An OpenArray panel designed to simultaneously test for 17 viruses and 13 bacteria and protozoa was able to detect pathogens from human blood donor samples with an accuracy of about 95 percent.
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.
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.
A Winthrop-University Hospital team showed that demethylated circulating cell-free DNA from dying oligodendrocytes is a biomarker for relapsing-remitting MS.