At a Thermo Fisher-sponsored workshop, two companies argued for the clinical utility of PGx LDTs as FDA prepared to issue a warning against unapproved tests.
The solution uses machine learning to pare down somatic variant lists, simplifying the task of manually reviewing the output of sequence analysis pipelines.
Researchers investigated the possibility of picking up intra-tumor genetic heterogeneity in tumor exomes, identifying false-positives and technical noise.
Simulated population data suggests that the lifetime risk of cervical cancer is lower for women who stop screening after a negative DNA test for oncogenic HPV.
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.
The agency informed the public that most PGx tests haven’t been reviewed by the agency, and they should refer to information in FDA approved product labels when using such tests.
Consulting company McKinsey says diagnostics companies will have to combine genomic data analysis, electronic medical records, effective reimbursement strategies, and regulatory compliance in order to win.
A new report has found that researchers in Africa are still heavily dependent on funding from organizations in the US, Europe, and China, Nature News says.
