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The test can now be used to detect EGFR mutations in tissue and blood for lung cancer patients considering treatment with the tyrosine kinase inhibiting drugs Tarceva and Tagrisso.
Roche said it will offer the microarray-based Harmony IVD kit and Ariosa Cell-Free DNA System (AcfS) software to laboratories outside the US.
The test is based on a biomarker signature that consists of a core set of 31 genes associated with endotoxin tolerance in sepsis patients.
The Alere flu test detected fewer cases of influenza A in a recent study, which researchers attributed to low viral loads.
Executives of firms developing and launching various assays believe their diagnostic tests will be among the most important tools in controlling Zika.
The test runs on Roche's LightCycler 480 instruments or Cobas z 480 analyzers.
The new guidance could benefit Hologic and Roche, both of which market molecular blood screening tests authorized by the FDA under an investigational new drug study protocol.
Last week, the G-BA, a committee that decides about reimbursable medical services in Germany, said it will start a methods evaluation of noninvasive prenatal testing.
The firm has made a series of acquisitions and entered into strategic collaborations over the past couple of years aimed at rapidly growing its MDx offerings.
Laboratories have access to a growing number of antibody and molecular tests, thanks in part to FDA Emergency Use Authorizations, but they need more serology resources.