Invivoscribe to Launch Four Diagnostic Assays Following CE Mark Approval
Invivoscribe Technologies plans to launch four LymphoTrack Dx next-generation sequencing assays following receipt of CE Mark-approval for each product, the San Diego, Calif., devicemaker announced Tuesday. The test kits are just several of the clonal assays the company expects to launch this year.
The in vitro diagnostic tests detect T-cell receptor gamma and immunoglobulin heavy chain gene rearrangements for use in cancer monitoring. The assays are meant to be used with the company’s Illumina MiSeq and ThermoFisher Ion PGM instruments.
The devicemaker claims it used difficult-to-test formalin fixed paraffin embedded specimens on two of the assays — the LymphoTrack DX TRG and IGH FR1 test kits — to prove their validity.
The company is seeking FDA approval, a spokesman says. It markets assays in more than 50 countries. — Jason Scott