The Medicare contractor said in its draft guidance it would provide limited coverage for the cell-free DNA assay, which should be used as a supplemental test.
The firms plan to use Natera's cell-free DNA liquid biopsy assay to monitor patients' response to Amal's cancer vaccine in combination with immunotherapy.
CareDx claims that Natera is infringing on two of its patents related to non-invasive monitoring of organ transplant rejection through cell-free DNA analysis.
The company will launch a clinical version of its liquid biopsy assay in the second quarter and plans to launch clinical trials that make the case for reimbursement.
The company ran 668,600 tests during the year, a 30 percent increase from its 2017 testing volume.
Using BGI's sequencing technology, the firms plan to commercialize Natera's Signatera test in China and to develop reproductive health tests in "select markets."
Natera plans to harness One Lambda's commercial infrastructure when it launches its cfDNA kidney transplant rejection test this year.
In a clinical study Baylor researchers found that PreSeek, which Natera markets as Vistara, reliably detected dominant disorders in more than 400 pregnancies.
A brief recap of the news for Jan 11, 2019: Danaher, Natera, Chembio, and More
The company plans to focus on increasing its NIPT reimbursement as well as on pharmaceutical deals for its oncology test and launching a kidney transplantation test.