The company filed its first suit against Natera in March, claiming the firm's kidney transplant test infringes patents underlying CareDx's AlloSure test.
The Medicare contractor said in its draft guidance it would provide limited coverage for the cell-free DNA assay, which should be used as a supplemental test.
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 study adds to growing evidence around the utility of cell-free DNA testing in lung cancer patients, while highlighting shortcomings of the approach.
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.
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."
The assay monitors mutations across a patient's genome and matches them to mutations found in a patient's resected tumor and in DNA in the bloodstream.
The company is currently conducting clinical studies to validate AlloSure's technology — which underlies its kidney transplant test — in lung transplant patients.
St. Jude Children's Research Hospital scientists have treated infants with X-linked severe combined immunodeficiency using gene therapy in an early phase study.
In Nature this week: a genomic analysis of the snailfish Pseudoliparis swirei, ancient DNA analysis gives insight into the introduction of farming to England, and more.
