AWS HealthOmics Pipeline - Variant Calling + RNA-seq + Part 11 Audit
Kriv AI · Cybersecurity & IT
Certification per AWS Marketplace.
Evidence tier Source Confirmed · 4 captures on record
What the publisher says
As described on AWS Marketplace.
**Only 2 HealthOmics-specific Professional Services listings exist on AWS Marketplace today, PTP Quick Start and EPAM CORA. Neither leads with HIPAA + 21 CFR Part 11 + clinical-genomic federation. Kriv's HealthOmics Pipeline Implementation occupies that uncontested slot, compliance-forward, mid-market-priced, Nextflow-native, multi-omics + HealthLake federation in one fixed-fee engagement.**
AWS HealthOmics went GA late 2022 and added private workflows + Variant + Annotation Stores through 2024–2026. HIPAA-eligible and GxP-aligned. Most pharma R&D, biotechs, CROs, diagnostic companies, and AMCs still run custom EC2 + Batch + S3 pipelines, brittle, expensive, difficult to validate, lacking production audit trail for CLIA LDTs or FDA CDx submissions. **Illumina BaseSpace pricing changes + DNAnexus cost concerns drive active platform exits.** AWS HealthOmics is the natural receiver; the implementation service layer is thin.
Show the rest of the publisher’s description (5 more lines)
Existing AWS Marketplace listings confirm the gap. **PTP HealthOmics Deployment Quick Start** is rapid scope, limited compliance. **EPAM CORA for HealthOmics** is GxP-ready, custom-priced $200K–$1M+, EPAM-platform-locked. Off-Marketplace: Seqera implementation partners $75K–$250K; IQVIA / Roivant / Embassy Cloud bioinformatics $150K–$400K. DRAGEN / Sentieon / NVIDIA Clara Parabricks are software-only.
**HealthOmics architecture deployed.** Sequence Stores (FASTQ/BAM/CRAM). Variant Stores (VCF/gVCF + Lake Formation cohort query). Annotation Stores (VEP/SnpEff/Annovar). Reference Stores (GRCh38, GRCh37, T2T-CHM13). Ready2Run workflows + Private Workflows (Nextflow DSL2 / WDL / CWL). **Variant calling:** BWA-MEM → BQSR → GATK HaplotypeCaller / DeepVariant / Strelka2 / Mutect2 → VEP. **RNA-seq:** STAR → Salmon → DESeq2 → GSEA. **scRNA-seq:** Cell Ranger → Scanpy/Seurat. **CRISPR screens:** MAGeCK/BAGEL. Multi-omics via Glue ETL + OMOP Genomics CDM. Clinical-genomic federation via HealthLake FHIR R4 + FHIR Genomics IG. Validation: GIAB germline; SEQC RNA-seq; ACMG/AMP variant classification. Knowledge base: ClinVar, COSMIC, dbSNP, gnomAD. Compliance: HIPAA §164.308/312/316; 21 CFR Part 11 audit trail (CloudTrail + S3 Object Lock); FDA CDx / PMA / 510(k) documentation support. Cost: S3 Intelligent-Tiering + Glacier Deep Archive. Governance: Lake Formation + IAM per role.
**Week-by-week.** W1 Scoping (pipeline scope; data inventory; HealthOmics regional availability; reference genome + annotation KB selection). W2 HealthOmics setup (Sequence + Variant + Reference Stores + IAM baseline). W3 First pipeline (Ready2Run or private workflow; sample validation against GIAB). W4 Annotation + QC dashboards: Foundation closes (30-day warranty). W5 Standard — additional pipelines + Bedrock variant-interp draft (mandatory pathologist review). W6 Standard: federation via HealthLake + FHIR Genomics IG + Part 11 audit trail (60-day warranty). W7–8 Enterprise: multi-omics (proteomics + metabolomics) + CDx/LDT documentation. W9–10 Enterprise,production + 90-day hypercare.
