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CareDx Q3 Revenues Up 6 Percent

NEW YORK (GenomeWeb) - CareDx said after the close of the market on Wednesday that its revenues for the third quarter increased 7 percent year over year. 

For the three months ended Sept. 30, the Brisbane, California-based firm recorded $7.2 million in total revenues, up from $6.7 million in Q3 2014. It missed the consensus Wall Street estimate of $7.3 million. 

Testing revenue for the recently completed quarter was $7 million, up 6 percent from $6.6 million in the prior-year period, while collaboration and license revenues increased to $114,000 from $53,000. The firm said in a statement that it provided results for more than 3,400 AlloMap gene expression-based tests for heart transplant rejection in Q3 2015a record level. 

However, the firm had to respond to proposed changes to the Centers for Medicare & Medicaid Services (CMS) new Clinical Laboratory Fee Schedule for 2016, which would reduce reimbursement for several tests, including AlloMap. "Our attention at the end of the quarter shifted significantly to respond to the CMS proposal," CareDx CEO Peter Maag said in a statement. "We continue to work collaboratively with CMS and our advisors during the open comment period."

CareDx also said that it has enrolled more than 100 patients at 11 transplant centers for its DART kidney transplant study and remains on track to deliver an interim readout in the first half of 2016.

And in September, CareDx's donor-derived cell-free DNA assay was selected to be evaluated in a major multicenter study of clinical outcomes in kidney transplantation sponsored by the National Institutes of Health.

CareDx reported a net loss of $3.5 million, or $.29 per share compared to a profit of $1.2 million, or $.12 per share, in Q3 2014. It fell short of analysts' average estimate of a loss of $.25 per share. 

The firm's R&D spending more than doubled to $2.7 million from $1 million due to clinical trials activity, the firm said. SG&A expenses increased 45 percent to $5.4 million from $3.7 million.

The company ended Q3 with $34 million in cash and cash equivalents and confirmed its full-year 2015 revenue guidance of between $28 million and $30 million.