The Elite InGenius has the sample prep capabilities typical of high-throughput platforms, yet it can run more samples than smaller instruments.
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.
Researchers separately found that the assay had high concordance with other techniques in cancers including colorectal and endometrial carcinomas.
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.
Hmong and Karen immigrants to the US quickly lost diversity in their microbiomes and experienced shifts in the microbes present in their guts.
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.
The market authorization came with a number of caveats and special requirements that 23andMe must follow when selling its PGx tests to consumers.
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.
An article in The Atlantic argues that the progress being made in science isn't keeping pace with the money and time being spent on research.
In Science this week: a CRISPR screen identifies sideroflexin 1 as a requisite component of one-carbon metabolism, and more.