CAP
The projects signal ongoing concern among health regulators about the quality and regulation of lab-developed tests used to guide cancer treatment and gauge disease risk.
AMP, CAP Release Guidelines for Use of In Silico Approaches for Validating NGS Data Pipelines
Labs should not let in silico data supplant physical specimens in bioinformatic validation and should understand the limitations of such data.
If the Center for Genomic Interpretation's in silico quality assessment catches on with payors, some labs are sure to push back or propose data sharing as an alternative.
In new guidelines, an expert panel recommended IHC and PCR for certain cancer types and pointed out knowledge gaps supporting NGS in other settings.
AMP-led Expert Groups Release Clinical CYP2D6 Pharmacogenomic Testing Recommendation
The consensus guideline offers a two-tier categorization of alleles that are recommended for clinical CYP2D6 pharmacogenetic testing.