Dendritics develops antibodies against immune system and other cells for the discovery of targets with high diagnostic, prognostic, and therapeutic potential.
The company outlined its plans to launch a kidney transplant rejection test that is based on cell-free DNA in 2019 and described its progress in breast cancer research.
Milwaukee, Wis.-based TAI Diagnostics is developing a PCR-based assay for cell-free DNA as a way to monitor the health of transplanted organs.
The firm's transplant allograft status test identifies genetic biomarkers that predict the likelihood of a patient's immune system to reject the organ over time.
Piper Jaffray analyst William Quirk said the pricing, which was much higher than expected, will help push CareDx toward profitability.
The final LCD covers AlloSure in renal allograft recipients who have a probability of active renal allograft rejection.
The software provides analysis of HLA typing by NGS on several platforms, including ones from Illumina, Thermo Fisher, and PacBio.
The company said revenues from its non-invasive heart transplant rejection test AlloMap rose about 16 percent year over year.
Linkage is now part of Thermo Fisher's transplant diagnostics business, One Lambda. Linkage's flagship product line is its real-time PCR technology, LinkSeq.
The FDA approved the real-time PCR-based test for use on the Cobas 6800 and 8800 systems to assess the response of transplant patients to treatments.