR master mixes with either 12 or 24 individual indices for the PGM and MiSeq, respectively.

The tests "enable clinicians to identify and monitor patient- and tumor-specific biomarkers, which, in turn, allows them to more effectively personalize treatment for each patient," Invivoscribe CEO and CSO Jeffrey Miller said in a statement.

The company said it plans to launch additional CE-marked LymphoTrack Dx assays this year.