Blog

How 21 CFR Part 862 special controls separate analytical performance, clinical performance and claims about patient management for in vitro diagnostics.

Pharmacogenetic testing predicts how fast you metabolize certain antidepressants. How to call the star alleles yourself, and where the calls fail.

A working pipeline from FASTQ to an annotated variant list, with the QC steps and the filters that make 4.5 million variants readable.

A genome reader is really three things: the sequencer that produces reads, the aligner and variant caller that turn reads into a genome, and the browser that lets you look at it. Here is what each step produces, which tools we would run, and where they fail.

A technical account of pharmacogenetic panels, whole-genome sequencing, and the files they produce: coverage requirements, star-allele calling, CYP2D6 copy number, and where prices land in 2026.

A step-by-step guide to going from FASTQ files to gene-level counts, cell-composition estimates, and longitudinal comparisons using your own transcriptome data.

A working pipeline from FASTQ to annotated VCF for one human genome, with DeepVariant and GATK calling and benchmarking against GIAB truth sets.

A practical comparison of whole-genome and whole-exome sequencing, with the pipeline, tools, flags, and failure modes we would use to analyze either one.

A working pipeline that classifies the variants in a personal VCF under ACMG/AMP rules, and why automated calls disagree with expert curation.

A blood panel measures a few dozen analytes in one tube at one moment. Here is what that covers, why single results mislead, and how to store and analyze your own results over time.

The reagent cost of a 30x human genome is now in the low hundreds of dollars, but the price you pay depends on coverage, data delivery, and whether the lab is CLIA-certified. Here is the full cost stack, including storage and compute.

A step-by-step guide from raw FASTQ to an annotated variant table on your own machine, covering alignment, calling, QC thresholds and annotation.

A working list of blood, molecular, and continuous biomarkers worth tracking on yourself, with the biological-variation math that tells you when a change is real and when it is noise.

How 21 CFR parts 812, 50 and 56 govern clinical investigations of medical devices, including when an IDE application must be submitted to FDA.

Which vitamin and mineral analytes are worth measuring, which ones are nearly uninterpretable in serum, and how preanalytical handling and inflammation decide whether your panel means anything.

A working guide to blood biomarker analysis for technically fluent readers: what a single result can and cannot tell you, how to separate biological variation from signal, and how to structure your own longitudinal data.

A working method for reading your own labs: get the data as structured records, compare against your own history rather than the population reference interval, and use the reference change value to tell a real shift from noise.

The statutory clocks for a security assessment, a standard contract filing and certification of data exports from China, and what extends each.

How to tell Ensembl the database from ensemble methods in bioinformatics, then use both on your own whole-genome VCF: offline VEP annotation, plugin scores, and consensus calling across pipelines.

The three kinds of genetic testing for disease, which platform detects what, and how to work with the raw files yourself.