The LCD will provide coverage for the Decipher Prostate Biopsy genomic test for men with both favorable and unfavorable intermediate-risk prostate cancer.
The firm attributed the decline to reluctance of US customers to buy additional units of its Epi proColon colon cancer test amid reimbursement uncertainty.
The firm is looking to expand its sales internationally, as well as in the consumer-initiated market, but is being conservative with revenue growth estimates.
While some groups have communicated their concerns directly to the agency, stakeholders have also formed a new coalition to publicly take issue with FDA's actions.
The test, TruGraf, assesses differentially expressed genes in blood to rule out subclinical kidney transplant rejection in patients with stable renal function.
