organ transplant

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.

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. 

The technology uses Thermo Fisher Scientific microarrays to measure transcript levels in order to diagnose rejection of solid organ transplants.

The company said revenues for the quarter and full-year 2016 included sales of Olerup HLA typing products, which CareDx got through its acquisition of Allenex.

The test is the first to be available worldwide that evaluates a metabolic biomarker network for diagnosing acute rejection following a transplant.