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 said it expects fourth quarter revenues of $12.3 million to $12.5 million, a year-over-year increase of 13 percent to 15 percent.
Though revenues from its non-invasive heart transplant rejection test AlloMap fell about 5 percent, CareDx is already being reimbursed by Medicare for its new AlloSure test.
At the recent IDWeek conference, company collaborators presented early validation data on a blood-based assay for cell-free microbial DNA.
The firm's CEO said that its assay is applicable in other indications where immunosuppressive therapies are used, such as rheumatoid arthritis.
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 company said revenues from its non-invasive heart transplant rejection test AlloMap rose about 16 percent year over year.
The company said that it is extending the maturity of certain obligations under the terms of the acquisition deal until March 2019.
The kit was previously approved by FDA for use on Qiagen's Rotor-Gene Q real-time PCR platform, which is one component of the automated QiaSymphony platform.