Biocartis' Idylla called some colorectal cancer samples negative that Sysmex Inostics's OncoBEAM called positive, but the clinical implications may be complex.
The firm said it can detect circulating tumor DNA with a mutational allele frequency of 0.001 percent, enabled by digital PCR and the firm's proprietary chemistry.
The firm plans to add more oncology tests, NIPTs and newborn screening assays through in-house development and partnerships with third-party assay makers.
At JP Morgan, Qiagen CEO Peer Schatz discussed a new digital PCR system and handheld reader for TB testing; Qiagen's acquisition of N-of-One; and its new sample prep system.
Roche said at the AMP annual meeting that it plans to commercialize the system in Europe with CE IVD marking for clinical applications and in the US with a 510(k) exemption.
