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Caredx, Inc. Reports Third Quarter 2015 Financial Results

The following excerpt is from the company's SEC filing.

Brisbane, CANovember 11, 2015CareDx, Inc. (Nasdaq: CDNA), a molecular diagnostics company focused on the development and commercialization of clinically differentiated, high value, non-invasive surveillance solutions for transplant recipients, today reported financial results for the third quarter ended September 30, 2015.

Recent highlights:

Total revenues for the third quarter were $7.2 million, a year-over-year increase of 7%

Significant progress on AlloSure, the companys transplant surveillance solution under development based on cfDNA technology:

The DART clinical trial, an observational study designed to demonstrate the clinical performance characteristics of cell-free DNA (cfDNA) in detecting clinical and sub-clinical rejection in kidney allograft recipients, has enrolled more than 100 patients at 11 transplant centers. CareDx remains on track to deliver an interim read-out in the first half of next year.

CareDxs donor-derived cfDNA (dd-cfDNA) assay was selected for a major National Institutes of Health (NIH) funded, multicenter study of clinical outcomes in kidney transplantation, called CTOT 19.

Opened a dedicated CLIA lab space for AlloSure, which will enable CareDx to test samples from kidney transplant patients across the US.

Continued growth of AlloMap

, the Companys proprietary surveillance solution for heart transplant recipients:

Record volume of more than 3,400 AlloMap patient results provided, with a continued reimbursement rate of approximately 80% for all AlloMap results delivered through the 12 month period ended March 31st, 2015.

Announced new data related to the use of AlloMap

Score Variability (AMV) to predict the risk of future clinically significant events in heart transplant recipients, providing a new tool to facilitate improved patient management strategies.

Brought AlloMap reimbursement billing process in house, reducing overall costs of the reimbursement effort and increasing effectiveness through direct control over the entire process.

Actively responded to the proposal by the Centers for Medicare & Medicaid Services (CMS) for a new Clinical Laboratory Fee Schedule that would reduce the reimbursement for several advanced molecular diagnostic tests, including AlloMap, in 2016.

We made important progress in the third quarter on each of our three strategic objectives for 2015, including further development of cfDNA tests for transplantation, increasing patient adoption of AlloMap as a surveillance tool in heart transplantation, and pursuing inorganic growth opportunities. We continued to execute on the clinical development milestones we established earlier this year. This included our newly expanded lab space which will allow us to provide cfDNA results to transplant patients across the U.S., said Peter Maag, Chief...


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