Sold by: Kriv AI
Kriv AI deploys AWS HealthOmics pipelines for pharma R&D, biotech, CROs, diagnostic companies, and academic medical centers. Scope: HealthOmics Sequence / Variant / Annotation / Reference Stores, Ready2Run + private workflows (Nextflow DSL2 / WDL / CWL), variant calling (BWA-MEM + GATK + DeepVariant + Strelka2 + Mutect2), RNA-seq (STAR + Salmon + DESeq2), multi-omics integration via AWS Glue + OMOP Genomics CDM, clinical-genomic federation via AWS HealthLake + FHIR Genomics IG, 21 CFR Part 11 audit trail for CLIA LDTs + CDx, HIPAA Security Rule controls, GIAB validation, ACMG/AMP variant classification workflow. Three tiers: $100K / $175K / $275K + $40K Extra Pipeline (CRISPR screens / scRNA-seq / long-read PacBio / Oxford Nanopore / spatial transcriptomics / ChIP-seq / ATAC-seq / methylation). AWS Select + Databricks + Anthropic CPN. MDF-eligible.
Overview
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.
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.
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
- 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).
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Primary contact. info@kriv.ai · +1-732-433-5564 · https://kriv.ai/support
Response SLA. First response within 2 US business days (Mon–Fri 9 am – 6 pm ET, ex-US federal holidays). Active engagements: Engagement Lead within 4 business hours weekdays. CLIA LDT or FDA CDx submission-deadline engagements compress to same business day.
Onboarding SLA. First customer contact within 2 US business days of buyer inquiry / private-offer acceptance. Kickoff within 2–3 weeks of SOW; 5–10 business days for CLIA / CDx deadlines.
Escalation. (1) Engagement Lead (named in SOW) → (2) Practice Director (info@kriv.ai ) → (3) CEO Abhinav Dangri (info@kriv.ai ).
Communication. Dedicated Microsoft Teams channel; weekly 60-min video checkpoint; Friday written status. Customer SMEs 3–5 hrs/week (CSO, VP Genomics, Head of Bioinformatics, VP Translational Research, HIPAA Privacy Officer, CISO, IRB liaison, Head of Regulatory Affairs for CDx/LDT, CMIO).
Handoff. Word/Excel/PDF in customer secure share; private workflows as Nextflow DSL2 / WDL / CWL Git repo; reference architecture as .drawio + PNG; GIAB / SEQC validation reports as Excel + PDF; ACMG / AMP variant classification as Python / JSON; CDx / LDT documentation (Enterprise) as Word + PDF; Part 11 audit configuration as CloudTrail + S3 Object Lock templates.
Out of scope. Does NOT operate pipelines post-deployment (unless Managed Service retainer). Does NOT interpret variants clinically, licensed molecular pathologist review required. Issues no CLIA / CAP certifications. Does NOT submit FDA CDx / PMA / 510(k) filings. No legal / regulatory / clinical advice. No regulator outcome or medical-outcome guarantee.
AWS + Anthropic-side billing. AWS infrastructure + Anthropic API + Bedrock Claude consumption separate. Reference-data licensing (COSMIC, Illumina) Customer responsibility.
Holiday coverage. Closed on US federal holidays.