**Three tiers.** Foundation $100K (6 wk; 1 pipeline, variant calling OR RNA-seq; Ready2Run; Sequence + Variant + Reference Stores; GIAB validation; HIPAA baseline; 30-day warranty) for mid-biotech precision oncology, pharma migrating from BaseSpace/DNAnexus, CRO single-sponsor. Standard $175K (8 wk; multi-pipeline; private workflows; Lake Formation; Bedrock Claude variant-interp draft; tumor-normal matched; HealthLake + FHIR Genomics IG; 60-day warranty) for mid-pharma R&D, diagnostic companies, CRO multi-sponsor, AMCs. Enterprise $275K (10 wk; full multi-omics; CRISPR screens; CDx/LDT documentation; clinical-genomic federation; Part 11 audit trail; FDA submission support; 90-day hypercare) for large pharma R&D, top-25 diagnostic companies, AMC genomic medicine, population genomics. Optional Extra Pipeline $40K each. EDP-eligible — pipeline engagement fees ($100K–$275K) count toward your AWS Enterprise Discount Program commitment (up to 25%). HealthOmics sequence storage and compute costs bill separately through your AWS account. Contact info@kriv.ai to structure a private offer against your EDP or PPA.
**Important disclosures.** Kriv does NOT operate pipelines post-deployment (unless Managed Service retainer). Does NOT interpret variants clinically, licensed molecular pathologist review required; Bedrock variant-interp draft only. Does NOT issue CLIA / CAP certifications. Does NOT submit FDA CDx / PMA / 510(k) filings (Customer RA retains filing responsibility; Kriv provides submission-ready documentation at Enterprise). No legal / regulatory / clinical advice. No FDA / CLIA / CAP / OCR outcome guarantee. No medical-outcome guarantee. AWS + Anthropic + Bedrock + HealthOmics per-run costs separate. Reference-data licensing (COSMIC, Illumina) Customer responsibility. No HealthOmics API stability guarantee. Anthropic CPN membership does not constitute endorsement.
Highlights
Highlighted by the publisher on AWS Marketplace.
Only 2 HealthOmics-specific PS listings on AWS Marketplace, Kriv's HIPAA + 21 CFR Part 11 + clinical-genomic federation positioning is uncontested. HealthOmics Sequence / Variant / Annotation / Reference Stores + Ready2Run + private workflows (Nextflow DSL2 / WDL / CWL). Variant calling (BWA-MEM / bwa-mem2 + GATK HaplotypeCaller + DeepVariant + Strelka2 + Mutect2) + RNA-seq (STAR + Salmon + DESeq2 + GSEA). Illumina BaseSpace sunset + DNAnexus cost concerns = platform-exit tailwind.
Multi-omics + CRISPR screens + scRNA-seq + long-read via Ready2Run + Customer-authored Nextflow / WDL / CWL.** GIAB (Genome in a Bottle) truth-set validation for germline SNVs; SEQC for RNA-seq; ACMG / AMP variant classification workflow (Richards et al. 2015). AWS HealthLake FHIR R4 + FHIR Genomics Implementation Guide clinical-genomic federation. Bedrock Claude variant-interpretation drafts (Standard / Enterprise), licensed molecular pathologist review mandatory. CDx / LDT documentation.
AWS Select + Databricks + Anthropic CPN , MDF-eligible under AWS genomics / life sciences MDF program. Three tiers: Foundation $100K (single pipeline + GIAB validation + HIPAA baseline, 6 weeks); Standard $175K (multi-pipeline + private workflows + HealthLake + FHIR Genomics IG + Bedrock variant interpretation draft, 8 weeks); Enterprise $275K (full multi-omics + CRISPR + CDx/LDT documentation + 21 CFR Part 11 audit trail + FDA submission support + 90-day hypercare, 10 weeks).
Agent build and provenance
See the full provenance
The layer-by-layer build, the evidence behind each claim, the risk basis and the cross-marketplace links are open to any account. Some rows are disclosed, some the source leaves Unknown; a free account shows you which.
Compliance
- FedRAMPConfirmedNot listed90%, registry-checkedNo FedRAMP Marketplace entry matched this vendor's domain, checked 2026-08-27registry recordas observed 2026-08-27
Confirmed means matched to a public authoritative registry. Claimed means the vendor or its listing states it, not yet cross-checked. A framework not shown was not found in any source we hold, which is not evidence against it. Not listed means a scoped registry check found no match for this vendor's domain: a No is a scoped registry check, not a compliance judgment. Confidence bands: 95% domain-verified, 90% registry-checked, 80% self-attested, 70% weak signal. Self-attested items marked “vendor's site” are gathered from the vendor's own website and are not verified by us.
Vendor
External enrichment · as of 2026-08-29
Sources
Publisher resources
3 linksLinked repositories
Unknown means this listing does not publish a repository. It is not a statement that the code is closed, and a linked repository is not a claim that the publisher wrote it: the registry computes that relationship privately and does not publish it.
Evidence risk is the share of the build you cannot see before you deploy, not a security rating. Sign in to see the layer-by-layer basis for this band.