Becton Dickinson said today that the US Food and Drug Administration has granted 510(k) clearance for its BD Max enteric viral panel, a molecular diagnostic test for the detection and differentiation of pathogens that cause viral gastroenter

A clinical assay from Zeesan Biotech to detect and identify 14 high-risk genotypes of human papillomavirus has been approved by the China State Food and Drug Administration, company announced recently. The MeltPro High Risk HPV test, which w

Qiagen announced today that the US Food and Drug Administration has approved the expanded use of the companys Therascreen EGFR RGQ PCR Kit to allow its use as a companion diagnostic for Pfizers Vizimpro (dacomitinib) for first-line treatment

Roche said recently that the US Food and Drug Administration has approved its Cobas EGFR Mutation Test v2 as a companion diagnostic test with AstraZenecas cancer drug Iressa (gefitinib) for first-line treatment of patients with non-small ce