Panel backs expanded labelling for Digene test:
This article was originally published in Clinica
An FDA advisory panel has recommended that Digene's Hybrid Capture cytomegalovirus test be labelled as a signal amplified test. The expanded labelling is likely to support third-party reimbursement payments for the test as reimbursement levels for amplified tests are nearly twice those of non-amplified tests, said the Beltsville, Maryland-based company.
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