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CareDx Gets New Transplant Testing Tech, Plans IPO

CareDx, which two weeks ago entered into an agreement to acquire ImmuMetrix Inc., has announced that it intends to make an initial public offering (IPO) of common stock with the intent of realizing $50 million.

Brisbane, CA-based CareDx, which until recently was known as Xdx, is the maker of the AlloMap molecular expression test, a noninvasive test for monitoring the progress of heart transplant recipients.

ImmuMetrix has an exclusive license from Stanford University to a patent relating to the diagnosis of rejection in organ transplant recipients using cell-free DNA (cfDNA), which CareDx intends to develop into its next-generation transplant rejection monitoring test. This technology is intended to allow a test to distinguish between the blood-borne DNA of the donor heart and that of the patient.

CareDx said in its prospectus summary, filed with the U.S. Securities and Exchange Commission, that it plans to use some of the IPO proceeds to develop its cfDNA technology, and some to expand the usage of AlloMap.

AlloMap monitors the immune system by measuring gene expression of 11 rejection-related genes in a patient's peripheral blood to indicate the probability of moderate to severe acute cellular rejection (ACR) in heart transplant patients. The test has been commercially available as a CLIA-approved Laboratory Developed Test (LDT) since 2005 and was cleared by FDA in 2008 as a Class II medical device.

CareDX says the AlloMap molecular expression test was used at 105 of the 126 US transplant centers in 2013. However, only 54 of the use AlloMap on a consistent basis, and some of the clinicians at the centers are not using the tests.

The company says it has performed more than 55,000 AlloMap tests. After receiving CE Mark approval in 2011, CareDx also began marketing efforts in Europe and Canada.

CareDx has said that it hopes to have the cfDNA test for heart transplants ready for research purposes by the end of 2014, and that it hopes to start testing in kidney patients by the second half of 2015.

CareDx had a $3.5 million net loss on $22.1 million in revenue for 2013, compared with a loss of about $5.1 million in 2012 on revenues of $20.5 million. As of the end of March, the company had an accumulated deficit of $161 million.

Cromwell Schubarth of the Silicon Valley Business Journal observes that, "(T)he new filing by CareDx comes as IPO activity is showing signs of picking up again. It joins a dozen Bay Area companies that have publicly disclosed their plans to go public..."

Stephen Levy  is a contributor to Qmed and MPMN.

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